Description

Bachelor's Degree in a Health Sciences or related field and at least two (2) years of Clinical Research experience.  Master's Degree preferred.

Certifications, Licenses or Registration Required:  Certified Clinical Research Coordinator (CCRC) preferred.

Additional Job Description

Excellent knowledge of good clinical practice and FDA regulations.  Superior oral and written communication skills.  Strong interpersonal skills to effectively interact with patients, physicians, staff, and study sponsors.  Knowledge and understanding of computer systems, tools, and programs.  Ability to assume a leadership role in a team environment.  Working knowledge of IRB submissions/amendments, patient screening and consenting.  Excellent organizational skills.

Requirements

Responsibilities

Assumes responsibility for all aspects of study recruitment, screening, enrollment, and visits for eligible participants.  Administers study-related procedures & instruments; directs participants for hospital and physician procedures.
Ensures that research personnel are knowledgeable about all components of the study protocol and that staff roles and responsibilities are delineated.
Oversees and manages scheduling, documentation, and follow-ups with research participants.  Supervises patient education and referrals.
Monitors study budgets and billings to ensure adequacy of funds and compliance with UMMC policies and federal regulations.
Corresponds with study investigators, sponsors, regulatory agencies, and UMMC compliance personnel on matters related to study documentation, records, data and operations.
Prepares IRB documents and progress reports.  Oversees maintenance of regulatory documents, files, and reports.
The duties listed are general in nature and are examples of the duties and responsibilities performed and are not meant to be construed as exclusive or all-inclusive. Management retains the right to add or change duties at any time.