Job Details

Clinical Research Coordinator Sr.

Position Number: 6637708
Location: Salt Lake City, UT
Position Type: Laboratory and Research

Clinical Research Coordinator Sr.

Job Summary

The Division of Pediatric Behavioral Health at the Spencer Fox School of Medicine has an immediate opening for a Sr. Clinical Research Coordinator (Sr. CRC). The Sr. CRC will play a central role in managing a federally funded (NIH K23) multi-site research study focused on decision aids and sexual health education in collaboration within the Differences of Sex Development Translation Research Network (DSD-TRN). This position coordinates and oversees participant recruitment, study implementation, quality control and data management and stakeholder engagement, while supporting the Principal Investigator (PI) in day-to-day operations and assists with accomplishing study objectives.

Responsibilities
Essential Functions

Lead and manage all aspects of subject recruitment efforts. Determine subject population availability using EMR, develop recruitment, informed consents and screening materials; develop survey and study data collection instruments; create and distribute recruitment materials (letters, emails, phone scripts) for patients, parents, and healthcare providers.
Conduct structured interviews with participants, parents and healthcare providers, adhering to standardized guidelines. Schedule patient sessions and communicate session reminders to study participants.
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.
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
Prepares, submits and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence.
Maintain and update REDCap databases, including creating consent forms and surveys to support the K23 project, ensuring data integrity and usability.
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.
Prepare for and coordinate site visits made by sponsors or federal agencies during course and at the close of the study.
Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
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.
Help develop and design applicable data management queries and tools to meet tracking needs, and oversees data cleaning activities.
Coordinate approval of new study agreements and contracts; assist 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 workflows for studies/protocols.
Help to develop standard operating procedures.
Collaborate with PI to identify funding opportunities and develop grant proposals for internal and federal sources, such as NIH and PCORI. Requires reviewing available funding notices, coordinating meetings, drafting and editing sections of the grant application, and coordinating the Pre-Aware Office to ensure submission readiness.
Participates in abstract and manuscript preparation, including supporting volunteers to complete literature searches and outline development.
Oversee and manage undergraduate and graduate student volunteers, which may include scheduling, delegating tasks accordingly, and training.
Contributes to developing sexual health educational materials and educates the community and other research professionals regarding studies and related research issues.
Represent the research program at meetings, national and international research consortia.

Problem SolvingThe 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 subject's 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 for organizing coverage when not present to ensure protocol requirements are followed.
DisclaimerThis 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.CommentsWork Environment and Level of Frequency that may be requiredNearly continuously: Office environment, Virtual.Physical Requirements and Level of Frequency that may be requiredNearly continuously: Sitting, hearing, listening, talking.Often: Repetitive hand motion (such as typing), walking.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 within the department of Pediatrics. The individual must demonstrate knowledge of the principles of life span growth and development, a thorough understanding of pediatric DSD, and the ability to utilize qualitative and quantitative data as described in the PI's research procedures manual.

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.

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
Preferences

Master's degree in a related area of assignment
10 years of experience managing NIH grants
Detailed knowledge of pediatric Differences of Sex Development (DSD) is strongly preferred in order to implement ongoing research projects and support the development of additional research endeavors.
Experience with DSD is particularly important as this is a unique population with specific needs. Additionally, as this position will include interactions with research participants, applicants must possess strong interpersonal skills.
5 years' experience in research design, protocol development, and implementing quantitative and qualitative research methods, including leading interviews and data analysis.
Grant writing experience that has led to federally funded research projects.
Advanced knowledge and experience with REDCap, as branching lodging, etc.

Applicants will be screened according to preferences.

Special Instructions

Requisition Number: PRN16440N
Full Time or Part Time? Part Time
Work Schedule Summary: This is a 0.49 FTE role that is not eligible for benefits. Variable schedule with availability Monday through Friday, from 8:00 a.m. to 5:00 p.m. Mountain Time. Opportunities for telework may be considered if supported by operational needs.
Department: 00848 - Pediatric Administration
Location: Campus
Pay Rate Range: $22.88 to $40.50
Close Date: 10/31/2025
Open Until Filled:

To apply, visit https://utah.peopleadmin.com/postings/190094