University of Utah PS Study Coordinator in Salt Lake City, Utah
Open Date 12/03/2018
Requisition Number PRN19084B
Job Title Study Coordinator
Working Title PS 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
Work Schedule Summary
Monday – Friday, 3:00 p.m. – 11:30 p.m. (swing shift), shared on-call responsibilities.
VP Area U of U Health - Academics
Department 00852 - Pediatric Emergency Medicine
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range $31,600 - $51,699
Open Until Filled Yes
The Department of Pediatrics at the University of Utah School of Medicine is seeking a Study Coordinator to provide technical and administrative support for research activities within the Division of Pediatric Emergency Medicine. The incumbent is responsible to organize, implement, oversee, coordinate, and support technical and administrative details of division clinical research activities, while assisting the Principal Investigator in identifying and accomplishing study objectives. Incumbent maintains compliance to a host of department, university, and governing agency requirements and regulations.
•Coordinates multiple research projects and activities. Oversees day-to-day clinical research activities to guarantee the effective follow-through of all study protocols. (40%)
•Collaborates with the project PIs to identify research project goals, assess protocol for clarity and subject safety, review inclusion/exclusion criteria, and then designs a system to accomplish these goals within study time frame and budget constraints. (10%)
•Supports preparatory study activities by designing site workflow, helping with writing of the Manual of Operations, designing training programs and work flow. (10%)
•Meets often with PIs, managers, and other research coordinators to update overall study progress and make modifications as needed.
•Designs documents, devices, tools, and educational programs to facilitate accurate data collection and to ensure proper patient capture. (15%)
•Explains and obtains informed consent, medical history and demographics; documents and maintains historical data, status reports, progress notes, and subject logs to help ensure subject safety. (5%)
•Ensures that the quantity and quality of data meets specific project objectives while preserving the integrity of scientific research. Maintains validity and verifies accuracy of data. (10%)
•Recognizes, tracks, and reports adverse events and protocol deviations.
•Coordinates with the lab for shipping and tracking of biological samples taken from study patients.
•Participates in shared on-call responsibilities for enrolling study patients. (5%)
•Completes, audits, and maintains study records, materials, and databases (including Case Report Forms, Serious Adverse Reports,IRBsubmissions, Essential Documents, and patient data) to ensure compliance with study protocols,FDA,IRB, and other university regulations and guidelines.
•Prepares, submits and maintainsIRB,FDA,NIHand all other regulatory processes to ensure compliance with good clinical research standards and practices.
•Tracks adverse events. Reports serious adverse events and protocol violations toIRBand sponsor.
•Assists in training, oversight and mentoring of research assistants. Assists in developing and documenting research education programs for clinical staff. (5%)
•Pursues additional research education opportunities by attending Research Administration Training Series and works towards certification.
•Provides continual didactic education and on-the-job training and feedback to Academic Associate students, providing continual feedback and study updates in order to enhance their learning experience and ensure the quality of their work.
•Performs other necessary research support functions as assigned by PI, manager, clinical research coordinator, or division chief.
•Attends and participates in division Career Development meetings.
•Demonstrates initiative, enthusiasm, positive attitude, teamwork, and commitment to the research mission of DoPEM and the Department of Pediatrics by providing assistance and support as needed and where directed.
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.
Bachelor’s degree in a related field, or equivalency required.IRBCITICourse 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.
Some departments may requireIATADGRtraining within six months.
One year experience with clinical research, including research study protocols, procedures, data collection, good clinical practice, and compliance withIRB,FDA,HIPAAregulations, and multi-site collaboration. Administrative experience with organizing and coordinating multiple research projects running simultaneously, along with a basic understanding of emergency medicine clinical practices and medical terminology. Working knowledge of computers, research software programs, and large databases. Ability to effectively communicate and work with research subjects and medical, administrative, and research personnel at all levels and within different organizations and cultures. Prefer prior completion of Academic Associate 5900 course.
Type Benefited Staff
Special Instructions Summary
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: firstname.lastname@example.org 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: email@example.com .
The University is a participating employer with Utah Retirement Systems (“URS”). To be eligible for retirement contributions, you must be hired into a benefit-eligible position. Certain new hires are automatically assigned to the URS retirement plan and other employees with prior URS service, may elect to enroll in the URS within 30 days of hire. Regardless of whether they are hired into a benefit-eligible position or not, individuals who previously retired and are receiving monthly retirement benefits from URS must notify the Benefits Department upon hire. Please contact Utah Retirement Systems at (801)366-7770 or (800)695-4877 or the University’s Benefits Department at (801)581-7447 for information.
This position may require the successful completion of a criminal background check and/or drug screen.