Clinical Research Associate (CRA

London Full-Time 30000 - 42000 £ / year (est.) No home office possible

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Consultant at EPM Scientific | Permanent Solutions 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 Seniority level Entry level
Employment type Employment type Full-time
Job function Job function Health Care Provider
Industries Medical Practices
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