Senior Clinical Research Associate
2 semanas atrás
Company Overview
Barrington James is a prominent global pharmaceutical organization currently seeking a part-time Freelance Principal Clinical Research Associate for an extended project.
Role Overview
The Principal Clinical Research Associate (CRA) is essential in managing the oversight of clinical trial monitoring. Collaborating closely with the Clinical Project Manager and Clinical Trial Associate, you will support the clinical trial teams, ensuring the efficient and successful execution of studies. Your responsibilities will include monitoring trends, formulating strategies to achieve objectives, and guaranteeing compliance and data integrity at the study sites.
Key Responsibilities
Clinical Monitoring Oversight and Collaboration
- Assist in the identification and selection of Investigators and study sites.
- Engage in study management meetings and coordinate monitoring activities.
- Identify and address monitoring challenges, reporting trends to the study team.
- Contribute to essential study documents, including monitoring plans, CRFs, and consent forms.
- Review the Trial Master File (TMF) for completeness and support audits and inspections.
Oversight of CRO Clinical Monitoring
- Plan and execute monitoring oversight visits to ensure compliance with study protocols.
- Ensure CRO CRAs receive adequate training and provide additional support as required.
- Monitor CRO performance, assist study sites, and foster relationships with site personnel.
- Review monitoring reports, track compliance, and escalate issues as necessary.
- Ensure site documentation is complete and prepared for inspection.
- Participate in discussions with CRO CRAs to remain informed about site performance.
Qualifications
- Bachelor's degree in life sciences or a related discipline; further training in clinical trials is advantageous.
- A minimum of 5 years of clinical monitoring experience, including 4 years in field monitoring.
- Experience with site selection, initiation, and close-out visits across various regions.
- Experience in the biotech sector is beneficial.
- Experience in overseeing CROs and mentoring CRAs is preferred.
Skills and Abilities
- Comprehensive understanding of clinical trial regulations (ICH GCP, FDA/EMA).
- Exceptional communication and organizational skills.
- Ability to manage multiple tasks in a fast-paced environment.
- Fluency in English; proficiency in additional European languages is a plus.
- Willingness to travel up to 40%.
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