Job Description:
Latest job information from EPM Scientific for the position of Clinical Research Associate (CRA. If the Clinical Research Associate (CRA vacancy in Slough, England matches your qualifications, please submit your latest application or CV directly through the updated Jobkos job portal.
Please note that applying for a job may not always be easy, as new candidates must meet certain qualifications and requirements set by the company. We hope the career opportunity at EPM Scientific for the position of Clinical Research Associate (CRA below matches your qualifications.
We're currently partnering with a leading international pharmaceutical company to recruit a Junior CRA.Location: West LondonHybrid: Twice a week in officeDESCRIPTION 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/projectsWHAT'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!
Job Info:
- Company: EPM Scientific
- Position: Clinical Research Associate (CRA
- Work Location: Slough, England
- Country: GB
How to Submit an Application:
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