How to Apply
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.
Summary
The Department of Surgery is seeking an experienced Clinical Research Coordinator (CRC) to assist with multiple study projects, in all aspects of clinical research including study planning, start up, IRB management, regulatory management, identifying and screening study patients, consenting and enrolling participants, study visit management, as well as data collection.
Responsibilities*
The Clinical Research Coordinator (CRC) will be responsible for the meticulous conduct of both interventional and observational clinical research studies, including pharmaceutical, industry sponsored trials. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.
Clinical Coordinator Responsibilities: (ex. Develops processes, tools, and training to support related activities associated with study execution; Performs study procedures at the highest levels and mentors team members in accurate completion of study procedures; Develops processes and tools, and mentors study team in best practices for addressing subject concerns efficiently)
- Demonstrates understanding of protocol elements/requirements and demonstrate the ability to execute study procedures.
- Demonstrates the ability to anticipate and mitigate the potential for protocol non-compliance.
- Describes protocol structure and explains how to interpret study requirements to ensure study compliance.
- Demonstrates accurate implementation of protocol procedures.
- Explains and performs study non-GCP related study management activities.
- Performs study procedures with minimal supervision.
- Triages simple subject concerns and issues appropriately.
- Schedules, assists with preparation for, and attends study initiation meetings, monitor visits, and audits.
- Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.).
- Comfortable with basic clinical lab equipment such as a centrifuge, various freezers, pipettes, and standard laboratory safety requirements and guidelines.
- Explains the role of the Clinical Trial Support Unit (CTSU) for initiating new studies, and for subject visit billing.
Data Coordinator Responsibilities: (ex. Oversees data quality; Performs at the highest level of data management and results reporting)
- Demonstrates the ability to document data in accordance with ALCOA-C principles.
- Explains how to utilize information from the EMR and study databases.
- Completes complex data collection during study visits.
- Demonstrates ability to resolve data queries.
Regulatory Coordinator Responsibilities: (ex. 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; Oversees regulatory documentation for quality assurance; Develops processes, tools, and training to enhance site compliance with the requirements necessary for the safe and effective development of investigational products)
- Explains and performs study operational activities in compliance with Good Clinical Practice (GCP)
- Explains proper documentation techniques as outlined in the ICH-GCP guidelines.
- Explains the difference between Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs), can appropriately identify them and report them.
- Works with the Office of Research Compliance Review to create and post studies in ClinicalTrials.gov and obtain the NCT.
- Demonstrates understanding of University and Federal guidelines in order to assist with Investigator Initiated studies.
- Collaborates with MIAP for INDs and IDEs.
- Demonstrates an understanding of the elements of subject safety, related documentation, and reporting. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.
- Demonstrates proficiency in all eResearch applications and submissions, such as continuing renewals and amendments.
- Demonstrates ability to maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
- Maintenance of updated regulatory documentation.
- Explain the investigational products development process and identify key regulations to control these processes
Training: (ex. Provides training and mentorship of other clinical research staff on a range of communication and teamwork best practices; maintain certification)
- All training requirements of previous level.
- Develops and conducts training for staff and others.
- Attends and participates in all training assigned to this level.
Supervision Received: Director of Clinical Operations
Supervision Exercised: None
Required Qualifications*
CRC Associate:
- Bachelors degree or equivalent combination of education and experience; Health Science preferred
- 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 2 years of directly related experience in clinical research and clinical trials is necessary. (Please review SOCRAs definition of a Clinical Research Professional for qualifying experience prior to applying.)
CRC Technician:
- Associate degree in Health Science or an equivalent combination of related education and experience is necessary.
- Minimum 1 year of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.) or An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD. or Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.
Both:
- Prior experience writing and maintaining IRB submissions, including initial applications, continuing reviews, amendments, and adverse events;
- Prior experience collecting and maintaining regulatory documentation;
- Proficiency in working with electronic medical records;
- Knowledge of and experience with ethical and regulatory aspects of medical research and appropriate conduct of clinical trials, including The Code of Federal Regulations (CFR) and Good Clinical Practice (GCP);
- Ability to create source documents, to track protocol-required data points;
- Ability to communicate professionally and interact effectively with patients, faculty, staff, and others; teamwork is a critical component of this position;
- Ability to work independently, think critically, prioritize, and exercise good judgement;
- Desire to work in a fast paced, patient oriented environment to further scientific knowledge;
- Positive attitude and desire to continually learn and grow professionally;
- Exceptional customer service abilities
Desired Qualifications*
Associate Level:
- 4+ years of direct related experience
Technician Level:
- Bachelors degree in Health Science or an equivalent combination of related education and experience is desirable.
- An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.
Both:
- Knowledge of Michigan Medicine policies and practice;
- Experience in leadership roles.
Work Schedule
- Coordinator work is currently being conducted in on site at Taubman and Cancer Center. There will be potential for a hybrid model in the future with a mixture of remote and on-site work as needed to perform the requirements of the role while maintaining high quality and service level to principal investigators and patients.
- Normal work schedule is 8 a.m. to 4:30 p.m., Monday through Friday.
Underfill Statement
This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.
Additional Information
Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.
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/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.