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| JOBS OF THE WEEK |
Clinical Research Associate IISlough, NegotiableOur client is an international biopharmaceutical company seeking to deliver truly innovative and life-changing drugs for our patients. Their mission as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
They are offering an exciting career for a candidate with proven direct clinical study monitoring experience with a relevant scientific or nursing degree.
Responsibilities include:.
1. Monitor assigned investigative sites
• Plan and conduct pre-study, initiation, interim monitoring and close-out visits
• Train assigned investigative sites in GCP/ICH and ensure these sites are conducting research according to protocol and regulations
• Review investigative sites’ regulatory documentation and ensure compliance with GCP/ICH
• Monitor compliance with protocol, informed consent process, drug accountability, GCP/ICH and applicable local laws
• Serve as main point of contact with assigned investigative sites
• Review and train sites in updating clinical files in compliance with GCP/ICH
• Initiate actions to ensure all assigned investigative sites are in compliance with protocol and GCP /ICH
• 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
• Organize delivery of supplies (e.g. study medication, lab kits, CRFs) as required
• Monitor inclusion rate and discuss action plan to ensure completion of the study within planned timelines
• Create and properly file trip reports, follow-up letters and telephone contacts for assigned investigative sites
2. Evaluate and Resolve Data Queries
• Evaluate study query trends and interact with Study Team in improving data quality
• Work with Data Management and assist investigative sites to achieve timely and accurate resolution of queries
3. Attend, participate and present at Investigator meetings
4. Effectively negotiate and manage clinical study budgets and contracts for assigned sites
5. Act as a liaison between our client and assigned investigative sites
6. Identify new investigators for future studies undertaken by our client
7. Assist in Review draft CRF and provide feedback as required
8. Participate in study team meetings
9. Assist in mentoring new CRAs, as requested
10. Assist IRB/IEC-submissions / correspondence e.g.
• Compile submission dossier in consultation with the investigator
• Adapt patient information and consent form to local regulatory requirements to ensure approval
• Ensure translation and back translation of study specific documents as required
• Send annual reports to IRBs / IECs as required
• Update submissions, e.g. protocol amendments, safety reports
• Notify IRBs / IECs about study completion / termination
11. Up to approximately 80% domestic travel required, including overnight stays
12. Comply with Our client’s travel policy
Skills/Knowledge Required:
• Prior experience as a Clinical Research Associate
• Must have demonstrated problem-solving abilities in overseeing clinical sites, and demonstrated tactfulness and diplomacy in dealing with study coordinators and physicians
• Experience in study / site set up
• Able to resolve routine issues independently
• Knowledge of regulatory environment (ICH, GCP, EU CT Directive, local laws)
• Excellent written and oral communication skills
• Fluent written and spoken English
• Working knowledge of SOPs relevant to clinical research
• Current, clean driver’s license
Skills/Knowledge Preferred:
• Prior haematology / oncology clinical study experience
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