Clinical Research Coordinator Intermediate

Clinical Research Coordinator

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:

1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. 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 queries
• Takes 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.)
• 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.)

Desired Qualifications

• 6+ years of direct related experience

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 worlds 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.

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.