Clinical Research Associate; CRA

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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!

• Seniority level
  
  Entry level

• Employment type
  
  Full-time

• Job function
  
  Health Care Provider
• Industries Medical Practices

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