Clinical Research Associate (CRA

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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 LondonHybrid: 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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