Senior Clinical Research Associate
Proclinical is excited to announce a new vacancy for a home-based Senior CRA role in the United Kingdom. This is a great chance to join a passionate, innovative and committed team and make some positive contributions to medicine.
- Full ownership of investigator sites for assigned studies, with responsibility for the successful management of the site right through to close-out, in accordance with the clinical monitoring plan.
- Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and working diligently to relevant guidelines.
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
- Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Assesses site processes, Conducts Source Document Review of appropriate site source documents and medical records
- May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
Skills and Requirements
- Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment is essential.
- A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
- You will be educated to degree level in a life science discipline or be a licensed healthcare professional.
- Experience working on Oncology trials or complex studies would be an advantage for this role.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Reem Iskandarani on 02038542629 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.