Apply on Employer Site

Michigan Medicine · 20 hours ago

Clinical Research Coord Inter TERM-LIMITED

Ann Arbor, MI

Full-time

Onsite

Mid, Senior Level

3+ years exp

Michigan Medicine is dedicated to improving health through education, patient care, and research. They are seeking a Clinical Research Coordinator to manage and coordinate clinical research studies, ensuring compliance with regulations and supporting the research team in various capacities.

EducationHealth CareMedical

Responsibilities

Manages and coordinates all aspects of assigned clinical research portfolio including but not limited to:

Regulatory submissions, creation/maintenance of regulatory binders

Subject screening, consenting, enrollment, management of study records

Data collection, entry, sharing, storage, management, query resolution

Create and complete case report forms, source documentation, study documents and tools

Database/survey development in various electronic platforms (REDCap, Qualtrics)

Effectively communicate with sponsors; coordinate, prepare, and attend visits for site initiation, monitoring, auditing, and/or closeout

Assess studies for execution and troubleshoot potential implementation issues

Provide cross-coverage on projects

Performs study procedures with accuracy

Demonstrates ability to triage complex study concerns appropriately

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

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

Resolves complicated queries

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

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

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

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

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

Qualification

Clinical Research CoordinationRegulatory SubmissionsData ManagementCertification (CCRC/CCRP)Communication SkillsCritical ThinkingOrganizational SkillsInterpersonal SkillsTeamworkProblem-Solving

Required

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

Excellent organizational skills and attention to detail

Superb interpersonal skills - comfortable speaking with healthcare providers, research sponsors, and patients

Ability to communicate effectively and professionally in both verbal and written form

Ability to work independently but also within a team

Ability to prioritize multiple tasks and meet deadlines are a must

Preferred

6+ years of direct related experience

Excellent communication skills

Ability to foresee needs of investigators/study teams and respond accordingly

Possess critical thinking skills

Ability to triage complex study concerns appropriately

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