Clinical Trials Research Coordinator II
*If interested, please apply directly by sending your resume to Callie Olson at [ Email address blocked ] - Click here to apply to Admin Clerical-Subject Matter Expert-Contractor*
STRONG CLINICAL TRIALS EXPERIENCE NEEDED.
- Maintain the security and confidentiality of participants' paper or electronic data (e.g., case report forms kept in a secure, locked space).
- Direct issues requiring medical decision-making to the appropriate licensed staff member promptly.
- According to protocol and/or IRB-approved telephone script, collect and document research data and report the information to the appropriate licensed staff member and PI for assessment in a timely manner.
- Coordinate and schedule participants for study assessments/visits, required tests, including visit specific lab kits and/or paperwork preparation, etc.
- Prepare packets for participants (e.g., instructions, phone numbers, calendars, diaries, etc.).
- With appropriate guidance, obtain and review medical records and test results of all project/study participants and abstract needed data per protocol requirements.
- With guidance from PI, complete case report forms (paper or electronic) and maintain a database program to track all study activity including study enrollment and consents.
- Respond to Sponsor to resolve data queries and delinquencies in a timely manner.
- Report any potential protocol violations/deviations to the PI in a timely manner.
- Assist in the collection of protocol-required data with timely and accurate submissions as required by Sponsor (e.g., weekly screening log, routine electronic data submissions).
- Coordinate and prepare protocol specimens for shipping or storage in accordance with IATA/DOT regulations and Sponsor shipping guidelines.
- Assist with participant's long-term follow-up data collection.
- Assist PI and/or Clinical Trial Nurse, if applicable, with identifying, screening, and recruiting potential participants.
- Provide PI and/or Clinical Trial Nurse with the ongoing informed consent process by coordinating the current consent documents.
- Assist in study closure activities including preparation and collection of close-out documentation, and preparation of study files for distribution to long-term storage.
- With guidance, receive, disseminate and maintain study-related communications with internal and external parties involved with clinical trial protocols.
- Ensure that study-related, non-test article supplies are shipped and re-supplied according to protocol, including tracking expiration dates.
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