Team Lead Research Coordinator- Clinical Trials

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Provides oversight for all aspects of clinical research occurring within the specified program and training and mentoring for clinical research personnel vides guidance and assistance in protocol development, serving as back-up coordinator to provide ongoing support for all trials in the specified program as needed. Communicates all relevant policy and procedure updates/revisions as directed by Manager, Research. Provides routine auditing/monitoring of ongoing trials for quality assurance purposes.

4 years of experience in clinical research or 3 years of experience in clinical research with advanced degree

• 2 years of experience in supervising staff
• Experience in creating and negotiating study budgets
• Experience in financial management
• Advanced degree

Bachelor’s degree in a scientific or health-related field

Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) Certified Research Associate (CRA), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or comparable within 1 year of employment ARUP Handling, Packaging and Shipping Infectious Substances or similar within 30 days of employment if role requires specimen acquisition. Collaborative Institutional Training Initiative (CITI) within 30 days of employment

Broad knowledge of federal regulations and regulatory requirements for conducting research with the ability to mentor Self-directed and motivated to work independently toward short- and long-term goals Good communication, organization, and interpersonal skills

• Develops, conducts, and facilitates research protocols at an expert level
• Collaborates with manager to assess data management needs
• Assists with development of source and case report form tools
• Provides back-up data entry services and ensures data integrity
• Assists with participant screening, enrollment, study activities, and communication
• Provides substantial support to investigators in writing study protocols
• Ensures protocol feasibility within ancillary departments
• Works collaboratively with manager to monitor metrics
• Manages a large or multiple smaller clinical trial projects
• Administers various research surveys in accordance with research study requirements
• Assists with identifying suitable grants for investigators
• Identifies and completes research grant applications
• Serves as back-up coordinator within identified service lines for all studies conducted in that service line
• Authorizes purchases for research supplies and equipment maintenance if applicable
• Leads others in sponsor correspondence, monitoring, and study meetings
• Serves as a resource for facilitating grants, contracts, and financial tasks for research and clinical trials
• Monitors expenditures and adherence to budget
• Assists research administration, financial Operations, and grants accounting in racking research billing to ensure research procedures are billed appropriately and resolves invoice-related issues with all parties involved
• Serves as resource for research administrative duties according to Children’s policies regarding Epic enrollment, Clinical Trial Management System data entry, patient care invoice accuracy
• Provides leadership for coordination of patient care to conduct research protocols
• Provides leadership and training related to all clinical research activities
• Provides research study education to participants as part of a study protocol
• Performs phlebotomy if trained to do so
• Completes research-only testing as required and applicable per-study and system requirements including electrocardiograms
• Completes documentation as needed within…