Job Details

University of Utah
  • Position Number: 6288455
  • Location: Salt Lake City, UT
  • Position Type: Medicine - Medical Researcher


PS Clinical Research Coord Sr.

Job Summary

Job Summary
The Division of Pediatric Neurology at the University of Utah School of Medicine has an opening for a Senior Clinical Research Coordinator. Coordinates complex clinical trial activities and plays a critical role in the conduct of multiple research studies.
 
The Department of Pediatrics is the second largest department in the University of Utah School of Medicine and one of the largest pediatric departments in the country. We are committed to improving the lives of children through excellence in advocacy, education, research, and clinical care. For more information about the Department of Pediatrics, please visit: http://medicine.utah.edu/pediatrics/. Mutual respect and appreciation are highly valued in the department.
 
The University of Utah offers a comprehensive benefits package including:
Additional benefits information is available at https://benefits.utah.edu/ 
 



Responsibilities
Essential Functions
  • 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 clinical research trials and across the team's study portfolio.
  • Work with PI to assess administration and logistics of the study protocol, review inclusion and exclusion criteria, scientific, ethical and regulatory issues; patient population, logistics, and protocol compliance.
  • Work with the study team and the PI within the University and Primary Children's Hospital to ensure efficient study start-up.
  • Organize pre-site selection visits and site initiation visits with study monitors and design, develop, and implement recruitment and retention plans for each study.
  • Work in harmony with Business Development Director and start-up teams on efficiently starting up new clinical research studies.
  • Assist in the development of standard operating procedures.
  • Mentor and train new or junior research staff.
  • 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.
  • 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 when assistance is needed.
  • Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
  • Assist in the development of 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.
  • Determine subject population availability, develop recruitment, informed consents, and screening materials; help develop survey and study data collection instruments.
  • Assist in the development of case report forms.
  • Determine study visit and site/clinic workflows for studies/protocols.



CommentsWork 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 requiredNearly 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.


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
Preferences
  • Experience managing multiple investigator-led projects
  • Prior experience in both sponsor-initiated and investigator-initiated study startups
  • Current CCRC, CCRP, or equivalent certification is strongly preferred.
  • Effective oral and written communication skills. Ability to communicate efficiently on different levels and work on several projects at once with high flexibility.
  • Detail oriented with excellent time management and organizational skills.
  • Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; extensive understanding of research procedures.
  • Ability to function independently.
  • IRB CITI Course is required within one month of hire.
  • Redcap Experience
  • Experience working with IRB



Applicants will be screened according to preferences.

Special Instructions


Requisition Number: PRN42144B
Full Time or Part Time? Full Time
Work Schedule Summary: Monday through Friday from 8am-5pm.
Department: 00848 - Pediatric Administration
Location: Campus
Pay Rate Range: $47,600 - $84,249
Close Date: 9/9/2025
Open Until Filled:

To apply, visit https://utah.peopleadmin.com/postings/183739







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