Gilbert Meher are partnered with a rapidly growing, innovative Medical Device company in California, in their search for a Clinical Research Associate or Senior Clinical Research Associate.
Due to continued success, the company are looking to grow their Clinical Research team and looking for Associates at various levels.
The successful candidate will be responsible for coordinating clinical research activities, whilst supporting Project Managers and Monitors in pre-market clinical trials.
If you are interested in joining an entrepreneurial team, who are constantly striving to develop new technologies for the treatment of vascular diseases, then this could be a perfect fit.
- Liaising with site staff, monitors, vendors, and/or CROs to execute operational activities.
- Reviewing and preparing technical documentation for clinical trials, including study protocols, informed consents, case report forms, and study training documents.
- Reconciling site documentation, such as patient medical records and site regulatory documents.
- Coordinating clinical studies whilst ensuring compliance with the company’s Standard Operating Procedures, external regulations and GCP guidelines.
- Perform site selection and negotiate contracts where required.
- Participate in data review, investigator meetings and site initiation visits.
- Perform other duties as required by management.
- Bachelor’s degree in Life Sciences.
- 2 – 5 years clinical research experience, ideally within medical devices.
- Previous experience as in-house or field Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Clinical Trial Associate (CTA) or similar position.
- Proficient in MS Office (Word, Excel, Access, PowerPoint) and Adobe Acrobat.
- Experience using technologies such as Electronic Data Capture systems (OpenClinica, Fusion, BioClinica Express, Inform, Medidata Rave etc.).
- Eligibility to work in the U.S. and not require visa sponsorship.
- Clinical expertise in Neurovascular and Cardiovascular therapeutic areas.
- Field Monitor experience a plus.
- Clinical Trial Management System (CTMS) experience.
- Experience with audit inspections.
- Certified Clinical Research Associate (CCRA) certification.
- Experience with global regulations.
- 401(k) match.
- Medical, Dental and Vision.
- PTO over Christmas (in addition to normal holiday allowance).
- On site gym.
For more information about this role, please contact Abigail Prudhoe at firstname.lastname@example.org or call +44 782 550 2645.
Whilst we may not be able to respond personally to each applicant, we appreciate the time you have taken to consider and apply for a new role with us. If you have not heard from us within 4 weeks, then on this occasion your application has not been successful.