Clinical Research Assistant (32611)

- Read and understand specific requirements of each study protocol and informed consent form
- Works with study coordinators and other research team members to complete protocol specific procedures and documentation
- Assists in clinic and protocol administration duties including but not limited to:

- Explain the purpose, risks, and benefits of clinical trial participation
- Screen potential candidates in a timely and accurate manner
- Ensure that study patients understand the information presented and agree to the protocol requirements
- Obtain and maintain consent of patients prior to any study-related procedures being performed and with the highest ethical standards
- Provide instructions to patients to ensure proper protocol compliance
- Distribute study medications in compliance with protocol randomization requirements
- Learn and understand lab procedures and obtain and process study related lab specimens according to the study specific manuals (lab and procedural)
- Use approved source documents; obtain protocol-specific data to complete and maintain source documents and case report forms (including electronic data capture – EDC) in accordance with applicable regulations and sponsor requirements








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- Perform study-specific readings and measurements including but not limited to:

- Vital signs
- ECG
- Urine Pregnancy Test
- Uroflow, TRUS, urinalysis, cystoscopy
- Photography and videography
- Reports irregular readings and measurements to Investigator and Lead Study Coordinator
- Package and ship laboratory specimens to study-specific destinations
- Complete applicable training requirements and ongoing education as required
- Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc.
- Communicate with and support patients and their families as necessary.
- Work with the EMR and data management systems to complete EDC, eCRFs, find patients, maintain records
- Effectively communicate with potential candidates for trials and collect metrics to track progress
- Must have or gain knowledge of relevant software/programs
- Work closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings and calls
- Assist with the development of source documents and phone screen tools
- Manage ancillary supply inventory and assist with drug accountability
- Maintain HIPAA compliant communication and confidentiality, at all times
- Participate in site visits (site initiation visits, interim monitoring visits, close-out visits, etc.
- Assist study coordinators with necessary study close-out procedures and documentation
- Performs other duties as assigned