University of Utah PS Clinical Research Coord in Salt Lake City, Utah

Details

Open Date 03/01/2019

Requisition Number PRN19750B

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

Shift Day

Work Schedule Summary

Monday – Friday, 9:00 a.m. – 5:30 p.m. Occasional weekends and after hours required.

VP Area U of U Health - Academics

Department 01643 - CLINICAL TRIALS OFFICE

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

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

Close Date

Open Until Filled Yes

Job Summary

The Department of Pediatrics at the University of Utah School of Medicine has an immediate opening for a Clinical Research Coordinator.

This position 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. Examples of responsibilities include, interfacing with patients and families, obtaining informed consents, supervising data collection, and entering study data in electronic databases. And mentoring junior staff.

The University of Utah offers a comprehensive benefits package, a wellness program, and competitive salary commensurate with experience. Mutual respect and appreciation are highly valued within the University of Utah.

Responsibilities

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 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 maintainsIRB,FDA,NCI,NIH,NSFand/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 junior or student 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.

13.Assures proper laboratory samples are collected and results are reported to the proper entities.

14.Completes ongoing training on techniques of clinical research coordination and practices,FDAGood Clinical Practices (GCP), and clinical research standard operating procedures to ensure compliance with policy and procedure, research sponsors and Federal rules and regulations.

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, followingFDA, Good Clinical Practice,IRB,NIH,NCI,NSFand/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 UniversityRATSClinical 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,HIPAAandIRBregulations; an understanding of research procedures; and the ability to function independently is preferred.

Departments may requireIRBCITICourse orIATADGRtraining 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 toCDCstandards 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

•Industry andNIHstudy experience.

•Hematology experience preferred.

Type Benefited Staff

Special Instructions Summary

Additional Information

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: employment@utah.edu 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: oeo@umail.utah.edu .

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 priorURSservice, may elect to enroll inURSif 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 fromURSare 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.