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

Open Date 09/10/2020

Requisition Number PRN24277B

Job Title PS Clinical Research Coord Sr.

Working Title Clinical Research Coord Sr.

Job Grade F

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 – 5:00 pm. Occasional evening, weekend, and holiday hours required based on operational needs.

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 $47,600 - $79,699

Close Date

Open Until Filled Yes

Job Summary

The Division of Pediatric Cardiology at the University Of Utah School Of Medicine has an immediate opening for a Senior Clinical Research Coordinator to provide support to Principal Investigators within the Heart Center. This successful candidate will assist in facilitating the conduct of clinical research by performing research and clinical duties, providing protocol-driven patient care for complex clinical trial activities in compliance with guidelines set by governing agencies. Actual skills and responsibilities will vary according to the specific research project.

Additionally, the successful candidate for this position will be responsible for coordinating the implementation, quality control and completion of research studies while accomplishing study objectives and for maintaining compliance with guidelines set by government agencies. The person in this position will have 2 primary areas of responsibility: 1) work with Heart Center Principal Investigators 2) conduct studies within the Bench to Bassinet Translational Research Program. Specific responsibilities include participation in protocol development, creating and piloting data collection forms, identification of potential subjects, interfacing with patients and families, obtaining informed consents, scheduling study visits and tests, supervising data collection, entering study data in databases, maintaining all regulatory documents, securing and ensuring proper handling of study samples, and distributing and maintaining documentation of patient incentives. Coordinators will use medical knowledge and clinical experience to perform multiple functions for this position, including but not limited to analyzing or evaluating clinical data, developing and implementing clinical workflows for studies/protocols, performing medical reviews, and training research coordinators throughout the network. The Research Senior Coordinator will have the opportunity to participate in the dissemination of results through abstract and manuscript production as appropriate.

The University of Utah offers a comprehensive benefits package with excellent health care choices, retirement plans and paid leave time. Current benefit information is available at www.hr.utah.edu/benefits.

Responsibilities

1.Oversee, assess and ensure participant safety and strict protocol implementation/adherence; oversee compliance with GCP guidelines, federal regulations, institutional policies and procedures, and internal SOPs.

2.Assists in development of study budgets; monitors budget expenses for allied services; maintains all billing, incentive, and reimbursement records.

3.Disseminates information about the protocol 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.Analyze study monitoring and operational reports to monitor production and data collection events; evaluate progress towards meeting required timelines and data collection tasks.

6.Works with the Data Coordinating Center to monitor participant progression throughout study and conducts evaluation at pre-specified intervals and at end of study.

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

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

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

10.Implement procedures to prevent future events, including staff education and retraining

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

12.Develops and maintains patient databases, investigational logs and records of drugs administered and/or procedures followed.

13.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.

14.Assures proper laboratory samples are collected and shipped per study protocol and results are reported to the proper entities.

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

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

17.Represent the research program at meetings, national and international research consortia as determined by the Principal Investigator and Pediatric Heart Center Administrative Research Director.

18.Organizes the activities within the assigned grant proposals under the direction of the Principal Investigator.

19.Plays a central role in assuring participant safety, ongoing maintenance of informed consent, integrity of protocol implementation accuracy of data collection, data recording and follow up.

20.Provides care received to research participants driven by study requirements and the collection of research data as well as clinical indications. Study procedures may include administration of investigational drugs and monitoring of side effects, performance of an experimental or investigational surgical or radiological procedure, detailed clinical assessment, for example.

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

Bachelor’s degree in a health science or related field or equivalency; plus, 4 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.

Care is appropriate to the population served

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Preferences

•Current licensure as a Registered Nurse in the State of Utah.

•Four years of professional clinical research experience (i.e. Clinical Research Coordinator, Regulatory Coordinator, or other related CRC level research experience, performing advanced and complex clinical research functions).

•Prior experience in the 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.

•Must be a 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 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.

Applicants will be screened according to preferences.

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 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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