Clinical Research Assistant (32212)

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

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