Clinical Research Coord Inter

Michigan Medicine; Ann Arbor (MI); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Excellent medical, dental and vision

2:1 retirement match

Job summary

Michigan Medicine seeks a responsible Clinical Research Coordinator to independently coordinate simple to moderately complex studies. This role supports a portfolio across varied projects, mentoring others and contributing to process improvements.

It requires advanced knowledge of study operations and collaboration with diverse teams. The position emphasizes quality assurance, professional development, and participation in committees, with a two-year term and potential extension based on funds.

Qualifications

• Bachelor's degree in Health Science or equivalent required.
• Certification as a Clinical Research Coordinator or similar is preferred/required within six months of hire.
• Minimum 3 years of directly related clinical research experience.
• Strong organizational and communication skills.

Responsibilities

• Manages and coordinates all aspects of assigned clinical research portfolio including regulatory submissions and maintenance of regulatory binders.
• Subject screening, consenting, enrollment, and management of study records.
• Data collection, entry, sharing, storage, management, and query resolution.
• Create and complete case report forms, source documentation, and study documents/tools.
• Database/survey development in REDCap/Qualtrics and related platforms.
• Coordinate sponsor visits, site initiation, monitoring, and closeout; ensure regulatory compliance.

Skills

Attention to detail

Communication

Teamwork

GCP knowledge

Education

Bachelor's degree in Health Science or related

Tools

REDCap

Qualtrics

Job description

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Job Summary

We are seeking a responsible, motivated, individual who will independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this clinical research coordinator (CRC) position may help support a portfolio of projects with varying levels of complexity. Coordinator experience and mastery of all job duties from the CRC-Associate position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support. This position has a term limitation of 2 years, with an option to extend if funds are available.

Characteristic Duties And Responsibilities

Expert level knowledge, skills, and abilities within 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

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

Required Qualifications

• 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.

Desired Qualifications

• 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

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world?s most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

Work Schedule

This is a full-time regular position. Monday-Friday: 8am-4:30pm; On-site work required. Travel to satellite clinics may be required.

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO Statement

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.