Clinical Research Associate (CRA

We're currently partnering with a leading international pharmaceutical company to recruit a Junior CRA.

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/projects

WHAT'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!