Our client is a well-respected and established pharmaceutical company in West London, UK. They are currently looking for a Lead CRA to join their team.
- Oversight of external CRAs, and CTAs in the conduct of their dutiesTo supervise external CRAs, and CTAs in the conduct of their duties
- Supervise aspects of services provided by external partners and be responsible for (monitoring or) co-monitoring across a range of clinical studies (Phase I-IV).
- The SCRA must work closely with personnel including the company's in-house clinical project managers, quality assurance, regulatory affairs & programme management and other parts of the business in a matrix environment.
- The SCRA ensures appropriate planning, implementation, and tracking of the clinical monitoring process and also maintains an overview of the administration of clinical trials.
- The position requires an active role in ensuring the execution of the monitoring and applicable safety plans.
- To remotely coordinate, manage and support clinical monitoring activities in Europe, US and Rest of World (ROW), to include issue resolution, patient enrolment, contract amendments, drug supply etc.
- To become thoroughly familiar with the assigned study protocol and documentation & develop a co-monitoring plan to enable proper evaluation of CRA performance and facilitation of any training deemed appropriate during and after the conduct of the visit
- To represent the company during co-monitoring visits to include investigator & site interaction providing guidance to the CRA and necessary support for issue resolution
- To provide feedback and CAPA plans following co-monitoring visits to ensure the Project Manager has visibility of the study at a site level to inform decision
- To manage designated clinical trial activities, ensuring they are completed in a timely fashion in accordance with SOPs and applicable guidelines
- To participate in national and international meetings related to clinical trials with, for example, CRO staff, investigators and site staff
- To assist in the review of monitoring reports to ensure project-specific information to/from trial sites and documents communication with study site/ team and escalates issues to team in a timely manner.
- To compile and perform QC checks on GCP documentation required for the TMF
- A comprehensive understanding of the full clinical trial process, from protocol design, feasibility, studyset up, initiation, execution, data management and reporting
- Must have demonstrated problem-solving abilities in overseeing clinical sites, and demonstrated tactfulness and diplomacy in dealing with study coordinators and physicians
- Thorough knowledge of ICH/GCP as required for clinical trial activities
- Scientific ability to understand technical, scientific and medical background of a development project
- Experience working with, or within a CRO is required
- Degree in Life Science or Nursing Background
- Must be a holder of a UK driving license
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jonathan Senior on +44 203 8569 334 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.