PS Clinical Research Coord

The University of Utah•Salt Lake, UT

31d

About The Position

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. Partnerships with individuals, communities, and many other entities are crucial to our work. Huntsman Cancer Institute values cancer-related health equity and inclusion as integral to our guiding principle to serve our patients and their communities, and our commitment to foster a culture of belonging for all within our organization. In your cover letter or during your interview process, we invite you to share how your personal and 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. Learn more: https://healthcare.utah.edu/huntsmancancerinstitute/about-us/equity-diversity-inclusion

Requirements

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

Nice To Haves

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.

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.