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.
The Department of Obstetrics and Gynecology seeks a Clinical Research Coordinator to assist with several maternal and obstetrical health research studies.The ideal candidate will have previous research experience in women's health and will serve as a resource and contact person for multiple active research protocols. The candidate will approach pregnant and laboring women for recruitment, enrollment, specimen and data collection in studies; capture data from medical records and enter into various data systems; communicate with patients regarding study purpose, study activities, and research appointments; create documents for accurate tracking and support faculty and fellows in the Division of Maternal Fetal Medicine. This position requires a flexible schedule, with some evening and weekend coverage.
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.
Characteristic Duties and Responsibilities:
Expert level knowledge, skills, and abilities within 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
Additional duties will include:
Study Interactions and Clinical Coordinator Responsibilities
Attain in-depth understanding of study protocol and objectives to assist with successful implementation of all study procedures
Coordinate research efforts with multiple principal investigators, clinics, and research subjects.
Review real time medical records to match potential research participants with inclusion/exclusion criteria for active studies
Screen, recruit and approach pregnant women, giving study overview while being sensitive to environment and patients involved.
Schedule subject visits and follow up interactions by facilitating communication between clinic/unit staff and investigators/study team
Run and oversee specialized research devices and equipment
Working with Research Pharmacy in ordering and obtaining study medication
Request and collect pathology specimens, as well as processing and prepare and ship specimens to outside institutions according to study protocol requirements.
Create case report forms, questionnaires and study related documents
Complete study documentation in various data systems
Responsible for data entry, management, cleaning and database creation for several studies
Abstract data from the medical record
Review collected data and perform data quality assurance of the collected data
Create reports on the completeness and quality of the collected data
Regulatory & Study reporting
Assist MFM Research Project Manager in maintaining IRB (eResearch) applications including scheduled continuing reviews, adverse event reporting (events that either occurs in UM research subjects or subjects from other centers in multi-site studies) and other reportable information and occurrences.
Assist PI with identifying and grading adverse events.
Ensure compliance with study protocols, good clinical practice guidelines and FDA regulations
Assist with any regulatory and institutional monitoring visits
Other duties as assigned
Various duties as needed
This position reports directly to a CRC-Lead, CRC-Project Manager, a unit Administrator, Director, or Faculty Principal Investigator.
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) and must be achieved by 01/01/24.After 01/01/24, certification is required within six months of date of hire.
Minimum 2 years of directly related experience in clinical research and clinical trials is necessary.
Previous experience with chart abstraction and/or data entry
Flexible work schedule
Excellent verbal and written communication skills
Excellent interpersonal and organizational skills, and the ability to work effectively with diverse groups
Demonstrated ability to work well under time constraints and meet deadlines
Demonstrated ability to prioritize and exercise good judgement
High attention to detail and accuracy
Demonstrated ability to work with minimal supervision and to work independently as well as part of a team
Demonstrated problem solving, conflict resolution, analytical, and critical thinking skills
Demonstrated coordination, time management and communication skills
4+ years of direct related experience
Previous experience in women?s health and/or a maternal population
Experience with the OnCore clinical trial management system (CTMS)
Previous experience with MiChart, RedCap, and Qualtrics
Previous experience with sample processing and shipping
General hours are Mon-Fri within the 7am-5pm range. Some evening (5pm-9pm) and weekend hours may be required depending on the study needs.
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.
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.
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 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.
The University of Michigan is an equal opportunity/affirmative action employer.
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.