Clinical Research Associate - Uxbridge
Lucy Stendall is recruiting for a freelance CRA to join a global biopharmaceutical company working field based UK wide, reporting to the company's office in Uxbridge on a 12 month contract.
The main purpose of the role will be to
- Monitor assigned clinical sites and ensure compliance of assigned studies with national and international regulatory requirements.
- Conduct pre-study, initiation, interim monitoring and close-out visits.
- Train assigned investigative sites in GCP and assure these sites are conducting research according to protocol and national laws.
- Review investigative sites' regulatory documentation and ensure compliance with GCP.
- Monitor informed consent process.
- Serve as main point of contact with assigned investigative sites.
- Review and update clinical files at assigned investigative sites.
- Initiate actions to ensure all assigned investigative sites are in compliance with protocol and GCP.
- Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of what happened to a subject while participating in the study.
- Create and properly file trip reports, follow-up letters and telephone contacts for assigned investigative sites
- Evaluate and Resolve Data Queries.
- Evaluate study query trends and interact with study team in improving data quality.
- Assist investigative site with the timely and accurate resolution of queries.
- Attend, participate and present at investigator meetings, as requested.
- Effectively negotiate and manage clinical study budgets for assigned investigative sites.
- Act as a liaison between the company and assigned investigative sites
- Identify new investigators for the company's future studies.
- Assist in the review of draft Case Report Forms and Protocols, as requested.
- Participate in study and clinical team meetings. Communicate clinical performance data to other members of the management and scientific team.
- Assist in mentoring new CRAs, as requested.
- Involved in affiliate CRO oversight activities as directed by CRM or CRD.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- University Degree (life science) or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing certification, medical or laboratory technology)
- Relevant clinical research and monitoring experience in pharmaceutical or CRO industries
- Previous oncology experience would be preferable
- Prior early phase monitoring experience
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
- A willingness to travel approximately 80% site monitoring including travel with possible overnight stays.
For more information or to apply for this position, please contact Lucy Stendall on 01246 457733 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL39270 in all correspondence.