Clinical Trial Assistant - Permanent - New Jersey
Clintec is currently looking to hire a Clinical Trial Assistant to work at our client's site in Woodcliff Lake, New Jersey on a full time, permanent basis. Apply now to become part of our global team!
The Clinical Trial Assistant (CTA) will support the clinical team in the following areas: accurately update and maintain clinical systems and/or trackers within project timelines; prepare, handle, distribute, file, and archive clinical documentation and reports; review of study files periodically for accuracy and completeness. Work will be completed under moderate supervision. Routine work may require little to no instruction.
Supports all phases of clinical study activities (feasibility, start-up, maintenance, and close-out).
Assist with filing and archiving project documentation in the eTMF within 20 day timeframe.
Assist with creating, updating and maintaining project trackers in EPIC.
Assist with creating, updating and maintaining timelines in EMMI.
Assist with monitoring visit report review in order to maintain oversight of clinical monitoring quality and adherence to protocol, and established processes and plans.
Provides support for document preparation (e.g, Informed Consent Form, TMF Filing Plan, Co-Monitoring Plan).
Attend internal study team meetings, and prepare and distribute study team agendas and minutes.
Attend CRO teleconferences/meetings when applicable.
Track clinical trial site agreements and upload to EPIC project space.
Prepare requests for clinical trial insurance.
Review regulatory packet for initial investigational product release.
Assist with investigator meeting planning meetings, including entering clinical meetings into the HEAT system and EMMI.
Attend investigator meeting when applicable.
Track and manage all study vendor invoices.
Act as a central point-of-contact for the clinical team for designated project communications, correspondence and associated documentation.
Completes work within set time frames.
Other duties as assigned.
Experience & Qualifications:
Associate Degree or Higher
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.