support clinical study activities. This may include the coordination of internal clinical studies, clinical documentation maintenance, compilation and shipping of required study supplies and management of internal biological sample inventories.
Essential Duties and Responsibilities
- Assist in the generation, receipt and filing of required study documentation, including but not limited to study logs, study binders, and regulatory documents according to applicable SOPs.
- Assist with screening potential study sites, coordinating site questionnaires, and compiling site data for review by the clinical study lead or designee.
- Prepare and send CDAs, and other study related materials to clinical study sites.
- Follow up on regulatory approval status.
- Coordinate compliant shipments of samples, investigational devices and other applicable study supplies.
- Inventory, ship, track and log all supplies and devices in support of clinical studies.
- Inventory the receipt of biological samples and populate a database to track the disposition of samples.
- Coordinate in-house blood draws and internal sample collection studies.
- Maintain internal sample study administration
- Maintain clinical study activities in spreadsheet templates,
- BA/BS (chemistry, biology or other science preferred)
- 1-3 years’ experience in clinical study support and/or in biotechnology or related industry preferred