Senior Clinical Research Associate (Senior CRA)
We're currently partnering with a leading international pharmaceutical company to recruit a Senior Clinica Reasearch Assocaite.
Location: West London
Hybrid: twice a week in office
Job Summary
* Feasibility assessments/ visit evaluations for clinical trials.
* Site setup for commercial distribution and for clinical trials
* Study management
* Site management investigating, following up and escalating site issues as needed.
* Conduct remote and on-site visits in accordance with the protocols, GxP guidelines, applicable local and international regulations and company SOPs to ensure subjects rights, well-being and data reliability, ensuring audit readiness.
* Relationship management with site staff
* Assistance with pharmacovigilance, safety reporting management
* In house/ onsite document quality management
Responsabilties
Include, but are not limited to:
* 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.
Interested in making a difference?
Apply now or reach out to learn more about this exciting opportunity!
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