Clinical Research Physician
5 days ago
About Us
We're a dedicated team of experts driven by our passion for improving patients' lives. Our mission is to advance medicine through innovative solutions, delivered with integrity.
Our Expertise:
We specialize in delivering comprehensive clinical development solutions for small and mid-size drug developers. Our experts leverage wide therapeutic experience and specialist expertise to execute a diverse portfolio of trials. We're agile, responsive, and perfectly structured to provide full-service clinical development solutions.
The Role
We're seeking an Associate Medical Director to join our Medical-Clinical Pharmacology team. As an Associate Medical Director, you'll be responsible for ensuring the safety and welfare of trial participants, delivering high-quality studies, and ensuring all procedures are performed to acceptable medical, scientific, and ethical standards.
You'll be responsible for line management of the Research Physician team, sharing their knowledge, and supporting their competency. You'll also act as Principal Investigator on studies, including First-in-Human Trials.
Key Accountabilities:
- Ensure the safety and welfare of trial participants and the delivery of high-quality studies in the Clinical Pharmacology Unit, in accordance with our Quality Management System, ICH-GCP, and MHRA Phase I accreditation requirements.
- Assess and develop key trial documents and reports, including study protocols, Risk Management Plans, study-specific training, and safety reports.
- Perform screening, ongoing monitoring, and post-study clinical examinations, reporting any clinically significant abnormal results and/or changes from baseline, and taking action accordingly.
- Evaluate participants' eligibility and obtain written informed consent for inclusion in a specific study.
- Support effective communication with volunteers' General Practitioners regarding their participation in a study, collaborative care, and follow-up.
- Act as Principal Investigator (including First-in-Human) / Sub-Investigator for clinical trials, actively participating in data review and taking responsibility for trial decisions, and liaison with hospital specialists, GPs, consultants, and others to recruit suitable volunteers and patients for clinical trials.
- Be proficient in Advanced Life Support and capable of dealing with acute medical emergencies that may arise in the Clinic Pharmacy Unit. Provide medical cover outside of normal working hours as part of an On-Call Rota.
- Line Management of Research Physicians and provide leadership support and guidance to the Heads of Departments for the Clinic and Enrolment Services departments to fulfill their roles successfully.
- Participate in Commercial Development activities, including Feasibility assessment and Budget reviews when required, and take an active role in providing feasibility and strategic advice for proposal development at key client meetings and Bid Defence Meetings.
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