Senior Clinical Research Associate (Senior CRA)

EPM Scientific are currently partnering with a leading international pharmaceutical company who are searching for a Senior Clinical Research Associate to join their organisation.

Responsibilities:

• Management of studies
• Site evaluation and setup for commercial distribution including site training
• 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, GVP and applicable regulations.
• Monitoring of data collection and pharmacovigilance/ safety reporting at the sites where a study is conducted
• Site setup, training, initiation, close-out and management (including monitoring) of studies
• Site management including site payment process and reconciliation
• Study/clinical trial status tracking, QC and progress update to team
• Prepare or Review of site visit reports
• Participation in investigator meetings and other meetings as necessary
• Attendance of, and representation at, conferences as applicable
• Contribution to other tasks such as creation of newsletters as directed
• Assist with inspections/audits as required
• Contribute to the preparation of the
• CSR/publications, informed consents, protocols, and guidelines, sharing ideas with study members
• Prepare documents such as informed consent, monitoring plans and study operating manual for studies.
• Assist in creating project specific training for more junior members and sites
• Takes initiative to identify areas for potential process improvements, bringing these to the attention of the Clinical Operations Manager
• Preparation of Literature
• Reviews and searches Senior Clinical Specialist
  Contribution to scientific discussions regarding therapeutic areas, treatments, study endpoints and investigational medicinal products.

Qualifications/Experience:

• Graduate qualifications in Biological Sciences, Nursing, Pharmacy or related discipline
• Post-graduate qualifications desirable
• At least 4 years proven experience as a CRA
• On-site experience
• Working knowledge of ICH GCP guidelines
• 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.

This is a hybrid opportunity - twice a week in their West London office 

Interested in making a difference?
Apply now or reach out to learn more about this exciting opportunity!