Assists investigators and/or other study staff in the implementation, coordination and conduct of clinical research activities.
1. Performs administrative tasks to support investigators and research team (copying, filing, etc.).
2. Assists with study start-up and the preparation and maintenance of all regulatory documents required by sponsor and/or regulatory agencies.
3. Assists in scheduling study visits as per the protocol, in coordination with the PI and/or study team, and research support services as applicable (pharmacy, lab, medical imaging, etc.).
4. Notifies research support services in advance of study visits.
5. Prepares supplies for study visits (consent forms, data collection materials, lab kits, etc.)
6. Assists in the collection of data and/or specimens from research participants and/or medical records, as appropriately trained/authorized.
7. Assists with data entry and management/updates of database.
8. Ensures participants are given a copy of the signed consent documents and copies are sent to HIM for medical records.
9. Maintains inventory and orders necessary supplies.
10. May escort participants and/or specimens to ancillary testing, procedures, etc.
11. Provides assistance in the conduct of site visits/audits by the sponsor or regulatory agencies.
12. Participates in continuing education (i.e., meetings, seminars and other activities) as deemed appropriate.
13. Respects patient rights and protects the confidentiality of patient and center information
14. Performs job functions adhering to service principles with customer service focus of innovation, service excellence and teamwork to provide the highest quality care and service to our patients, families, co-workers and others.
1. High School diploma required. College degree in related discipline preferred.
2. Prior experience and/or training in clinical research and human subjects protection preferred.
3. Strong organizational and communication skills.
4. Ability to work collaboratively with a diverse range of individuals.
5. Working knowledge of Microsoft Office Suite (Word, Excel, Outlook, etc.)