Job Description

Job Summary
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.

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. This may include description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute’s mission and this position.
Responsibilities
Essential Functions
Oversees administrative matters regarding the day-to-day operations and procedures of a research administrative program.
Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies. Prepares or assists in preparing audit reports, IRB documents, and protocols.
Recognizes, tracks and reports adverse events and protocol deviations.
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
Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.
Supervises, mentors and trains new or junior research staff, may supervise subordinate 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/or documentation of procedures followed.
Assists Principal Investigators 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 council from the Principal Investigator as necessary.

The incumbent is expected to closely monitor use of experimental protocols.

The incumbent is responsible to organize coverage when not present to ensure protocol requirements are followed.

This job description is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Work Environment and Level of Frequency that may be required:
Nearly Continuously: Office environment.
Seldom: Infectious disease, oils (there is air or skin exposure to oils or other cutting fluids).

Physical Requirements and Level of Frequency that may be required
Nearly Continuously: Hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking, standing, sitting.
Seldom: Bending, reaching overhead.
Minimum Qualifications
Bachelors 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 professional research experience and completion of University RATS Clinical Certification within one year of hire required. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required.

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.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.