Job Information

University of Utah Study Coordinator in Salt Lake City, Utah

Open Date 04/27/2021

Requisition Number PRN25953B

Job Title PS Study Coordinator

Working Title Study Coordinator

Job Grade D

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 through Friday, 8:00am to 5:00pm. Some earlier mornings and later evenings may be required. On-call for holidays and as needed during weekend and night hours to provide study coverage.

VP Area U of U Health - Academics

Department 00931 - Ob/Gyn Research Network

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 31600 to 51699

Close Date

Open Until Filled Yes

Job Summary

Coordinates technical and administrative details involved in a clinical or research study. Assists the Principal Investigator in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures.

This position is Category I: Mandatory Required on Campus or at Health Care Facilities.

Responsibilities

General

•Manages multiple study protocols in various stages from start-up to close out.

•Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor.

•Attends, participates, and coordinates Investigator and staff meetings.

•Advises team regarding specific study assignments and timelines.

•Helps to revise or create a manual of operations if not provided.

•Tracks and reports screening, approach, and consented numbers to managers.

•Assists with negotiating contract budget and payment terms.

•Coordinates with office administration to obtain lab and technical supplies, issue participant payment, resolve research billing issues, or setup marketing materials or campaigns.

•Reviews and clears research related billing in a timely manner.

•Collaborates professionally internally and externally to ensure the success of all research under the department

•Maintain accurate and timely communication to team members

Research Studies

•Create study materials with clear and simplified guidelines based on the MOP

•Manages screening and enrollment logs

•Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety.

•Trains research assistants and other research staff as needed on protocols and office operations.

•Be available to any staff working on your studies

•May perform functions required of a Research Assistant as necessary.

•Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor.

Laboratory & Sample Processing

•Ensure compliance to laboratory rules and regulations to ensure safety and integrity of all research samples and staff

•Notify Lab Manager of any issues, concerns, or supplies needed

•Ensures proper collection, storage, and inventory of study samples.

•Maintain all research supplies, ensuring organization and ease of access for staff

•Maintain shipping certification

Data Collection

•Assists in building or reviewing all REDCaps as needed by the OGRN department

•Verify all data entered into research studies databases are accurate and verified

•Completes, audits, corrects CRFs, relays CRFs to sponsor.

•Complete data cleaning practices periodically to ensure quality of data

•Assist PI’s with data pulls from our databases as needed, or facilitating statistical analysis support as needed with the OGRN biostatistician

Compliance

•Works with the Regulatory Manager to ensure reporting and documentation comply with FDA , IRB , and sponsor regulations

•Maintains all regulatory logs ( DOA , Training Logs, and any needed Note to File)

•Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor.

•Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor.

•Provides, Tracks and participates in audits of participant compensation

Departmental

•Collaboration: Works effectively with others to meet goals and satisfy Department objectives, by developing and maintaining strong relationships with internal and external partners, fosters an inclusive culture in which people from diverse backgrounds are respected and valued

•Communication: Listens to attentively and with empathy to concerns expressed by others, tailors message to the audience, keeps people up to date with information, and encourages others to express their views.

•Demonstrates Accountability: Accepts responsibly for one’s own performance and actions, follows through on commitments, treats others fairly and consistently and protects confidential information.

•Demonstrates Inclusive Behavior: Listens with an open mind to understand different points of view. Encourages others to share their thoughts and is proactive to offer support.

•Engages and Inspires Others: Conveys trust in people’s competence to do their jobs, creates a feeling of energy, excitement, and personal investment, inspires others to excel, rewards and recognizes great performance.

•Facilitates cooperative and collaborative community and institutional relationships.

Team Culture

•Supports an inclusive, transparent and supportive work environment

oReliable, displays a positive attitude, does not engage in gossip, supports the team and is flexible

•Communicates problems, issues and frustrations to supervisor and/or OB/ WCSL Leadership

Work Environment and Level of Frequency that may be required

Nearly Continuously: Office environment.

Physical Requirements and Level of Frequency that may be required

Nearly Continuously: Sitting, hearing, listening, talking.

Often: Repetitive hand motion (such as typing), walking.

Seldom: Bending, reaching overhead.

Minimum Qualifications

Bachelor’s degree in a related field, or equivalency required. IRB CITI Course in the Protection of Human Research subjects certificate obtained within six months of hire and demonstrated human relations and effective communication skills are also required.

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.

Some departments may require IATA DGR training within six months.

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)

135 Park Building

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 (%20employment@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.