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 Program in Research and Innovation on Maternal and Neonatal Outcomes (PRIMO), housed within the Department of Obstetrics and Gynecology seeks a Clinical Research Coordinator to join our fast-growing obstetrics research team. The ideal candidate will assist with several maternal and obstetrical health research studies and have previous research experience in womens' health research. This person will be key in providing clinical trial study support and day to day management of multiple research projects focused on improving women and infant health. This position requires a flexible schedule, with some evening and weekend coverage, and ability to work at various Michigan Medicine locations. 

CRC STATEMENT:

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.

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.

Characteristic Duties and Responsibilities:

Expert level 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

Additional duties will include:

Study Interactions and Clinical Coordinator Responsibilities

• Assist multiple investigators and collaborators to monitor patient recruitment and develop plans to enhance recruitment
• Screen, recruit, approach and consent pregnant women, giving study overview while being sensitive to environment and patients involved.
• Attain in-depth understanding of study protocol and objectives to assist with successful implementation of all study procedures
• Explaining studies thoroughly, reviewing informed consent, answering questions and following GCP/IRB and obtaining consent
• Execute study visits and study related procedures
• Triage complex study concerns appropriately
• Collect of human biospecimens, as well as processing, preparing and shipping specimens to outside institutions according to study protocol requirements.
• Submit Human Subjects Incentive Program (HSIP) requests
• Coordinate with study teams at other institutions to stay up to date on study protocols and other relevant research tasks for multi-site studies
• Collaborates with medical staff to facilitate and optimize the care of research patients
• Develop and monitor protocols and infrastructure for clinical studies
• Track, document and report on study progress
• Review real time medical records to match potential research participants with inclusion/exclusion criteria for active studies
• Schedule subject visits and follow up interactions by facilitating communication between clinic/unit staff and investigators/study team
• Perform study-specific testing and oversee specialized research devices and equipment 
• Investigate, modify, and integrate new procedures as needed
• Serve as primary liaison between study staff, subjects, investigators, other departments, and sponsors.
• Working with Research Pharmacy in ordering and obtaining study medication
• Travelling to various Michigan medicine site
• Assist in conducting individual and group interviews
• Various duties as needed

Data Related

• 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
• Triage complex data concerns appropriately
• 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
• Assist with quantitative and qualitative analysis

Regulatory & Study reporting

• Assist PI and study team 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 and external monitoring visits

Other duties as assigned

• Bachelor's degree 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 2 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.)  
• At least 1 year of experience working with a maternal population
• 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 independently with minimal supervision as well as work as part of a team. 
• Demonstrated problem solving, conflict resolution, analytical, and critical thinking skills
• Demonstrated coordination, time management and communication skills
• Demonstrated ability to perform the majority of tasks independently and perform quality checks of their work
• Personal transportation to support various work locations

• 4+ years of direct related experience
• Doula certified
• Experience with the OnCore clinical trial management system (CTMS)
• Previous experience with MiChart, RedCap, or 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. 

• Primary location is at the main medical campus in University Hospital South (UH South); with regular work activities at VonVoigtlander Women's Hospital. 
• This position may include some travel to Michigan Medicine clinical sites such as West Ann Arbor.

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.

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.

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.