Clinical Research Coordinator Job at University of Utah

University of Utah Salt Lake City, UT 84112

$22.88 - $43.46 an hour

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.
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.

Responsibilities
Essential Functions
  • 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.
  • Develop study budgets; monitor and billing; negotiate payment schedule and fees with sponsor.
  • Evaluate processes to identify obstacles to successful recruitment and retention of study participants. Recommend and implement innovative approaches to maximize enrollment and optimize subject retention.
  • Analyze study monitoring and operational reports to monitor production and data collection events; evaluate progress towards meeting required timelines and data collection tasks.
  • Implement procedures to prevent future events, including staff education and retraining
  • Prepare for and coordinate site visits made by sponsors or federal agencies during course and at the close of the study.
  • Represent the research program at meetings, national and international research consortia.
  • Prepare, submit and maintain IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence
  • Assist in the selection and hiring process for study staff; supervise, mentor and train new or junior research staff; provide direction and oversee preparation of study staff for monitoring visits; manage staff schedules ensuring shift/studies are covered; approve requests for time off/approve KRONOS.
  • Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
  • Develop training and staff certification materials, procedures and requirements. Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study. Oversee and train team members across the entire spectrum of research studies to include, but not limited to: protocol requirements, schedule of visits, recruitment plan, execution of research plan, collecting adverse event information, maintaining study subject documentation. Maintain records and other documentation of training.
  • Helps develop applicable data management queries and oversees data cleaning activities.
  • Determine subject population availability, develop recruitment, informed consents and screening materials; help develop survey and study data collection instruments
  • Evaluate new protocols for feasibility. Thoroughly review study protocols and map process and data flow to predict areas of vulnerability. Identify, recommend and implement solutions to address such vulnerabilities in specific trials and across the team’s study portfolio.
  • Coordinate approval of new study agreements and contracts; assists in the development of case report forms.
  • Develops QA/QC processes and conduct quality control activities (field/study visits, data queries.
  • Determine study visit and site/clinic work flows for studies/protocols
  • Works with data managers to help design, develop and test appropriate informatics tools to meet study data, participant and sample tracking needs
  • Helps to develop standard operating procedures
  • Compiles information for grant applications
  • Participates in abstract and manuscript preparation.

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, 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.

Comments:

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.

The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit. The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patient’s status and provide care as described in the department’s policies and procedures manual.

Disclaimer

This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It 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.

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Minimum Qualifications
Bachelor’s degree in a health science or related field or equivalency (one year of education can be substituted for two years of related work experience); 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

Type
Benefited Staff

Special Instructions Summary

Additional Information
The University of Utah values candidates who have experience working in settings with students from diverse backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.

Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities and protected veterans are encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities.

The University of Utah is an Affirmative Action/Equal Opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran’s status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.

To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Affirmative Action:

Director/ Title IX Coordinator

Office of Equal Opportunity and Affirmative Action ( OEO /AA)

383 University Street, Level 1 OEO Suite

Salt Lake City, UT 84112

801-581-8365

oeo@utah.edu

Online reports may be submitted at oeo.utah.edu

For more information: https://www.utah.edu/nondiscrimination/

To inquire about this posting, email: employment@utah.edu or call 801-581-2300.


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.

https://safety.utah.edu/safetyreport This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.

Posting Specific Questions

Required fields are indicated with an asterisk (*).

  • * Do you have a related Bachelor's degree or equivalency? (2 years related work experience may be substituted for 1 year of education)
    • Yes
    • No
  • * Please indicate the number of years of professional research experience that you have:
    • Less than 1 year
    • 1 year or more, but less than 2 years
    • 2 year or more, but less than 4 years
    • 4 years or more, but less than 6 years
    • 6 years or more

Applicant Documents

Required Documents
  • Resume
Optional Documents
  • Cover Letter
  • List of References

Open Date
05/17/2023

Requisition Number
PRN34999B

Job Title
PS Clinical Research Coord Sr.

Working Title
PS 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

VP Area
U of U Health - Academics

Department
00952 - Division of Epidemiology

Location
Campus

City
Salt Lake City, UT

Type of Recruitment
External Posting

Pay Rate Range
22.88 to 43.46

Close Date

Open Until Filled
Yes




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