"Clinical Research Assistant"

Under direction, the Clinical Research Assistant assists in the administration, execution, and overall management of clinical research studies.

Job Responsibilities

• Coordinates clinical trials data management in compliance with federal regulations, GCP guidelines & internal policies. Ensures accurate & timely data compilation. Assists research team with facilitating enrollment, treatment & data collection of subjects.
• Generates study-specific tools to ensure protocol compliance.
• Assists in screening of potential subjects; registers eligible subjects with the sponsoring agency accordingly.
• Maintains complete research charts for assigned caseload of subjects. Completes all required case report forms and resolves all outstanding queries in timely manner.
• Preparing, coordinating, and processing research lab kits as required.
• Assists in coordinating protocol schedule of events.
• Reports all Adverse Events and Serious Adverse Events (SAEs) to Institutional Review Board and other agencies, as required.
• Functions as liaison with sponsoring agencies. Coordinates site visits and audits of clinical trials in conjunction with all pertinent staff, including: the monitor/auditor, the regulatory office, investigational pharmacy, and investigators.
• Maintains and disseminates accurate listing(s) of active and potential study subjects to participating investigators. Acts as a resource for detailed information on assigned protocols and other investigational research activities.
• Performs other job related duties as required.

Education

High School Diploma

Experience

Bachelor's degree is preferred. Previous related experience in a hospital, research, or university environment.

Knowledge, Skills and Abilities

• Demonstrated ability to multi-task and prioritize in a fast-paced environment.
• Demonstrated strong communication and interpersonal skills; demonstrated ability to interact with multiple constituencies and exercise 'people skills'.
• Demonstrated organizational skills and ability to pay close attention to detail.
• Demonstrated proficiency with MS Office Suite and database applications.

Licenses and Certifications

None specified.

Working Conditions/Physical Demands

Travel may be required.