Midlands CRA / homebased / UK
- Experience Level
- Experienced (non-manager)
Midlands CRA / Regionalised monitoring
DOCS is recruiting passionate Clinical Research Associates / CRAs who can demonstrate external clinical site monitoring experience gained on phase II and III clinical trials within CRO, biotech and/or pharmaceutical company work settings.
Role and responsibilities
The successful candidate will perform site pre-qualification/identification, site initiation, study start-up, external routine site monitoring/site management and/or closeout activities.
- Assess potential investigators and decide on the suitability of the site
- If required, conduct one or more pre-trial visits to assess the investigational staff and facilities
- Discuss the items listed with the investigator and other appropriate staff
- Review the site commitment in detail with the investigator
- Develop/adapt recruitment and retention strategy for the site
- Ensure that the current versions of the trial documents that are listed on the Site Initiation Report and all required trial-related materials and supplies are provided to the investigational site
- Ensure that the investigators send the SUA gap pack to the IEC/IRB, when the sponsor is not responsible for sending safety information to the IEC/IRB
- Set up the IF and TCF
- If applicable, coordinate development of site-specific ICF
- Ensure that the investigational staff are instructed on the requirements for proper informed consent
- When local Ethics Committees are used, ensure that the IEC/IRB is provided with current and complete copies of all documents that the IEC/IRB requests to fulfil its obligation and obtain a copy of the valid written IEC/IRB approval and all related required documents, including the composition of the IEC/IRB
- Obtain site related trial documents and review them for completeness and accuracy
- Negotiate investigator budgets at site level and track the status of site CTA
- Plan and conduct investigator and site-staff training
- Conduct site initiation visits, etc.
- Notify the relevant parties writing, when a country and an investigational site is approved to receive clinical drug supplies
- At the investigational site, ensure clinical drug supplies are available, appropriately used, handled, stored (for ex., temperature logs, security), and returned, accurately inventoried and documented. Inform the investigational staff of the distribution process
- Follow up with the trial site regarding case report forms and data correction forms
- Conduct monitoring visits according to the checklist of activities listed on the Monitoring Visit Report
- Ensure that all AEs/SAEs/PQCs are reported within reporting timelines and documented as appropriate. For AEs/SAEs ensure they are consistent with all data collected and with the information in the source documents*
- Ensure that the investigators send the safety reports to the IEC/IRB, when the sponsor is not responsible for sending safety information to the IEC/IRB
- Arrange for the appropriate destruction of clinical drug supplies
- Ensure that the investigational staff stores the randomization codes in a limited access area that is accessible 24 hours a day and instruct them on the code-breaking procedure
- In studies where IVRS is used: Ensure that the IVRS at the site has been activated and tested and that unblinding capabilities are operational for those authorized to unblind subjects
- Track costs at site level & ensure payments are made
- Ensure TCF is maintained as required and maintain IF
- Ensure subject commitment per site is met
- Conduct site closure visit according to the checklist activities listed on the site closure report
- Arrange for final payment(s)
- If applicable, remind the investigator to notify the IEC/IRB of the site closure
- Ensure the IF is complete and accurate
- Provide study report synopsis to investigators, IEC/IRBs
- Follow up on and resolve any pending issues, including adverse events one year post-trial
What is required
- BA/BS degree is required or a nursing qualification. A degree in a health or science is preferred.
- Recent UK-based CRA experience working on commercial phase II/III clinical trials
- Proven track-record of working effectively in fast-paced environments and handling complex workloads
- Excellent cross-functional relationship building skills
- Full and valid UK working eligibility
- Full clean driving licence with easy access to main motorways and willingness to drive to sites 2 to 3 times per week on average
- Start date: negotiable for the right candidate
What is offered
- Permanent and full time contract of employment with DOCS seconded to our client
- Structured on-boarding for all new joiners
- Salary will depend on level of experience and skills
- Company benefits to include 23 days holiday, car allowance, and more.
- Great scope to develop your career further
Please send your application* with most recent CV today to find out more about this fantastic career opportunity to me.
*Applicants who have not had a response within two weeks should assume their application has been unsuccessful.