Due to the continuing increase in client demand for the management and monitoring of GCP-compliant clinical studies, an exciting new opportunity has become available in the US. The position will start out on a contractual basis and progress to a full time staff position for the right candidate. A full benefits package is included. The incumbent will work out of a home office within the US (location flexible) and report to the Technical and Business Development Director for the US.
Key accountabilities of the position include:
- Perform all clinical monitoring/site management activities for assigned projects in accordance with Triveritas standard operating procedures and applicable veterinary clinical research regulatory requirements (VICH-GCP)
- Act as the primary contact for Triveritas with assigned clinical sites, and use judgment to assess and ensure overall integrity of study implementation, as well as adherence to study protocol
- Conduct qualification visits, site initiation visits, monitoring visits and study close-out visits at assigned clinical sites
- Manage all clinical monitoring activities including conducting and reporting site visits, performing drug accountability assessments, ensuring that regulatory documentation and reported data are complete and accurate, maintaining tracking spreadsheets, monitoring animal safety and reporting adverse events, as appropriate
The ideal candidate will have, at a minimum, a bachelor’s degree preferably in the animal or life sciences or other health related discipline. Associate degrees in veterinary technology will also be considered. Preference will be given to individuals with at least 1-2 years of experience monitoring GCP field trials (either in the human or animal sectors), and have a working knowledge of EDC systems. Other key competencies include a thorough knowledge of the VICH – GCP regulations and guidelines governing veterinary or human clinical studies, excellent organizational, time management, communication and computer skills and the ability to work well both independently, and in a team setting. Due to the remote nature of the job, it is vital that the incumbent maintains close ties and communicates frequently with members of the US team as well as with other colleagues based in the UK office. Travel within the US will be required and is expected to be approximately 40% with overnight stays included.
The successful candidate will benefit from the opportunity to advance their career in our friendly, growing company.
Applications, including a cover letter and CV, should be sent by email to Dr. Victoria Lewis at firstname.lastname@example.org and Mrs. Sue Lester at email@example.com.