Opportunity to join a Medical Device company approaching clinical stage for their promising and novel neuromodulation device technology that's on a mission to reduce pain in a non-invasive manner. With the chance to be a part of the experienced group of clinical professionals, this is for an experienced Clinical Trial Coordinator who wants to define processes and make sure the clinical studies run smoothly!
- Work closely with the the senior leadership to coordinate and manage multiple clinical trials for several medical technologies developed within the company for key clinical applications.
- Serve a critical role for the company as the main bridge between the company and each clinical site within the United States and across multiple countries abroad, in which the clinical data will be leveraged to seek regulatory approval and widespread clinical dissemination.
- Manage key activities of each clinical study together with the investigators at each site to keep milestones and timelines of each study on track.
- Collect and maintain required records of study activity, such as case report forms, device records, regulatory forms and data collection summaries.
- Oversee subject enrollment to ensure that informed consent is properly obtained and documented, and enrollment within studies are progressing forward successfully.
- Monitor study activities to ensure compliance with protocols and with all relevant local, state and federal regulatory and institutional polices.
- Collect and document adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
- Assist or guide site investigators on the eligibility of potential subjects through methods such as screening interviews, reviews of medical records, or discussions with physicians and nurses.
- 3 years' experience in coordinating or managing clinical studies; experience with medical device studies is desired.
- Bachelor's Degree in a Life Sciences discipline
- Ability to be onsite at the
- Experience with performing clinical studies in academic institutions and/or hospitals in the United States is required, with preference to those who have been involved with multi-site studies.
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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