Clinical Research Coordinators

Huntsman Cancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve – which includes Idaho, Montana, Nevada, Utah, and Wyoming – with impact worldwide. In your cover letter or during your interview process, we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities.

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 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.

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 counsel from the Principal Investigator as necessary.

The incumbent is expected to closely monitor the use of experimental equipment and drugs. Because some subjects referred to participate in a research study have no other option for recovery, the incumbent must be aware of the subject's condition, well-informed in the use of study material (devices, equipment, etc.), and conscientious in their analysis of appropriate actions. The incumbent is responsible for organizing coverage when not present to ensure protocol requirements are followed.

Work Environment

• Nearly Continuously: Office environment, hearing, listening, talking.
• Often: Repetitive hand motion (such as typing), walking, standing, sitting.
• Seldom: Infectious disease, oils (air or skin exposure), bending, reaching overhead.

Physical Requirements

The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on their assigned unit. The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patient's status and provide care as described in the department's policies and procedures manual.

This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers, and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.

Requirements

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).

• 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

• Bachelor's degree in a health sciences or related field or equivalency (one year of education can be substituted for two years of related work experience) with two years of 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.
• Knowledge of Good Clinical Practices, FDA, HIPAA, and IRB regulations; an understanding of research procedures; and the ability to function independently.
• Departments may require IRB CITI Course or IATA DGR training within a specified timeframe.
• Departments may prefer a nursing degree for this position, including two years of related experience and possession of a nationally recognized research compliance certification.

Pay

$29,913 to $68,625

Full-time position.