Clinical Research Coordinator Intermediate

University Of Michigan; Ann Arbor (MI); Hybrid; USD 60,000 - 90,000; Full time

Benefits offered by this job

Excellent medical, dental and vision

2:1 retirement matching

Job summary

Michigan Medicine is seeking a Clinical Research Coordinator (Intermediate) to support the Scleroderma Program in the Division of Rheumatology. The role requires advanced coordination, regulatory oversight and data management across multiple studies, with opportunities to mentor staff and improve processes.

The successful candidate will coordinate screening, consent, visits, HSIP submissions, and data collection while ensuring GCP/IRB compliance.

Qualifications

• Bachelor's degree in Health Science or equivalent is required.
• Certification through ACRP (CCRC) or SoCRA (CCRP) or equivalent required within six months of hire.

Responsibilities

• Coordinate pharmaceutical-funded and investigator-initiated studies.
• Develop tools and processes across 8 competency domains.
• Coordinate subject screening, consent, visits, and follow-ups.
• Ensure data quality and manage data entry and analysis.

Skills

Study coordination

Regulatory compliance

Data management

Communication

Education

Bachelor's degree in Health Science

Tools

ClinicalTrials.gov

Job description

Clinical Research Coordinator Intermediate

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

The clinical research coordinator (CRC) position will provide study coordination for multiple clinical research studies of varying complexity for the Scleroderma Program in the Division of Rheumatology. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and mentor study team members in the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies including developing new processes, procedures, tools, and training to enhance clinical research activities across the competency domains. This position continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development.

Responsibilities*

The position is looking to hire a coordinator with expertise in conducting pharmaceutical-funded & investigator -initiated clinical studies and trials.

Contribution to the development of process and tools 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

Participant Screening and Recruitment

• Explaining study thoroughly, reviewing informed consent, answering any questions, following GCP/IRB guidelines and obtaining consent
• Demonstrates ability to triage complex study concerns appropriately
• Schedules, prepares for, and attends study initiation meetings, Independent Monitoring Committee (IMC) meetings, monitor visits, and audits
• Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently
• Collection of patient bio specimens and disease activity measures; ensure integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc.)
• Various duties as needed

Study Interactions and Collection

• Attain in-depth understanding of study protocol and objectives to assist with successful implementation of all study procedures
• Demonstrates the ability to create CRFs, study documents, and tools
• Demonstrates ability to resolve complicated queries
• Scheduling and completing subject visits or follow up interactions
• Preparation of datasheets, questionnaires, study related documents as needed
• Tracking and communication with study subjects
• Complete subject documentation and follow up
• Specimen handling, process lab samples, manage laboratory samples and shipping
• Submit Human Subjects Incentive Program (HSIP) requests

Data Entry and Management

• Assist with data entry and capture
• Responsible for data entry and management for study
• Chart abstractions of data to enter in database(s) and source documentation
• Demonstrates ability to resolve complicated queriesTakes an active role in ensuring data quality
• Review collected data and perform data quality assurance of the collected data with the study monitor
• Demonstrates expertise in data collection, data management, and results reporting
• Various duties as needed

Regulatory

• Prepare Institutional Review Board research applications and reporting; update and maintain IRB records
• Facilitate monitoring visits on regulatory compliance
• Facilitate Independent Monitoring Committee meetings
• Add new clinical trials and update existing clinical trials at Clinicaltrials.gov.
• Working with Research Pharmacy, Investigational Product (IP) management and accountability

Supervision Received: This position reports directly to Faculty Principal Investigator.

Supervision Exercised: Could provide Functional supervision (likely in limited capacity such as training) of staff in titles within the CRC Career Ladder.

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.)

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 30,000employees 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 position will be mostly in-person with an expectation of 4-5 days per week onsite.

Underfill Statement

This position may be underfilled at the CRC-Intermediate title based on selected candidates qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

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 maybegin as early as the eighth day after posting.Thisopening 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.