Details

Open Date 05/23/2023

Requisition Number PRN35094B

Job Title PS Clinical Research Coord

Working Title Clinical Research Coord

Job Grade E

FLSA Code Administrative

Patient Sensitive Job Code? Yes

Standard Hours per Week 40

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

Monday – Friday, 8:00 AM to 5:00 PM

VP Area U of U Health - Academics

Department 00857 - Pediatric Hematology/Oncology

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range $39,300 to $64,349

Close Date

Open Until Filled Yes

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. This is an exciting opportunity to join our Bone Marrow Transplant and Immunology research team. This team will work on various consortium (Primary Immune Deficiency Treatment Consortium, Center for International Blood and Marrow Transplant Research, Children’s Oncology Group) sponsored clinical trials as well as a myriad of industry/governmental sponsored trials. Come be part of the team to help in the fight against childhood cancer and other nonmalignant disorders.

The Clinical Research Coordinator assists the clinical trials process by registering patients for clinical studies, assessing eligibility criteria, maintaining current protocol packets and assuring that all quality assurance measures are maintained within the protocol/study. The Clinical Research Coordinator assists the Primary Investigator in all IRB and regulatory submissions and clinical coordination specific to protocol. 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.

The University of Utah offers a comprehensive benefits package including:

• Excellenthealth care coverage (https://www.hr.utah.edu/forms/lib/SummaryComparisonEmployeeHCP.pdf) at affordable rates
• 14.2% retirement contributions (https://www.hr.utah.edu/benefits/retire\_401aPlan.php) that vest immediately
• Generouspaid leave time (https://www.hr.utah.edu/benefits/paidLeave.php)
• 11 paid Holidays per year
• 50% tuition reduction (https://www.hr.utah.edu/benefits/tuition.php) for employee, spouse, and dependent children
• Flex spending accounts (https://www.hr.utah.edu/benefits/fsa.php)
• 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

Disclaimer

This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It 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.

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. Discuss study with subject and obtain informed consent; schedule assessment/visits; assure study visits and tests are done at appropriate time intervals.
3. Prepare packets for each newly diagnosed patient to include protocol consent, eligibility and pre-treatment requirements.
4. Communicate process to obtain pathology and/or biology specimens as required by protocol. Coordinate the submission of specimens with PCH laboratory according to protocol guidelines and shipping regulations.
5. Daily review of next day’s clinic records to ensure that current and correct roadmap is available. Assist Care Coordinators and LIPs in obtaining current roadmaps for all inpatients.
6. Download information from clinical trial websites and maintain communication with the various consortiums. Maintain protocols by ensuring that new protocols, amendments, and closures are updated on notification from consortia.
7. Responsible for all aspects of regulatory compliance for consortia within Primary Children’s Hospital.
8. Track all regulatory activity generated from consortia or other study governing bodies. Prepare and submit protocols, protocol amendments and necessary progress reports for all protocols to IRB for approval in accordance with regulatory and/or IRB requirements.
9. Assist physician investigator with communications to the various study chairs or group office as needed. Provide feedback to medical team on QA issues, protocol violations and documentation issues.
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 Functions

The 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. Develops study budgets; monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services.
2. 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.
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 meetings, and national and international research consortia.
6. Prepares, submits and maintains IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research correspondence.
7. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
8. Supervises, mentors and trains new or junior research staff.
9. Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
10. Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
11. Assists the Principal Investigator in the development of study protocols.

Comments

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.

The 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.

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 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 subject’s 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.

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

Type Benefited Staff

Special Instructions Summary

Additional Information

The University of Utah values candidates who have experience working in settings with students from diverse backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.

Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities and protected veterans are encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities.

The University of Utah is an Affirmative Action/Equal Opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran’s status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.

To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Affirmative Action:

Director/ Title IX Coordinator

Office of Equal Opportunity and Affirmative Action ( OEO /AA)

383 University Street, Level 1 OEO Suite

Salt Lake City, UT 84112

801-581-8365

oeo@utah.edu

Online reports may be submitted at oeo.utah.edu

For more information: https://www.utah.edu/nondiscrimination/

To inquire about this posting, email: employment@utah.edu (%20employment@utah.edu) or call 801-581-2300.

The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.

This position may require the successful completion of a criminal background check and/or drug screen.

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