Contract Clinical Research Associate, IDE Endocrinology
We’re actively seeking an experienced, contract Clinical Research Associate (CRA) with endocrinology monitoring experience gained while working for a CRO or Sponsor, to support an investigator-initiated device study for a world-renowned academic medical center in the Northeast. This is a fully remote monitoring role at approximately 10% utilization (about 5-6 hours per month on average), with the work concentrated around three remote monitoring visits, possibly four if a for-cause visit is needed, over about 11 months. It’s ideal for an independent CRA who enjoys working with minimal oversight and wants a small assignment alongside their current work. Our client is looking to fill this role by early November. We’re seeking CRAs who have a minimum of 5 years of recent experience as a fully dedicated regional/home-based field monitor for a CRO or pharma, at least 1 year of experience monitoring studies where a device delivers the drug, at least 1 year of experience monitoring studies conducted under an Investigational Device Exemption (IDE), and at least 1 year of Endocrinology monitoring experience. Candidates should be located in the Eastern or Central time zone and able to work Eastern hours. Experience with Diabetes device or drug delivery pump studies, Automated Insulin Delivery, investigator-initiated studies, or studies involving pregnant women is a plus. Apply below if this is you!
- Act as the "Site Manager" ensuring relationship with site(s) are positive, issues are resolved quickly, and communications are strong across all verticals.
- Assist with the development of study manuals, CRFs, monitoring standards, site study tools and other study materials as required.
- Develop and implement site recruitment, selection and initiation plan.
- Manage and drive patient recruitment and enrollment tracking.
- Provide training to sites on the study protocol, study conduct, CRF completion and data management expectations.
- Ensure essential document collection for completeness per regulatory requirements.
- Serve as a liaison with Investigators, Institutions and sites to provide support during the conduct of the clinical trial and serve as a resource for protocol and procedures.
- Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs.
Manage one or multiple studies. - Monitor product supplies/accountability including proper storage, dispensation, and disposal.
- Manage study completion activities including CRF collection, query resolution, record archiving and site closeout activities.
- Review in-house data and study tables.
- Mentor, coach and provide guidance to clinical staff as appropriate.
- Supervise and train other employees as appropriate.
- Minimum of 5 years of recent experience as a fully dedicated regional/home-based field monitor for a CRO or pharma, working in that role within the last 2 years
- At least 1 year of experience monitoring studies where a device delivers the drug
- At least 1 year of experience monitoring studies conducted under an Investigational Device Exemption (IDE)
- At least 1 year of experience monitoring Endocrinology studies
- Nice to have: experience monitoring Diabetes device or drug delivery pump studies, Automated Insulin Delivery studies, investigator-initiated studies, or studies involving pregnant women
- Located in the Eastern or Central time zone and able to work Eastern hours
- Available for approximately 10% utilization, fully remote