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Last updated: 10:11 21/12/2012

Senior Clinical System Programmer

Reference number: 1988 Apply for this job Apply for this job »
Type: Permanent, full time Location: Office based in Marlow, UK

Job Description

Summary:

 Working within an expanding group of Data Managers and Programmers worldwide, the successful candidate will develop EDC systems used on Clinical studies.  On a daily basis the successful candidate will work closely with Data Managers, reviewing specifications and providing technical input to develop EDC solutions.  Alongside the Data Manager the successful candidate will  work with other groups such as Clinical Research functions and Biostatistics to  ensure that the EDC system meets the needs of all and is of high first time technical and general quality. 

 As needed the successful candidate will work with other members of Clinical Programming to progress departmental initiatives and training.

 The Role:

  • Under the direction of management leads the design, development, validation, implementation, and provides ongoing support of electronic systems e.g., Electronic Data Capture (EDC), reporting/business intelligence tools (e.g., Business Objects, Spotfire) and programs (e.g., SQL, PL/SQL) according to the study specifications (e.g. Protocol, data Management Plan, Edit Check Specifications).
  • Analyse Clinical Study design requirements against third party system specifications to support the implementation of electronic systems (e.g., electronic diaries) used in clinical studies. 
  • Assist in the validation (self QC or peer review) of electronic systems and programs as implemented internally or through external vendors according to current regulatory requirements.
  • Provide leadership and content expertise for programming activities in support of Global Development to effectively manage data capture, review and database lock activities
  • Participates in team discussions around process improvements.
  • Support Corrective Action and Preventive Action initiatives.
  • Where required support the Computer System Validation activities associated with the development and roll-out of new systems or components.
  • Where required provide support to Departmental initiatives around training, process improvements and novel solutions to be used within the EDC system.
  • This position has matrixed responsibility to Clinical Data Management, Clinical Programming, Statistical Programming, Biostatistics, and the Clinical Research functions as well as external vendors, to enable the analysis and implementation of clinical information technology solutions.

Experience/Qualifications required

Skills and Attributes:

  • Ability to effectively interact with and influence others without direct reporting relationships
  • Technical abilities and skills in analysis, design, specification and programming of computer systems
  • Knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies
  • Analytical, problem solving and technical skills
  • Knowledge of Clinical Data Management and Clinical Programming methodologies as well as current and emerging global industry standards
  • Planning, organisational, and project management skills
  • Excellent communication skills
  • Negotiation skills
  • Conflict management skills
  • Attention to detail with high quality outputs
  • Computer skills (word processing, spreadsheets, graphics, PowerPoint)
  • Working knowledge of industry standards related to clinical study data management activities would be desirable (eCRF design, data standards and database design etc.)
  • Ability to travel 5%

 
 Experience:

  • Previous experience of leading eCRF builds within a clinical programming organisation, preferably within a medium-large pharmaceutical company or CRO.
  • Previous experience of working with EDC systems.  Experience with Medidata’s Architect and / or with Oracle’s Central Designer is highly desirable  Previous  experience of working with Reporting/Business Intelligence Tools (e.g. Business Objects, Spotfire) would be advantageous

 Qualifications:

 Degree or equivalent experience in Computer Science, Life Science or related field

Senior Clinical Data Manager

Reference number: 1980 Apply for this job Apply for this job »
Type: Permanent, full time Location: Marlow, UK

Job Description

Summary:

 The successful candidate must conduct his/her work activities in compliance with all of our client’s internal requirements and with all applicable regulatory requirements. Our client’s internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

 The Senior CDM (Clinical Data Manager) within Clinical Data Management will provide specialised knowledge and detailed attention to carry out data management data review activities in support of one or more clinical research studies. The position is responsible for-

 Working within clinical study teams as an extended team member.

Executing the clinical data management operations against project timelines, and any other priorities.

Using defined department metrics as a framework for timely and quality clinical data management deliverables.

Collaborating with peers within and outside the organisation to pro-actively manage data availability and integration.

Acting as a Lead Data Manager as determined by ability and proficiency level in essentials skills.

 Jobs Supervised (Titles):

Direct: None

Indirect: Clinical Data Coordinators, Clinical Data Integration Programmers, Clinical System Programmers, Medical Coding Specialists

 Key interfaces:

Routine contacts with Development Operations and Therapeutic Area Staff.

External interfaces include:  Various Contract Research Organisations and other vendors for data services (e.g. Reading Centres, Central Laboratories, Phase I units)

 The Role:

 KEY DUTIES AND RESPONSIBILITIES:

Lead Data Manager

Responsible for the role which includes executing the design, documentation, testing, and implementation of data collection systems and processes in support of the clinical study teams. Training of study site personnel in CRF completion, and data clarification processes. Coordination of all Data Management Data Review activities and any other Clinical Study Team Data Review (e.g. Masked Data Review). Ensuring completion of all activities leading to the Study Database Lock.

Study Data Manager

Responsible for the role which includes the execution of the data review strategy for one or more studies as defined by the individual study Data Management Plan. Initiation and management of the data clarification process, coordinating with other stakeholders to ensure appropriate resolution to all data clarifications prior to database lock.

Study Data Associate

Assist with the role which includes development of clinical data management study documentation (e.g. Data Management Plan, Edit Check Specifications, etc.), and supporting the review in accordance with existing standards. Leadership of user acceptance testing activities of technologies implemented at a study level.

Clinical Study Team Member

Assist with the role which includes representation of the clinical data management and programming organisation in one or more clinical study teams.

Client personnel / Subject Matter Expert

Include implementation of quality, efficient, and consistent approaches to carrying out clinical data management tasks. Delivering training to clinical data management and other departments, as necessary. Report process gaps and potential misconduct during clinical studies to management. Support Corrective Action and Preventive Action initiatives.

Experience/Qualifications required

Skills and Attributes:

 Knowledge and understanding of regulatory guidelines for the use of computer systems in clinical trials

  • Knowledge of Research and Development and an understanding of regulatory guidelines/requirements related to R & D (e.g., ICH, GCP, safety reporting)
  • Working knowledge of global standards related to clinical study data management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.).
  • Ability to effectively interact with and influence others without direct reporting relationships
  • Ability to multi-task and prioritise
  • Planning, organisational, and project management skills
  • Document writing skills
  • Attention to detail with high quality outputs
  • Negotiation skills
  • Conflict management skills
  • Proactive and critical evaluation of varied and multiple aspects of trial implementation to ensure timely completion and with requisite quality
  • Ability to meet challenging milestones
  • Analytical and problem solving skills
  • Computer skills (word processing, spreadsheets, graphics, PowerPoint)

 Ability to travel 5%.

 Experience:

 ·         Previous work experience within a clinical data management organisation, preferably within medium-large pharma or CRO.

 Qualifications:

 ·         Degree or equivalent experience in Clinical Research, Computer Science, Project Management or related field.

Senior Clinical Scientist

Reference number: 1978 Apply for this job Apply for this job »
Type: Permanent, full time Location: Basingstoke, UK

Job Description

Summary:

 Leads the study team to design, develop and deliver the clinical study; Authors protocols, ICFs and study related plans developed.

 The Role:

 Responsible for the clinical review and approval of Case Report Forms (electronic as applicable) and provides clinical input into corresponding completion guidelines.

Oversees the management of CRO activities and other clinical vendors to ensure the quality is consistent with requirements; Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required.

Develops and monitors budget for clinical development program and may negotiate budgets and contracts with CROs, investigative sites (as applicable) and vendors.

Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities; May mentor other Study Managers.

Experience/Qualifications required

Experience:

 • Generally varied experience in clinical research within a pharmaceutical company or CRO or similar organisation

 Qualifications:

 • Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred, but not required.

Clinical Research Associate

Reference number: 1974 Apply for this job Apply for this job »
Type: Contract, fixed term Location: Basingstoke, UK , office based

Job Description

Role/Purpose

1.    Be responsible for the set-up, co-ordination, monitoring and closeout of national and international clinical studies

2.    To conduct clinical research activities to time and within budget

3.    Be responsible for ensuring that studies are conducted to the required GCP, regulatory, SOP and quality standards. 

4.    To ensure both our client’s and its clients’ interests are presented and   maintained to a highly professional standard

1.    General Responsibilities

a.    Ensure all clinical trials comply with our client’s SOPs, ICH/GCP, Statutory Instrument, EU Directive and all regulatory requirements

b.    Monitor and adhere to study budgets

c.    Prepare and monitor study plans and timelines where required

d.    Plan, identify and conduct pre-selection visits on suitable primary and secondary care centres to join our client’s network across the UK and Europe

e.    Liaise with the Project Manager as required to ensure a good level of  awareness on study issues and agreement to study commitments

f.     Ensure regular communication of clinical trial issues and progress to our client’s clinical study team

g.    Predict difficulties and resolve unexpected problems or delays involving internal/external contacts as appropriate.

h.    Produce regular and ad hoc reports and presentations on the progress of clinical trial activities as requested

i.      Manage the preparation, review  and distribution of study documentation as required

j.     Ensure all regulatory, insurance, ethical requirements and investigator agreements are in place for each Investigator centre prior to site initiation

k.    Co-ordinate the conduct of an investigator meeting or advisory board at clients request and be able to present study information on the protocol or guidance on GCP as necessary.

l.      Assist the Directors  or Clinical Project Managers with reports, feasibility, presentations and attendance at client or supplier meetings as requested

2.    Study conduct

a.    Oversee and monitor the management of clinical trials by regular investigator site / other third parties where they are involved

b.    Plan and conduct accompanied visits as agreed with the Clinical Research Manager

c.    Monitor recruitment rate, maintain patient tracking and take initiatives to ensure targets are met.

d.    Ensure that a high quality safety monitoring process is operated and that procedures for reporting adverse events and serious adverse events are strictly adhered to.

3.    Study close

a.    Ensure that all study activities are completed according to the study plan in line with current SOPs

b.    Ensure the study is archived according to the sponsor or our client’s requirements

4.    General

a.    Remain up to date with therapeutic knowledge, current medical practice, the clinical research environment and pharmaceutical regulations and guidelines in order to ensure consistent best practice across all activities

b.    Contribute in review of standard operating procedures

c.    Carry out any additional duties as necessary to facilitate the development of our client’s business as a whole

 

Experience/Qualifications required

Good intellectual, organisational, planning, and interpersonal skills.

Self motivated, flexible, diplomatic and able to show initiative

Excellent communicator, able to complete tasks to deadlines and provide attention to detail

Team player

Willing to travel and spend several consecutive nights away from home

Full driving licence

 Experience:

 A minimum of 6-12 months experience involved in clinical research activities

 Qualifications:

 Life sciences degree or suitable nursing qualification

Senior Clinical Research Associate

Reference number: 1973 Apply for this job Apply for this job »
Type: Contract, fixed term Location: Field based - Madrid or Barcelona

Job Description

Summary:

 Administration and full site responsibility for clinical studies according to Company SOPs, ICH-GCP and local regulations.

May act as mentor for less experienced CRAs.

Ensures clinical trials are monitored such that subjects’ rights, safety and well-being are protected and the clinical trial data are reliable.

 

The Role:

 

Job duties and responsibilities:

 

Involved in more complex clinical trials.

Acts as a member of the project team with the goal to contribute towards efficient management of trials.

Assists the project managers in the preparation and review of protocols and informed consent forms.

Contributes to CRF design and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.).

Involved in recruitment of potential investigators, preparation of EC/IRB submissions, notifications to regulatory authorities, translation of study related documentation, organisation of meetings and other tasks as instructed by the project manager.

Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department.

Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports.

Experience/Qualifications required

Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports.

Performs initiation visits: trains investigators and other trial staff in the protocol and data collection methods to ensure collection of patient data is accurate, complete, and conforms to protocol requirements, in accordance with local regulations, ICHGCP and Company SOPs.

Performs monitoring visits: ensures adherence to protocol, accurate data collection via comprehensive source document verification, and investigational

product/biological samples/supplies accountability.

Communicates effectively with site personnel, including the principal investigator, and Company management to relay protocol/study deviations and ensure timely implementation of corrective actions.

Develops and maintains good working relationships with investigators and study staff, serving as an ambassador to promote the Company's high quality and ethical image.

Maintains study tracking, in accordance with the demands of the study.

Performs data management review, including in-house CRF review, and alerts project managers and data managers to emerging issues with CRF completion.

Identifies and processes Serious Adverse Events according to the procedures defined by the study team.

Demonstrates understanding of the SAE reporting process to regulatory authorities.

May write SAE narratives to support pharmacovigilance activities.

Liaises with data management to resolve data discrepancies and ensure all data management study goals are met.

Prepares and performs closeout visits according to the protocol, local laws, ICH-GCP and Company SOPs.

Undertakes feasibility work when required.

Prepares accurate and timely visit reports from all types of visits.

May be involved in preparation of status reports for clients.

Functions as a mentor, assisting with the training and developing of less experienced CRAs via shadow or co-monitoring visits.

Assists with the development of SOPs.

Performs other duties as assigned by management.

Travels as necessary according to project needs.

Clinical Research Associate II

Reference number: 1972 Apply for this job Apply for this job »
Type: Permanent, full time Location: Madrid Spain - office based

Job Description

Summary:

 The job holder will perform the clinical monitoring aspect of designated projects in accordance with Company SOPs.

 The Role:

 Responsibilities will include managing clinical monitoring activities in addition to the ownership of investigator sites, including investigator/site selection, collating regulatory documentation, initiation and monitoring (source data verification, drug accountability and data collection) in accordance with ICH GCP guidelines.

  Skills:

 Excellent interpersonal, verbal, and written communication skills, (including experience in making presentations).

Client focused approach to work.

Ability to manage multiple and varied tasks and prioritise workload with attention to

Experience/Qualifications required

 Experience:

 Solid previous CRA experience in clinical research.

  Qualifications:

 Educated to degree level (biological science, pharmacy or other health related discipline preferred) or equivalent nursing qualification/experience.

 

Clinical Research Associate 2

Reference number: 1971 Apply for this job Apply for this job »
Type: Contract, fixed term Location: Field based in Spain

Job Description

Summary:

 We are assisting this CRO to fill a field based CRA vacancy in Spain, ideally based in Madrid or Barcelona. This is a 12 months fixed-term contract initially, but might lead to a permanent position.

 The successful candidate will take on the following responsibilities:

 Administration and full site responsibility for clinical studies according to SOPs, ICH-GCP and local regulations.

 Ensures clinical trials are monitored such that subjects’ rights, safety and well-being are protected and that the clinical trial data are reliable.

 The successful candidate will also be involved in more complex clinical trials.

 The Role:

 Acts as a member of the project team with the aim of contributing towards the efficient management of trials.

 Assists the project managers in the preparation and review of protocols and informed

consent forms.

 Contributes to CRF design and clinical trial document development as they pertain to

clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.).

 Involved in recruitment of potential investigators, preparation of EC/IRB submissions,

notifications to regulatory authorities, translation of study related documentation,

organisation of meetings and other tasks as instructed by the project manager.

 Negotiates investigator budgets and assists with the execution of site contracts with

support from the legal department.

 Oversees all aspects of study site management to ensure high quality data resulting

in consistently low query levels and in good Quality Assurance reports.

 Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports.

 Performs initiation visits: trains investigators and other trial staff in the protocol and data collection methods to ensure collection of patient data is accurate, complete, and conforms to protocol requirements, in accordance with local regulations, ICH/GCP and SOPs.

 Performs monitoring visits: ensures adherence to protocol, accurate data collection via comprehensive source document verification, and investigational product/biological samples/supplies accountability.

 Communicates effectively with site personnel, including the principal investigator, and  management to relay protocol/study deviations and ensure timely implementation of corrective actions.

 Develops and maintains good working relationships with investigators and study staff, serving as an ambassador to promote our client’shigh quality and ethical image.

 Maintains study tracking, in accordance with the demands of the study.

 Performs data management review, including in-house CRF review, and alerts project

managers and data managers to emerging issues with CRF completion.

 Identifies and processes Serious Adverse Events (SAE) according to the procedures defined by the study team.

 Demonstrates understanding of the SAE reporting process to regulatory authorities.

 May write SAE narratives to support pharmacovigilance activities.

 Liaises with data management staff to resolve data discrepancies and ensure all data management study goals are met.

 Prepares and performs close-out visits according to the protocol, local laws, ICH-GCP and SOPs.

 Undertakes feasibility work when required.

 Prepares accurate and timely visit reports from all types of visits.

 Maybe involved in preparation of status reports for clients.

 Functions as a mentor, assisting with the training and developing of less experienced CRAs via shadow or co-monitoring visits.

 Assists with the development of SOPs.

 Performs other duties as assigned by management.

 Travels as necessary according to project needs.

Experience/Qualifications required

Skills:

 Demonstrates a strong working knowledge of ICH-GCP, relevant SOPs and regulatory guidance, as well as the ability to implement.

 Resolves project related problems and prioritises workload to meet deadlines with

little support from management.

 Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.

 Understands the basics of clinical trials methodology.

 Demonstrates a working knowledge of protocols and indications being studied.

 Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments and positive interactions with customers and colleagues.

 Demonstrates good communication skills (written and verbal).

 Demonstrates good interpersonal skills.

 Collects data of a consistently high standard.

 Demonstrates mentoring skills.

 Conducts formal presentations to a wide variety of audiences including colleagues,

investigative staff and clients, with proficiency.

 Provides accurate and timely administration.

 Acquires and demonstrates a good knowledge of the company.

 Works with minimal supervision.

 Possesses basic understanding of financial management and clinical trial budgets.

 Possesses practical knowledge of IT tools and systems used by the company.

 Demonstrates flexibility.

 Ability to drive and availability for domestic and international travel, including overnight

stays.

 Language Skills:

 English and Spanish

 Experience:

 Demonstrated experience as CRA either in CRO or pharmaceutical industry or investigational site.

 Qualifications:

 Graduate, postgraduate, or equivalent, ideally in a scientific or healthcare discipline.

Oncology Team Leader

Reference number: 1966 Apply for this job Apply for this job »
Type: Permanent, full time Location: Harlow, Essex

Job Description

The Role:

 Responsibilities:

 ·         Provide direction and guidance to the Biology teams working on the projects, to meet development timelines and milestones.

 ·         Help to coordinate the work of multiple in vitro and in vivo contract research establishments.

 ·         Provide input into the development, and implementation, of in vitro and in vivo pharmacology and pharmacodynamic assays for novel oncology targets.

 ·         Help to supervise the development of biomarker assays, as indicators of efficacy and for translational medicine studies to select responders in a clinical setting. 

 ·         Collection and interpretation of data, preparation of reports and delivery of presentations internally and at project meetings with other collaborators.

 ·         Maintaining an up-to-date understanding of scientific developments within appropriate fields.

Experience/Qualifications required

Skills:

 Candidates should be familiar with genomic and proteomic profiling technologies, biochemical and cellular pharmacology and other basic molecular and cell biology skills. The successful candidate will have the ability to multitask and drive projects, working across multiple disciplines in a matrix organisation. Excellent written and verbal communication skills and the ability to clearly communicate scientific objectives and project results are required.

Experience:

 The candidate should have 8 to 10 years experience, which includes management of people and working within multidisciplinary teams. Previous experience in the field of oncology translational medicine, biomarker discovery, and drug development is desirable.

 Qualifications:

 PhD degree.

Clinical Trial Co-ordinator

Reference number: 1959 Apply for this job Apply for this job »
Type: Permanent, full time Location: Brussels, Belgium

Job Description

Background:

 Our client is actively recruiting for a Clinical Trial Co-ordinator to join its expanding global company in Belgium. This is a  permanent, office based opportunity. By working for our client you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits. 

 Summary:

 Due to a period of sustained expansion, a number of outstanding career opportunities have arisen within the Company, including the need for a talented Clinical Trial Co-ordinator to join its experienced team.

 The Role:

 Ensure administrative work of clinical trials is satisfactorily carried out: create Investigator Files and other study information, booklets, worksheets, etc.

  • Ensure timely translation and validation process of study materials (e.g. patient diaries, instructions, IC)
  • Provide investigators with all forms and lists to start the site evaluation and site validation (initiation and start of study information)
  • Ensure timely ordering of study tools
  • Preparation of ethical and regulatory submissions
  • Ensure protocol initiation processes 
  • Organisation and documentation of regular study meetings 
  • Organisation and documentation of local investigators meetings 
  • Provide professional presentation of study materials for CRA and investigator training
  • Archiving of processes, including electronic SORF and Trial Master File

Experience/Qualifications required

Skills:

  • Good knowledge of the clinical trial process 
  • Strong organisational and communication skills 

 Language Skills:

  • Fluency in Dutch and French languages (written and spoken)
  • Fluency in English (written and spoken)

 Experience:

  • Previous experience in a similar role would be highly advantageous

 Qualifications:

 High school degree or equivalent

 Company Information:

Our client is a UK-based, dynamic privately owned full service Contract Research Organisation with presence in over 40 countries worldwide. It has been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over a decade. The Company prides itself in providing high quality, flexible and professional services and solutions to its clients. The Company has a wealth of experience in managing clinical trials in all major therapeutic areas including oncology, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

Company employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of clinical trials across the full life-cycle of the drug development process from the CRO perspective. The Company has strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. The Company offers a competitive salary and rewards package. 

Clinical Research Associate

Reference number: 1958 Apply for this job Apply for this job »
Type: Permanent, full time Location: Brussels, Belgium

Job Description

Background:

 Our client is actively recruiting for clinical professionals to join its expanding global company.  By working for our client you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits. In the past 12 months, our client company has expanded into 17 new countries with offices opening across the globe. Our client offers a competitive salary and rewards package.

Summary:

 The Clinical Research Associate (CRA) will identify, select, initiate and close out appropriate investigational sites for Clinical Studies. The successful candidate will monitor these sites in order to ensure compliance to the study protocol, Standard Operating Procedures, applicable regulations and the principles of ICH-GCP. The CRA will also be charged with ensuring the quality and integrity of data, compliance with the relevant SOPs and regulatory requirements and study completion on time and within budget.

 The Role:

 Ensuring the management of trials is done in compliance with ICH, GCP, Company/Sponsor global standards, local laws and regulations.

  • Ensuring clinical trials are effectively executed and completed within budget, timelines and meeting enrolment commitments as well as routine updating of CTMS and other clinical systems. Pro-active trial management to identify challenges, develop effective mitigation plans and to appropriately escalate and inform all relevant parties.
  • Manage site pre-selection and validation process.
  • Support local investigator meetings, ensure contracts and applicable regulatory documentation is obtained prior to study start, facilitation of all aspects of IRB/ERC review and HA approvals as needed.
  • Act as main point of contact for all logistical and operational issues and facilitate general communication.
  • Oversee drug and clinical supplies management to ensure sites have timely availability of required materials to avoid disruption of protocol deliverables and to oversee appropriate final disposition of IMP.
  • Ensure clinical study site close-out in accordance with local regulations and ensure dissemination of clinical trial results to the participating study investigators.
  •  Oversee appropriate file archiving of all relevant study materials in accordance with local law and Company/Sponsor guidelines.

Experience/Qualifications required

Skills:

 Clear understanding of the drug development process

  • Should be able to identify problems and escalate to management as appropriate: Specific examples of common problems include: 1) low patient recruitment, 2) inadequate sponsor staff to meet business needs, 3) compliance issues and study quality, 4) working with regulatory issues and broader organisation, 5) Identify and mitigate FA deliverables that will hinder meeting milestones
  • Should have strong organisation and team leadership skills and ability to focus on multiple deliverables and sites simultaneously
  • Able to build professional relationships with a wide range of people including investigators, internal employees
  • Contribute to development of country specific trial and site budgets
  • Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines
  • Excellent presentation skills including the ability to meet exacting standards and a keen attention to detail

 Language Skills:

  • Fluency in English language (both written and spoken)
  • Fluency in French and Dutch (both written and spoken)

 Attributes:

  • Willingness and ability to travel up to 60% of the time
  • Willingness and ability to be based in office based Brussels, Belgium
  • Must be permitted to work the EU

 Experience:

 Significant experience in performing a Clinical Research Associate role

  • Work experience within either a hospital, medical / research centre environment, Contract Research Organisation or pharmaceutical company
  • Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials

 Qualifications:

 Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline

Clinical Research Associate

Reference number: 1955 Apply for this job Apply for this job »
Type: Permanent, full time Location: Midlands and the South East, UK

Job Description

Summary:

 Responsible for monitoring our client’s clinical trials to ensure that investigators are conducting the research within requirements of the clinical protocol, that research is conducted in accordance with applicable federal regulations / EU Directive and guidelines, that data quality on initial review meets acceptable clinical standards, and the rights and safety of human subjects involved in a clinical study are protected.

 Reports to CRA Manger, Clinical Monitoring.

 The Role:

 ·         Participates in the investigator recruitment process. Performs initial qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically.

·         Coordinates activities with the site in preparation for the initiation of studies. Works with the Study Start-up group to obtain regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with Study Start-up Group and site staff to obtain regulatory (IRB/IEC) approval of study specific documents.

·         Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF, monitoring activities and study close-out activities.

·         Trains site staff on the EDC system and assists in verifying site computer system.

·         Conducts periodic site file audits to ensure compliance with GCPs and our client’s standard operating procedures.

·         Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor.

·         Prepares monitoring reports and letters using approved (by our client or the sponsor) forms and reports whilst adhering to study specific timelines.

·         Documents accountability, stability and storage conditions of clinical trial materials as required by the sponsor. Performs investigational product inventory.  Ensures return of unused materials to designated location or verifies destruction as required.

·         Performs study close out visits.

·         Reviews the quality and integrity of the patient clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.

·         Serves as primary contact between our client and the investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

·         Assists with, and attends, Investigator Meetings for assigned studies.

·         Actively participates in study specific team calls on a weekly basis

·         Assists with final data review and query resolution through database lock.

·         Authorised to request site audits for reasons of validity.

Experience/Qualifications required

Skills and Attributes:

 ·         Knowledge of clinical research process and medical terminology.

·         Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.

·         Good organisational and interpersonal skills.

·         Ability to reason independently and recommend specific solutions in clinical settings.

·         Understand electronic data capture including basic data processing functions.

·         Understand current GCP/ICH guidelines applicable to the conduct of clinical research.

·         Able to qualify for a major credit card.

·         Valid driver’s licence; ability to rent automobile.

·         Willingness and ability to travel domestically, as required, 50% to 75% of the time.

·         Computer literacy and knowledge of electronic data capture preferred. 

·         Must possess good written and verbal communication, interpersonal, and organisational skills. 

 Experience:

 ·         Six to twelve months experience in monitoring and/or coordinating clinical trials required; experience in an oncology clinical trial setting a plus.

 Qualifications:

 ·         BSc/BA in one of the life sciences with a minimum of 6-12 months of field monitoring experience or equivalent amount of education/experience.

Senior Clinical Research Scientist

Reference number: 1939 Apply for this job Apply for this job »
Type: Permanent, full time Location: Hampshire

Job Description

Summary:

 This function will lead the study team to design, develop and deliver the clinical study. Authorship of protocols, ICFs and study related plans.

 The Role:

 Responsible for the clinical review and approval of Case Report Forms and provides clinical input into corresponding completion guidelines.

 Oversees the management of CRO activities and other clinical vendors to ensure the robustness of their systems and that quality is consistent.  Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required.

 

The Senior Clinical Research Scientist will be responsible for the execution and management of global clinical studies in CNS and will have previous experience in a CRO or Pharmaceutical company at a similar level. He/she will manage clinical outsourcing activities and will be the author of protocols, informed consent forms and study related plans.

 

Experience/Qualifications required

Experience:

 Must have CNS experience / background. (Psychiatry - Alzheimer, Parkinson, Depression, Schizophrenia).

 Previous vendor management experience and management of multi-centred global (Phase II-IV) clinical trials is required.

 Must have EU experience ie. not just UK experience.

 APAC experience desirable.