Job Information

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

Open Date 05/18/2021

Requisition Number PRN26171B

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. Some flexibility for holidays and weekends required.

VP Area U of U Health - Academics

Department 00849 - Pediatric Cardiology

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 to provide support to Principal Investigators in the Division of Pediatric Cardiology. Responsible for coordinating the implementation, quality control and completion of research studies while accomplishing study objectives and maintaining compliance with guidelines set by government agencies. Responsibilities include organizing pedigrees, interfacing with patients and families, obtaining informed consents, supervising data collection, and entering study data in electronic databases.

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 Outpatient Services Building and Primary Children’s Hospital if they are healthy and without COVID -19 symptoms.

Responsibilities

Essential Functions

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 for allied services; negotiates payment schedule with sponsor and fees for internal services.

3.Disseminates information about the protocol to junior research staff and auxiliary personnel.

4.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.

5.Coordinates with data managers to monitor participant progression throughout study and conducts evaluation at end of study.

6.Creates a system to track data entry and audit for completeness, accuracy, and timeliness of data collection.

7.Recognizes, tracks and reports adverse events and protocol deviations.

8.Prepares for and coordinates site visits made by sponsors or federal agencies during the course of and at the close of the study.

9.Prepares, submits and maintains IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research correspondence.

10.Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.

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

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

13.Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.

14.Assists the Principal Investigator in the development of study materials and protocols.

15.Attends all appropriate meetings as determined by the Primary Investigator and Pediatric Cardiology Research Manager.

16.Organizes the activities within the assigned grant proposals under the direction of the Primary Investigator.

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 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

•Registered nurse is preferred

•Prior experience in pediatrics and/or cardiovascular clinical research areas

•Credentialing as a Certified Clinical Research Coordinator ( CCRC ), Certified Clinical Research Professional ( CCRP ), or other related certification

•Experience with human subjects research, demonstrated human relations skills, and working knowledge of Good Clinical Practices, FDA , HIPPA ICH , and IRB regulations and regulatory compliance

•Self-starter with exceptional organizational skills, ability to function independently, and attention to detail

•Excellent interpersonal and communications skills, both oral and written

•Proficiency in Microsoft Office and the ability to learn new software programs

• IRB CITI Course for Human Subjects and CITI GCP or IATA DGR training are required within 3 weeks of hire

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.