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Michigan Medicine · 1 day ago

CRC - Project Manager underfill CRC Lead, CRC Senior

Ann Arbor, MI

Full-time

Hybrid

Senior Level

6+ years exp

Michigan Medicine is one of the largest health care complexes in the world, and they are seeking a Clinical Research Coordinator (CRC) Project Manager to oversee clinical research projects. The role involves ensuring projects are completed within specifications, managing resources, and leading a team of clinical research professionals.

EducationHealth CareMedical

Responsibilities

Set-up Unit Wide Systems Or Policies And Manage a Team Of Clinical Research Professionals (or Portfolios) In All 8 Competency Domains Is Expected:

Scientific Concepts and Research Design

Ethical Participant Safety Considerations

Investigational Products Development and Regulation

Clinical Study Operations (GCPs)

Study and Site Management

Data Management and Informatics

Leadership and Professionalism

Communication and Teamwork

Project Administration (Project Timelines, Project Meetings)

Regulatory (Central IRB, Trial Master File)

Data Oversight (e.g. site monitoring, auditing, etc.)

Demonstrates ability to create and manage the logistics for a new clinical research trial

Knowledge of the roles and responsibility of the various stakeholders in clinical research

Creates protocols for specimen collection, processing, shipping, etc., and implements procedures to maintain accuracy and efficiency

Clinical Coordinator Responsibilities

Proficient in study implementation

Data Coordinator Responsibilities (e.g. data abstraction, data entry, etc.)

Regulatory Coordinator Responsibilities

Applies critical thinking and creative problem solving skills in the development of new processes, procedures, tools, and training to enhance clinical research activities

Demonstrates the ability to evaluate a monitoring plan against protocol and relates the plan to study team members

Manage workloads and resources/procurement

Run staff meetings

Mentorship of clinical research professionals

Functional supervision

Knowledge of the principles and practices of leadership, management, and mentorship, and how to apply them within the working environment

All training requirements of the previous level

Specialty training or expertise is achieved at this level

Completes Michigan Medicine training for Managing Successfully and Leading Successfully

Attends and participates in all training assigned to this level

Other duties as assigned

Qualification

Clinical Research ManagementCertified Clinical Research CoordinatorProject ManagementHealth Science DegreeData ManagementLeadershipCommunicationTeamworkCritical ThinkingMentorship

Required

Masters Degree in Health Science or an equivalent combination of related education and experience is necessary

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 prior to applying.)

Minimum 6 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.)

Bachelors Degree in Health Science or an equivalent combination of related education and experience is necessary

Minimum 5 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.)

Preferred

Project Management certification

9+ years of direct related experience

Masters degree in Health Science or an equivalent combination of related education and related experience is desirable

9+ years of direct related experience

Benefits

Excellent medical, dental and vision coverage effective on your very first day

2:1 Match on retirement savings

Company

Michigan Medicine

Glassdoor4.0

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