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Clinical Research Coord

Employer
University of Utah
Location
Utah, United States
Salary
Salary Not specified
Date posted
Jan 4, 2025
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Clinical Research Coord

Job Summary

The Population Sciences Trials Office at the Huntsman Cancer Institute has an immediate opening for a Clinical Research Coordinator. The coordinator will assist the Principal Investigator(s) in coordinating 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 work may include supporting investigator-initiated studies and sponsored projects.

The Population Sciences Trials Office (PSTO) supports Investigators conducting observational and behavioral intervention studies aimed at preventing cancer in different populations and/or at improving outcomes and the quality of life among those diagnosed with cancer. This coordinator will work with a collaborative team of study support staff under the direction of the PSTO research manager to support the Principal Investigator's research objectives.

Depending on study needs, employees may have a hybrid work schedule, working both remotely as well as on-site after the training period is complete. Employees may need to provide their own home office space, internet connection, telephone, and have the ability to work independently.

This position is eligible for university benefits. These benefits include:


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 here

Responsibilities
Responsibilities:This position will coordinate the technical and administrative details involved in a clinical or research study in the following ways:

  • Coordinating with Principal Investigators and other study staff to carry out research objectives from protocol planning and implementation to quality control and completion.
  • Creating and maintaining data, regulatory, and operational documentation for studies.
  • Working with other study coordinators, as well as biospecimen, data, regulatory, and financial support teams to develop and manage study resources and records.
  • Working with clinic staff to integrate study activities into clinic flow.
  • Oversee research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies.
  • Monitors budget expenses and billing for allied services.
  • Providing back-up team coverage when needed.



Essential Functions
  1. Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance.
  2. 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.
  3. Schedules and completes participant study visits and study procedures per protocol
  4. Collects, processes, and ships specimens per the study protocol
  5. Schedules and participates in site initiation visits, monitoring visits, and close-out visits
  6. Performs data entry, assurance, reporting activities and maintains information in study databases
  7. Reports and tracks deviations, adverse events (AE), and serious adverse events (SAE), as applicable
  8. Acts as a liaison between sponsors and the study team, and develops operating processes and procedures, as applicable
  9. Ensures regulatory requirements are met on research studies by maintaining and updating required regulatory documents
  10. Prepares IRB new study submissions, amendments, and renewals IRB submission and maintenance and other regulatory and compliance activities
  11. Represents the research program at meetings, national and international research consortia. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
  12. Supervises, mentors and trains new or junior research staff.
  13. Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
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 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 requiredNearly 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.

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.

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

Preferences
  • Experience with the IRB and ERICA
  • Experience with EPIC and electronic data capture systems, like REDCap
  • Experience in a healthcare setting or healthcare certification.
  • Ability to work as part of a team and also work independently.
  • Comfortable engaging with study participants in person, by phone, and virtually.





Special Instructions


Requisition Number: PRN40384B
Full Time or Part Time? Full Time
Work Schedule Summary:
Department: 02059 - HCI Popul Sci Trials Office
Location: Campus
Pay Rate Range: 39300 to 72700
Close Date: 2/19/2025
Open Until Filled:

To apply, visit https://utah.peopleadmin.com/postings/174277


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