Get AI-powered advice on this job and more exclusive features. Direct message the job poster from EPM Scientific 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.
Senior level
- Seniority levelEntry level
Employment type
- Employment typeFull-time
Job function
- Job functionHealth Care Provider
Industries
- IndustriesMedical Practices
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Clinical Research Associate (CRA in City of Westminster employer: EPM Ltd.
EPM Ltd. is an excellent employer that values innovation and collaboration, providing a dynamic work environment in West London. With a competitive salary and benefits package, along with a flexible hybrid working model, employees are encouraged to grow professionally while contributing to impactful clinical programmes across Europe. The company fosters a culture of support and development, making it an ideal place for those seeking meaningful and rewarding careers in the life sciences sector.
