Job Title

We're currently partnering with a leading international pharmaceutical company to recruit a Junior CRA.Applying for this role is straight forward Scroll down and click on Apply to be considered for this position.Location: West London Hybrid: Twice a week in office DESCRIPTION OF THE ROLE Site evaluation and setup for commercial distribution including training of dosing in collaboration with the Clinical Project Manager or designee Maintenance of contacts with sites for commercial distribution and sites which may be involved in clinical trials Collection of essential documents according to ICH-GCP E6 (R2) and applicable regulations Monitoring of data collection and pharmacovigilance/ safety reporting at the sites where a post authorisation study is conducted Site setup, initiation, close-out and management (including monitoring) of sites participating in clinical and post-authorisation studies on an as needs basis Site management including site supplies, site payment process, etc. Study/clinical trial status tracking and progress update to team EC/IRB and regulatory submissions Participation in investigator meetings and other meetings as necessary Attendance of conferences as applicable Contribution to other tasks such as creation of newsletters as directed by the Clinical Project Manager or designee Assist with audits as required Contribute to initiatives and process improvements as required Contribute to Literature Reviews.KEY RESULT AREAS Feasibility assessments/visit evaluations for clinical and post-authorisation studies Site setup for commercial distribution according to post-authorisation requirements Site setup for clinical trials (as needs basis) Site management: investigating, following up and escalating site issues as needed. Delivery of data accuracy through CRF review through on-site and remote monitoring according to the risk-based monitoring plan to ensure patient safety, compliance and decreased risks. Assistance with pharmacovigilance, safety reporting management and investigations of quality complaints In-house/ on-site document quality management (including, but not limited to, trial master file, investigator site file).QUALIFICATIONS/EXPERIENCE Graduate qualifications in Biological Sciences, Nursing, Pharmacy or related discipline Post-graduate qualifications desirable At least 2 years proven experience as a CRA Working knowledge of ICH GCP guidelines On-site experience Proven experience in managing clinical trials/projectsWHAT'S ON OFFER A competitive salary with benefits. The chance to contribute and be part of team whose work directly benefits healthcare and strives to improve people's lives. A real hands-on opportunity to gain a high degree of commercial exposure. The chance to work alongside world-leading scientific experts. Working with highly-talented and dedicated colleagues in a fast-growing company that combines a focus on cutting-edge science with commercial delivery.Interested in making a difference? Apply now or reach out to learn more about this exciting opportunity!