Clinical Research Coordinator Associate/Technician

University Of Michigan - Ann Arbor, MI

Full-time - Entry Level

Ann Arbor, MI

10,001+ employees

Educational Services

About the position

The Program in Research and Innovation on Maternal and Neonatal Outcomes (PRIMO), part of the Department of Obstetrics and Gynecology, is seeking a Clinical Research Coordinator Associate/Technician to join our dynamic obstetrics research team. This role is pivotal in supporting various maternal and obstetrical health research studies, requiring a candidate with prior research experience in women's health. The Clinical Research Coordinator will be instrumental in providing clinical trial study support and managing multiple research projects aimed at enhancing the health of women and infants. The position demands a flexible schedule, including some evening and weekend work, and the ability to operate across various Michigan Medicine locations. As a Clinical Research Coordinator, the individual will be responsible for coordinating multiple clinical research studies, which may vary in complexity from moderate to complex. The candidate is expected to have a comprehensive understanding of all job duties associated with the CRC-Technician position on the Michigan Medicine CRC Career Ladder. This role requires the ability to perform tasks independently, make informed decisions, and demonstrate a moderate level of expertise across all relevant skills and abilities, ensuring high-quality work. The coordinator will utilize available resources effectively, operate e-clinical technologies proficiently, and conduct quality checks on their work. Key competencies include demonstrating, implementing, executing, and utilizing various skills effectively. Michigan Medicine is one of the largest healthcare complexes globally, known for its groundbreaking medical and technological advancements. With over 30,000 employees, the institution aims to attract, inspire, and develop exceptional talent in medicine, sciences, and healthcare, contributing to its vision of becoming one of the world's most distinguished academic health systems. Every team member plays a role in advancing this world-class institution, making it a rewarding place to work. The Clinical Research Coordinator will engage in various responsibilities, including patient recruitment, study protocol implementation, data management, and regulatory compliance. The role also involves collaboration with medical staff to optimize patient care and ensure adherence to study protocols and good clinical practice guidelines. The coordinator will be responsible for data entry, management, and quality assurance, as well as assisting with IRB applications and adverse event reporting. This position is essential for the successful execution of clinical research studies and the advancement of maternal and neonatal health outcomes.

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.
• Explain studies thoroughly, review informed consent, answer questions and follow GCP/IRB and obtain consent.
• Execute study visits and study related procedures.
• Triage complex study concerns appropriately.
• Collect 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.
• Collaborate 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.
• Work with Research Pharmacy in ordering and obtaining study medication.
• Travel to various Michigan Medicine sites as needed.

Requirements

• 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.
• Minimum 2 years of directly related experience in clinical research and clinical trials is necessary.
• Previous experience with chart abstraction and/or data entry is required.
• Excellent verbal and written communication skills are necessary.
• Excellent interpersonal and organizational skills, and the ability to work effectively with diverse groups are essential.
• Demonstrated ability to work well under time constraints and meet deadlines is required.
• Demonstrated ability to prioritize and exercise good judgement is necessary.
• High attention to detail and accuracy is essential.
• Demonstrated ability to work independently with minimal supervision as well as work as part of a team is required.
• Demonstrated problem solving, conflict resolution, analytical, and critical thinking skills are necessary.
• Demonstrated coordination, time management and communication skills are essential.
• Personal transportation to support various work locations is required.

Nice-to-haves

• 4+ years of direct related experience is preferred.
• 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.
• Previous experience in women's health and/or a maternal population is preferred.
• Experience with the OnCore clinical trial management system (CTMS) is desirable.
• Previous experience with MiChart, RedCap, and Qualtrics is preferred.
• Previous experience with sample processing and shipping is desirable.

Benefits

• Excellent medical, dental and vision coverage effective on your very first day.
• 2:1 Match on retirement savings.