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Clinical Research Coordinator

Job Summary
The Center on Mindfulness and Integrative Health Intervention Development (C-MIIND) is looking for a strong candidate who is interested in being a member of a research team dedicated to doing their part in solving today’s opioid epidemic.

This available position is for a Clinical Research Coordinator who will work on federally funded trials of mindfulness-based therapy for chronic pain, opioid misuse, and addiction (Mindfulness-Oriented Recovery Enhancement, see https://drericgarland.com/about-m-o-r-e/), and other adjunctive therapies (e.g., neurofeedback, virtual reality, ketamine assisted psychotherapy). The Clinical Research Coordinator coordinates the implementation, quality control and completion of clinical and biobehavioral research studies while assisting the Principal Investigator in determining and accomplishing study objectives. The Clinical Research Coordinator will oversee research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies. In addition, the Clinical Research Coordinator will recruit, enroll, and assess patients with multiple comorbidities, including chronic pain, mental health disorders, and substance use disorders.

The Center on Mindfulness and Integrative Health Intervention Development (C-MIIND) was established in May 2017 at the University of Utah with the following mission: to develop, test, optimize, and disseminate mindfulness and other integrative health interventions by translating discoveries from basic biobehavioral science into solutions for health and society. C-MIIND’s research efforts target complex, comorbid chronic health and mental health problems (chronic pain, opioid misuse, obesity, depression, addiction, etc.) that have not yet been solved by traditional medical approaches.

Ultimately, the Center strives to advance a vision of a new model of healthcare, in which behavioral health experts work in tandem with medical providers to address the physical, psychological, and social needs of people afflicted by an array of disorders and illnesses. The synergy generated by such integrative efforts will alleviate suffering and promote human flourishing to a degree unrealized in previous eras of health care reforms.
Responsibilities
Responsibilities
    1. compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.
    2. Develops study budgets; monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services.
    3. 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.
    4. Recognizes, tracks and reports adverse events and protocol deviations.
    5. Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.
    6. Represents the research program at meetings, national and international research consortia.
    7. Prepares, submits and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence.
    8. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
    9. Supervises, mentors and trains new or junior research staff.
    10. Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
    11. Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
    12. Assists the Principal Investigator in the development of study protocols.

 

Other Responsibilities:
  1. Recruits study participants and & obtains informed consent.
  2. Contacts participants to schedule study visits and follow-ups.
  3. Conducts research assessments, involving administration of structured clinical diagnostic interviews, self-report questionnaires, computer-based cognitive tasks, and psychophysiological measurement.
  4. Collects survey data.
  5. Reviews medical records.
  6. Consults with nurses & physicians to determine pretreatment & eligibility requirements of protocol from completion to registration of participants.
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.

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 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.

Preferences
  • A Master’s degree in social work, psychology, counseling, or nursing
  • >5 years of clinical trial research experience involving direct patient contact
  • Experience working with substance use disorders and/or chronic pain
  • Prior research experience collecting and processing physiological data (e.g., heart rate, EEG)

 

For more information or to apply, visit https://utah.peopleadmin.com/postings/137720

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Last Updated: 9/19/22