Clinical Research Coordinator Intermediate

University Of Michigan; Ann Arbor (MI); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Excellent medical, dental and vision

2:1 retirement match

Job summary

University of Michigan is seeking an experienced Clinical Research Coordinator at the Intermediate level to support a longitudinal cohort of autoimmune disease studies and translational trials. You will work with a clinical research team and program manager to coordinate study start-up through close-out, including IRB submissions and consent processes.

You will oversee data management, sample handling, and participant visits while contributing to SOP development and training.

Qualifications

• Bachelor's degree in Health Science or an equivalent combination of related education and experience.
• Certification through ACRP (CCRC) or SoCRA (CCRP) or equivalent, with eligibility to register or take exam within six months of hire.
• IRB/Regulatory knowledge including initial submissions and amendments, with strong interpersonal and organizational skills.
• Ability to work independently with attention to detail and high organizational standards.
• Experience with data entry into eCRF systems (REDCap, iMedidata, etc.).
• Ability to collaborate with a multidisciplinary team in outpatient/inpatient settings and understand CFR, GCP, FDA regulations.

Responsibilities

• Coordinate multiple clinical studies from start-up to close-out in accordance with protocols and regulations.
• Prepare and submit IRB applications and informed consent documents.
• Screen and enroll eligible participants and obtain informed consent.
• Coordinate participant visits, assessments, and research activities per protocols.
• Coordinate collection, processing, storage, and shipment of study samples.
• Process participant payments and maintain documentation related to compensation.
• Develop and maintain SOPs and study-specific resources.
• Manage study data collection, entry, review, and reconciliation; resolve data queries.
• Serve as primary contact for participants, investigators, monitors, and stakeholders.
• Maintain accurate study records; support study closeout activities.

Skills

Independent worker

Excellent communication

Multitasking

Detail oriented

Record keeping

Education

Bachelor's degree in Health Science or related field

Tools

REDCap

iMedidata

EPIC

MiChart

eResearch systems

OnCore CTMS

Job description

Clinical Research Coordinator Intermediate

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A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

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 an experienced, independent, positive, organized individual with excellent record-keeping and communication skills as a Clinical Research Coordinator Intermediate at the University of Michigan. The job will involve working with a clinical research team and program manager to maintain a large, longitudinal cohort of skin and systemic autoimmune diseases and to launch and coordinate translational and clinical research trials.

This position will involve working with patients diagnosed with autoimmune disease.

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any 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.

Responsibilities*

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
• Coordinate the overall conduct of multiple clinical research studies from study start-up through close-out, ensuring activities are completed in accordance with study protocols, applicable regulations, and institutional requirements.
• Manage study start-up and initiation activities, including preparation and submission of initial IRB applications, informed consent documents, and other required study materials.
• Screen and enroll eligible study participants and obtain informed consent in accordance with approved protocols and regulatory requirements.
• Coordinate and conduct participant visits, study assessments, and other research-related activities as required by study protocols.
• Coordinate the collection, processing, storage, and shipment of study samples in accordance with protocol and laboratory requirements.
• Process participant payments and maintain accurate documentation related to study compensation.
• Prepare for and support study closeout activities, ensuring required documentation and study materials are complete and properly maintained.
• Develop and maintain study-specific resources, tools, and standard operating procedures (SOPs) as needed.
• Manage study data, including data collection, entry, review, and reconciliation, and ensure timely resolution of data queries.
• Serve as the primary point of contact for study participants, investigators, study monitors, and other research stakeholders.
• Maintain accurate and complete study records and documentation throughout the duration of each study.
• Perform other administrative and research-related duties as assigned.

The position will interface with clinical research teams in Dermatology and Rheumatology. Opportunities for growth include expansion of clinical trial work, supervision of junior coordinators and advancement through the Clinical Research Coordinator Career Ladder.

Supervision Received: This position reports directly to Faculty Principal Investigator, Dr. J. Michelle Kahlenberg

Supervision Exercised: No supervison exercised at this time beyond helping students.

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.)
• IRB/Regulatory knowledge including initial submissions and amendments. Excellent interpersonal and organizational skills.
• Demonstrate a strong attention to detail and work well independently
• Ability to multi-task and sustain a high level of organization while working on several research studies
• Excellent communication skills, both written and oral
• Experience with data entry into eCRF systems (REDCap, iMedidata, etc.)
• Ability to work with a multidisciplinary team of physicians, scientists, nurses and medical assistants in an outpatient/inpatient clinical setting.
• Must understand challenges and regulations regarding human subject's research. The candidate must feel comfortable working with patients and communicating scientific/technical language. Demonstrated understanding of clinical research; understanding compliance issues related to human subject research, knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations

Desired Qualifications*

6+ years of direct related experience

• SOCRA certified or willingness to obtain certification upon hire. REDCap programming knowledge
• A working knowledge of basic medical terminology
• Experience with EPIC, MiChart, eResearch systems
• Experience with the OnCore clinical trial management system (CTMS)
• Prior job experience interacting with patients in a direct patient care setting or outpatient clinic

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 30,000employees 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

Monday-Friday from 8-5, 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.

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Working Title

Clinical Research Coordinator Intermediate