University of Utah PS Clinical Research Coord in Salt Lake City, Utah
Open Date 09/15/2020
Requisition Number PRN24294B
Job Title PS Clinical Research Coord
Working Title PS 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
VP Area U of U Health - Academics
Department 00952 - Division of Epidemiology
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 39300 to 64349
Open Until Filled Yes
This position is within the Division of Epidemiology’s Program for Addiction Research, Clinical Care, Knowledge and Advocacy ( PARCKA ). This position will coordinate 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. PARCKA’s studies are conducted at various clinics in the Salt Lake City area. Job duties will require interaction with study participants, investigators, clinic and research staff, and study monitors. The incumbent will work closely with the project team to achieve study integrity and objectives through the successful implementation and completion of protocols and procedures.
1.Oversees 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, acting as a liaison between participants and study-related parties and study retention efforts to prevent study attrition
4.May travel to a variety of sites both within and outside the University campus to obtain data
5.May conduct research assessments, including structured assessments of sensitive topics with high-risk populations
6.Recognizes, tracks and reports adverse events and protocol deviations.
7.Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.
8.Attends and participates in investigator and staff meetings. May represent the research program at meetings, national and international research consortia.
9.Prepares, submits and maintains IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research correspondence.
10.Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
11.Supervises, mentors and trains new or junior research staff.
12.Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
13.Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
14.Assists the Principal Investigator in the development of study protocols
15.May ensure proper collection, processing and shipment of specimens.
16.Performs functions required of the Clinical Research Coordinator as necessary.
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
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.
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.
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: email@example.com 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: firstname.lastname@example.org .
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.
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.