Job Description

Function: The position trains with other clinical research staff and works directly with physicians to conduct clinical research trials, recruit and consent subjects, and collect and verify accuracy of data. The incumbent also assists in designing clinical trials and skill operationalizing a clinical trial in a clinical study; conducts human subject research involving multiple study sites; ensures IRB compliance; and provides communication to the Principal Investigator. 

Principal Duties & Responsibilities:

• Assist in data management, regulatory paper works and other local administrative tasks as supervised by the clinical research coordinator
• Coordinate research and administrative activities, ensuring all projects are completed according to project/study timelines
• Assist in the development of project/study policies and procedures. Administer policies and procedures according to protocol, Institutional Review Board (IRB), grant/contract and study and site specifications
• Recruit study participants and complete structured clinical assessments with participants
• Monitor and promptly respond to participant queries
• Collect and track study data and compile data reports
• Submit and maintain proper study records, including submission of timely reports to Institutional Review Boards
• Produce special and recurring reports

Other Duties as Assigned: 

The above information on this portion is designed to present the most essential duties and responsibilities necessary to achieve the positions end results. The occupant of this position is required to follow any other job-related instructions and perform any other duties as requested by Physician Director(s), Clinical Research Manager, and/or Practice Manager. It is the responsibility of each employee to assist other office staff when and where necessary. All employees have the responsibility of answering phones, maintaining files, filing, updating data, and receiving prescription refill orders, etc. Most importantly, it is each staff member’s responsibility to project and maintain a positive attitude toward all patients and fellow co- workers. The duties listed may be changed or modified at any time.

Qualifications

• Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors
• Knowledge of medical terminology
• Knowledge of good clinical practice, FDA, OHRP, HIPAA policies
• Familiarity with the Microsoft Office Suite
• Previous work with CRFs and EDC
• Excellent organizational skills to independently manage work flow
• Ability to prioritize quickly and appropriately
• Ability to multi-task
• Meticulous attention to detail

Education and Experience:

• Licensed candidates must have an Associate's degree and RN or LPN licensure
• One year of experience working in clinical research is preferred
• Psychology background preferred