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University of Utah Health Research · 15 hours ago

Clinical Research Coordinator

Salt Lake City, UT

Full-time

Hybrid

Entry, Mid, Senior Level

$0/yr - $59K/yr

2+ years exp

The University of Utah College of Health and Department of Physical Therapy & Athletic Training is seeking an individual to support clinical research studies evaluating various rehabilitation interventions for persons with chronic pain that use telehealth. The successful applicant will interact with patients by phone or video call throughout the state of Utah, and also with other research staff members and investigators.

Higher Education

Responsibilities

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

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 as needed

Prepare, submit and maintain IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research correspondence

Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues

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. Assist with training 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

Help develop applicable data management queries and oversees data cleaning activities

Determine subject population availability, develop recruitment, informed consents and screening materials; help develop survey and study data collection instruments

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

Coordinate approval of new study agreements and contracts; assists 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 work flows for studies/protocols

Work with data managers to help design, develop and test appropriate informatics tools to meet study data, participant and sample tracking needs

Helps to develop standard operating procedures

Participates in abstract and manuscript preparation

Qualification

Clinical Research CoordinationClinical PracticesRegulatory ComplianceData ManagementMicrosoft Office ProficiencyBilingual (English/Spanish)Training DevelopmentResearch Procedures KnowledgeQuality Control ActivitiesSoftware Learning AbilityHuman Relations SkillsOrganizational SkillsEffective CommunicationAttention to DetailTeam CollaborationProblem Solving

Required

Able to communicate in both English and Spanish

1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor's degree = 4 years of directly related work experience)

Clinical Research Coordinator (Non-R.N.), I: Requires a bachelor's (or equivalency) + 2 years of directly related work experience or a master's (or equivalency) degree

Clinical Research Coordinator (Non-R.N.), II: Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience

Clinical Research Coordinator (Non-R.N.), III: Requires a bachelor's (or equivalency) + 6 years or a master's (or equivalency) + 4 years of directly related work experience

Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills

Preferred

Bachelor's degree in a health science or related field or equivalency; plus, 4 years professional research experience

Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently

Credentialing as a Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or other related certification

Proficiency in Microsoft Office and ability to learn new software programs

Experience with RedCap and Microsoft products