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!