job details for:
Clinical Research – Senior Clinical Research Associate Jobs - Berkshire

Clinical Research – Senior Clinical Research Associate Jobs - Berkshire (Job Ref: WR/JOBS/22312-8812)

Job Ref : WR/JOBS/22312-8812
Discipline : Clinical Research/Clinical Research Associates
Contract : Permanent
Salary : £24,000-27,000 p.a.

Vacancy Location : Berkshire View Map

Job Description :

Job Summary

Flame Pharma Clinical Research – Senior Clinical Research Associate Job - Berkshire:

Flame Pharma is working with an international full service Clinical Research Organisation to recruit their full range of clinical opportunities. With a worldwide presence, and experience across a wide range of clinical therapeutic areas, our client can offer the career you are looking for. If you are looking for the career step from CRA or CRA II, then we want to hear from you regarding this exciting opportunity.

Working with the Clinical Project Director, Senior Clinical Project Manager, Senior Clinical Research Associate and Clinical Operations Coordinator, the Senior Clinical Research Associate will have full administration and full site responsibility for the clinical studies conducted at the organisation. There is opportunity to progress into line management for clinical research associates, and act as Clinical Lead or Clinical Project Manager on international studies.

Job Title

Senior Clinical Research Associate

Background

Key Responsibilities

• Acts as a member of the clinical project team with the goal to contribute towards efficient management of international clinical 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 clinical 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 clinical data collection methods to ensure collection of patient data is accurate, complete, and conforms to protocol requirements, in accordance with local regulations and ICHGCP guidelines
• Performs monitoring visits: ensures adherence to protocol, accurate clinical data collection via comprehensive source document verification, and investigational product/biological samples/supplies accountability.
• Performs data management review, including in-house CRF review, and alerts clinical project managers and clinical data managers to emerging issues with CRF completion.
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team.
• May write SAE narratives to support pharmacovigilance activities.
• Liaises with clinical data management to resolve clinical data discrepancies and ensure all clinical data management study goals are met.
• Prepares and performs closeout visits according to the protocol, local laws, ICH-GCP guidelines

Qualifications and Experience

• Proven relevant clinical research associate experience within the pharmaceutical industry or clinical research organisation.
• Knowledge of the clinical development process.
• Knowledge of ICH GCP.
• Experience of working in multi-disciplinary teams.
• Excellent Scandinavian and English language skills.

Benefits

With this position comes an attractive benefits package that you associate with a world leader, including pension, healthcare, plus a salary in the region of 24000-27000 plus bi-annual bonus scheme.

Key Words

Clinical Research Associate, Clinical Research Associate II, Senior Clinical Research Associate, CRA, SCRA, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

The position will be based in either Berkshire or Denmark.