Hobson Prior are looking for a Senior Clinical Research Associate to join a up and coming Clinical Research Organisation. You will be accountable for performing and coordinating all aspects of clinical monitoring and site management, ensuring that country and site targets are achieved, in compliance with ICH/GCP, TRI SOPs and all other applicable regulatory requirements.
- Accountable for collation of trial related documentation (site contracts, consent documents, letters of agreement, confidentiality agreements), for Ethics committee submissions and renewals.
- Performs and coordinate all aspects of the clinical monitoring and site management.
- Conduct study site initiation meetings.
- Track patient recruitment and report on site issues/strategies to increase patient accrual into the trial.
- First point of contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing studies.
- Supervise tracking of completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion.
- Ensure maintenance of project site files.
- Conducts remote monitoring and site visits - assessing protocol and regulatory compliance, and reporting conduct using applicable documentation.
- Ensure site staff are trained in TRI and protocol specific procedures and are ICH-GCP compliant.
- Report legal, compliance and ethical violations in a timely manner.
- Excellent interpersonal and organisation skills.
- Capability to work to high standards.
- Proven ability to contribute to the development of working practices.
- Flexible and effective communication and negotiation skills.
- Minimum of 5 + years CRA experience in clinical trials.
- Life science or other relevant degree.
- Ideally a strong understanding of cardiovascular disease and treatment.
- Experience of working in observational trials.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.