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 anesthesiology department is seeking a highly motivated and friendly individual to join the Michigan Perioperative Pain Research (MPR) team as a clinical research coordinator. The MPR is a fast-paced, dynamic group that has several projects ranging from investigator initiated to sponsor funded (NIH, PCORI). Emphasis is placed on maintaining a positive work environment, fostering comradery, and encouraging professional development. Our mission is to better understand the transition to acute to chronic pain, perioperative outcomes, and post-operative pain management. This work will transform care, while dedication to our guiding principles enriches the lives of our team members and those in the community.
This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. 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.
Responsibilities*
Independent knowledge, skills, and abilities within 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
Study Duties
- Oversee and complete all aspects of clinical study coordination including: identifying and screening potential subjects, consenting and enrolling subjects, and coordinating participant study visits/data collection.
- Serve as a resource and train research staff in performing specified job duties as specified by the project and/or program manager.
- Assist in developing improved work flows and source documents as needed.
- Maintain source documents for accurate tracking, collection and recording of data.
- Perform data collection and entry into study databases.
- Perform recruitment activities at on and off-site UM locations.
- Utilizes critical thinking skills to recognize and solve patient/participant problems.
- Achieve proficiency in working with study databases. Be able to run reports, enter participant data into CRFs, abstract data from the EHR, distribute surveys in a timely manner and correctly.
- Keep study correspondences and documents organized. Ensure changes are implemented in study procedures and workflows as needed.
- Assist in preparation of reports for meetings and slide material for data presentations as specified by the project and/or program manager.
- Assist with adherence to project timeline and milestones.
Regulatory Duties
- Ability to identify and expeditiously report Adverse Events (AEs) and Serious Adverse Events (SAEs) to the project manager, program manager and PI.
- Assist with IRB submissions as needed.
- Conduct data cleaning as specified in the study protocol.
- Attain an in-depth understanding of the study/grant protocols and objectives to assist with their successful implementation.
General/Miscellaneous
- Staff members are expected to work independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while maintaining the strictest of confidentiality at all times.
- Other tasks as defined by project and/or program manager.
Required Qualifications*
CRC-Assoc
- Bachelor's degree in Health Science or an equivalent combination of related education and experience.
- 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)
- Minimum 2 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
- Understanding of some medical terminology.
- Ability to organize and manage multiple tasks simultaneously, as well as prioritize and exercise good judgment. This position requires the highest levels of integrity, attention to detail, resourcefulness and time management skills.
- Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner.
- Ability to provide a high level of customer service to patients, visitors, staff, and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem-solving.
- Ability to anticipate and plan for potential problems and formulate pragmatic solutions.
- Ability to remain calm in stressful situations.
- Eager to learn new skills and develop competencies within clinical research.
CRC-Tech
- Associate degree in Health Science or an equivalent combination of related education and experience.
- ONE of the following:
- Minimum 1 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
- 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.
- 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.
- Ability to work independently with diverse teams of people in a diplomatic, collaborative and effective manner.
- Ability to provide a high level of customer service to patients, visitors, staff, and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem-solving.
- Eager to learn new skills and develop competencies within clinical research.
CRC - Asst
- High school diploma or GED is necessary.
- Eager to learn new skills and develop competencies within clinical research.
- Ability to provide a high level of customer service to patients, visitors, staff.
- Ability to work independently with diverse teams of people.
Desired Qualifications*
CRC-Assoc
- 4+ years of direct related experience
- 1+ years of supervisory experience.
- Experience with project management.
- Experience with investigator-initiated and federally sponsored studies.
- Knowledge of UMHS policies and practice.
- Familiarity with OnCore, Epic, MiChart, MyDataHelps Designer, Qualtrics, LabVantage and eResearch applications.
- PEERRS, CITI, or NIH Protection of Human Subjects Training Certification.
CRC-Tech
- Bachelor's 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.
- PEERRS, CITI, or NIH Protection of Human Subjects Training Certification.
- Familiarity with OnCore, Epic, MiChart, MyDataHelps Designer, Qualtrics, LabVantage and eResearch applications.
CRC-Asst
- Associate 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.
- PEERRS, CITI, or NIH Protection of Human Subjects Training Certification.
Work Locations
UH South, F7520
Underfill Statement
This position may be underfilled at the CRC-Technician or CRC-Assistant titles based on selected candidates qualifications.
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.
This position is term-limited for 2 years with the possibility of renewal based on need and available funding. At the end of the stated term, your appointment will terminate, and will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct.
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.