PS Clinical Research Coord

PS Clinical Research Coord

Job Summary

Job Summary
The Division of Hematology-Oncology in the Department of Pediatrics, University of Utah School of Medicine, has an immediate opening for a Clinical Research Coordinator. The Clinical Research Coordinator assists the clinical trials process by registering hematology, oncology, and bone marrow transplant patients for clinical studies, assessing eligibility criteria, maintaining current protocol packets and assuring that all quality assurance measures are maintained within the protocol/study. Clinical trials are in most scenarios the standard of care for pediatric, adolescent, and young adults with malignant disease making this role vital not only to division operations, but more importantly to patients and families. The Clinical Research Coordinator assists the Primary Investigator in all IRB and regulatory submissions and clinical coordination specific to protocol. Duties include coordination of implementation, quality control and completion of research studies while assisting the Principal Investigator in determining and accomplishing study objectives. The Clinical Research Coordinator oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies.

The University of Utah offers a comprehensive benefits package including:

• Excellent health care coverage at affordable rates
• 14.2% retirement contributions that vest immediately
• Generous paid leave time
• 10 paid Holidays per year
• 50% tuition reduction for employee, spouse, and dependent children
• Flex spending accounts
• Free transit on most UTA services
• Employee discounts on a variety of products and services including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel
• Professional development opportunities

Additional benefits information is available at www.hr.utah.edu/benefits

Responsibilities
Essential Functions

1. In collaboration with the attending physician, recruit study subjects and ensure that all eligibility parameters are met. Ensure that informed consent is obtained prior to patient enrollment.
2. Register patients on clinical trials utilizing the appropriate registration process determined by the study group.
3. Prepare documents for each newly diagnosed patient to include protocol consent, eligibility and pre-treatment requirements.
4. Communicate process to obtain pathology and/or biology specimens and radiological imaging as required by protocol. Coordinate the submission of specimens with Primary Children's Hospital laboratory according to protocol guidelines and shipping regulations.
5. Daily review of next day's clinic records to ensure that current and correct treatment roadmap is available. Assist clinical care nurse coordinators and clinicians in obtaining current treatment roadmap for all inpatients.
6. Download information from clinical trial websites and maintain communication with consortiums as necessary. Maintain protocols by ensuring that new protocols, amendments and closures are updated on notification from consortia.
7. Responsible for all aspects of compliance for consortia within Primary Children's Hospital.
8. Assist physician investigator with communications to the various study chairs or group office as needed. Provide feedback to medical team on quality assurance issues, protocol violations and documentation issues.
9. Ensures appropriate research-related charges are routed correctly for payment processing.
10. Prepare all necessary documents for an Institutional Audit and/or site visit Peer Review
11. Provides cross-coverage as needed to ensure that the work requirements are met. Attends to other duties as assigned by supervisor.
12. Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.
    
    

Additional FunctionsThe Clinical Research Coordinator will also perform these functions in conjunction with existing staff and may provide cross coverage of these functions with other staff members:

1. Monitors enrollment and initiates strategies to promote participant compliance and ensuring protocol requirements are met. Coordinates and performs responsibilities related to research participants including screening subjects, scheduling visits, obtaining informed consent, answering inquiries, overseeing study visits, and acting as a liaison between participants and study-related parties.
2. Discuss study with subject and obtain informed consent; schedule assessment/visits; assure study visits and tests are done at appropriate time intervals.
3. Recognizes, tracks, and reports adverse events and protocol deviations
4. Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.
5. Represents the research program at national and international research consortia meetings.
6. Prepares, submits, and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence.
7. Supervises, mentors and trains new or junior research staff.
8. Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
9. Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
10. Assists in the development of departmental quality assurance practices and standard operating procedures.

Problem SolvingThe 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 COG, 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.

CommentsThe staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her 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.

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.

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Special Instructions


Requisition Number: PRN40333B
Full Time or Part Time? Full Time
Work Schedule Summary: Monday through Friday from 8am-5pm.
Department: 00848 - Pediatric Administration
Location: Campus
Pay Rate Range: $39,300-$68,349
Close Date: 2/14/2025
Open Until Filled:

To apply, visit https://utah.peopleadmin.com/postings/173987


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