Job Details

PS Study Coordinator

Position Number: 6219203
Location: Salt Lake City, UT
Position Type: Laboratory and Research

PS Study Coordinator

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.

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

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 REDCap's 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
Reliable, 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

University of Utah Health Benefits Package University of Utah Health is proud to offer a generous benefits package! Our healthcare plans include medical and dental coverage, prescriptions, basic vision coverage, and behavior health benefits. Employees are eligible for a discount of up to $40 per month on their premiums for participating in our Well-U Wellness Program. Our retirement plan includes automatic enrollment into our University-funded 401(a) plan with a contribution rate of 14.2%! Additional benefits include half-off tuition for employees, their spouses, and their dependent children, University-provided Part I life insurance, and discounts through many retail vendors who have teamed up with the University. Visit our Benefits website for more information at www.hr.utah.edu/benefits.
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 (one year of education can be substituted for two years of related work experience) 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

Special Instructions

Requisition Number: PRN41851B
Full Time or Part Time? Full Time
Work Schedule Summary: Monday through Friday, 8:00am to 5:00pm. Some earlier mornings and later evenings may be required. Rotating on-call for holidays and as needed during weekend and night hours to provide study coverage.
Department: 00931 - Ob/Gyn Research Network
Location: Campus
Pay Rate Range: 31600 to 55621
Close Date: 7/8/2025
Open Until Filled:

To apply, visit https://utah.peopleadmin.com/postings/182260