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Michigan Medicine · 11 hours ago

Clinical Research Coord Inter

Ann Arbor, MI

Full-time

Onsite

Mid Level

3+ years exp

Michigan Medicine is part of the University of Michigan, focusing on advancing healthcare through surgical clinical trials. The Clinical Research Coordinator Intern will support various clinical studies, applying critical thinking and problem-solving skills while contributing to the development of processes and tools to enhance clinical research activities.

EducationHealth CareMedical

Responsibilities

Performs study procedures with accuracy

Triages complex study concerns appropriately

Schedules, prepares for, and attends study initiation meetings, monitor visits, and audits

Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently

Leads aortic clinical trials under supervision of Clinical Trial Lead and Clinical Research Manager

Contributes to the development of processes and tools to capture data in accordance with ALCOA-C principles

Creates CRFs, study documents, and tools

Resolves complicated queries

Monitors site compliance with subject safety reporting, escalates issues, and contributes to the development of tools and processes to enhance subject safety during the conduct of a clinical study

Demonstrates an understanding of Investigational products development process and applies key regulatory requirements to control these processes

Provides logistic and regulation guidance on Investigator Initiated Studies for adherence to University and Federal guidelines

Provides other administrative support for study activity including management of subject reimbursement and payments

Oversees aortic clinical research coordinator(s)

Supports study team members on a range of communication and teamwork best practices

Participates in trainings specifically for maintaining certification as a Clinical Research Professional

Qualification

Clinical Research CoordinationData ManagementRegulatory ComplianceGCP KnowledgeCommunication SkillsLeadership SkillsEthical ConsiderationsScientific ConceptsTraining ParticipationBachelor's DegreeClinical Trials ExperienceCertification (CCRC/CCRP)TeamworkProblem Solving

Required

Bachelor's degree in Health Science or an equivalent combination of related education and experience

Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP)

Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying

Company

Michigan Medicine

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Michigan Medicine is a health care system and academic medical center that provides medical education and more. It is a sub-organization of University of Maichigan.

Founded in 1869

Ann Arbor, Michigan, USA

10001+ employees