University of Utah Clinical Research Coord in Salt Lake City, Utah
Open Date 04/13/2021
Requisition Number PRN25814B
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
Work Schedule Summary
Monday – Friday, 8:00 AM – 5:00 PM
VP Area U of U Health - Academics
Department 00857 - Pediatric Hematology/Oncology
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range $39,300 - $64,349
Open Until Filled Yes
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. Provides instrumental support in 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. Assists the Primary Investigator in all IRB and regulatory submissions and clinical coordination specific to protocols. 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.
This position is considered Category I: Mandatory and required on campus or health care facilities to support on-site operations. Employees hired into this category will be required to be physically located at Primary Children’s Hospital and Outpatient Services Center at 100 Mario Capecchi Dr, Salt Lake City, UT, if they are healthy and without COVID -19 symptoms.
1.In collaboration with the attending physician, recruits study subjects and ensures that all eligibility parameters are met. Ensures that informed consent is obtained prior to patient enrollment.
2.Registers patients on clinical trials utilizing the appropriate registration process determined by the study group. Discusses study with subject and obtains informed consent; schedules assessment/visits; assures study visits and tests are done at appropriate time intervals.
3.Prepares packets for each newly diagnosed patient to include protocol consent, eligibility and
4.Communicates process to obtain pathology and/or biology specimens as required by protocol. Coordinates the submission of specimens with Primary Children’s Hospital laboratory according to protocol guidelines and shipping regulations.
5.Daily reviews of next day’s clinic records to ensure that current and correct roadmap is available. Assists Care Coordinators and LIPs in obtaining current roadmap for all inpatients.
6.Downloads information from clinical trial websites and maintains communication with Children’s Oncology Group ( COG ), Therapeutic Advances in Childhood Leukemia ( TACL ), Pacific Pediatric Neurooncology Consortium ( PNOC ), Sunshine Pediatric Sarcoma consortium, and Medulloblastoma Neuroblastoma Consortium. Maintains 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.Tracks all regulatory activity generated from consortia or other study governing bodies. Prepares and submits protocols, protocol amendments and necessary progress reports for all protocols to IRB for approval in accordance with regulatory and/or IRB requirements.
9.Assists physician investigator with communications to the various study chairs or group office as needed. Provides feedback to medical team on QA issues, protocol violations and documentation issues.
10.Prepares all necessary documents for an Institutional Audit and/or site visit Peer Review
11.Provides cross-coverage as needed to ensure that work requirements are met. Attends to other duties as assigned by supervisor.
12.Oversees protocol compliance; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.
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.
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.
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.
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.
Type Benefited Staff
Special Instructions Summary
The University of Utah is an Affirmative Action/Equal Opportunity employer and is committed to diversity in its workforce. In compliance with applicable federal and state laws, University of Utah policy of equal employment opportunity prohibits discrimination on the basis of race or ethnicity, religion, color, national origin, sex, age, sexual orientation, gender identity/expression, veteran’s status, status as a qualified person with a disability, or genetic information. Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities, and protected veterans are strongly encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law.
To inquire about this posting, email: firstname.lastname@example.org or call 801-581-2300. Reasonable accommodations in the application process will be provided to qualified individuals with disabilities. To request an accommodation or for further information about University AA/EO policies, please contact the Office of Equal Opportunity and Affirmative Action, 201 S. Presidents Cr., Rm 135, (801) 581-8365 (V/ TDD ), email: email@example.com .
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.