Clinical Research Coordinator

About the role

Coordinates the implementation, quality control and completion of research studies while assisting the Principal Investigator in determining and accomplishing study objectives. Oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies. This position is patient-sensitive and must fulfill all associated requirements.

Responsibilities

• Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.
• Develops study budgets; monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services.
• Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance.
• Coordinates and performs responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study-related parties.
• Recognizes, tracks and reports adverse events and protocol deviations.
• Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.
• Represents the research program at meetings, national and international research consortia.
• Prepares, submits and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence.
• Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
• Supervises, mentors and trains new or junior research staff.
• Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
• Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
• Assists the Principal Investigator in the development of study protocols.

Clinical Research Coordinator (Non-R.N.), II

• Coordinate day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations.
• Implement processes and organize efforts within study team to achieve objectives, coordinating research procedures, study visits, and follow-up care.
• Create and maintain tools and documentation to track study metrics, providing updates to management.
• Conduct pre-study, site qualification, study initiation, monitoring visits, and close-out activities.
• Maintain source documents and report adverse events.
• Recruit, screen, enroll, and obtain consent from study participants.
• Collect and maintain patient and laboratory data.
• Work directly with study participants and families and serve as project liaison to other departments, outside organizations, and government agencies.
• Works under the direction of the Primary Investigator (PI).
• Requires moderate skill set and proficiency in discipline. Conducts work assignments of increasing complexity, under moderate supervision with some latitude for independent judgment.

Problem Solving

The incumbent decides how to best accomplish the daily requirements of various study objectives, prioritizes and delegates workload and establishes systems needed to achieve specific study goals. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow through and compliance of all involved. The incumbent functions independently under minimal supervision, following FDA, Good Clinical Practice, IRB, NIH, NCI, NSF and/or other regulatory agency guidelines and seeking council from the Principal Investigator as necessary. The incumbent is expected to closely monitor use of experimental equipment and drugs. Because some subjects referred to participate on a research study have no other option for recovery, the incumbent must be aware of the subjects condition, well informed in the use of study material (devices, equipment, etc.) and conscientious in his/her analysis of appropriate actions. The incumbent is responsible to organize coverage when not present to ensure protocol requirements are followed.

Minimum Qualifications

EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor's degree = 4 years of directly related work experience). Department may hire employee at one of the following job levels: Clinical Research Coordinator (Non-R.N.), II: Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience.

Preferences

• Bachelors degree in a health science or related field or equivalency; plus, two years professional research experience and completion of University RATS Clinical Certification within one year of hire.
• Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also preferred.
• Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred.
• Departments may require IRB CITI Course or IATA DGR training within a specified timeframe.
• Departments may prefer a nursing degree for this position, which requires the incumbent to have two years related experience and possess a nationally recognized research compliance certification.