"Clinical Research Coordinator - Associate"

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. This person will be key in providing clinical trial study support and day to day management of multiple investigator-initiated, prospectively enrolling research projects, with the overarching goal of improving maternal and infant health outcomes. This position requires a flexible schedule, with some evening/weekend coverage, and ability to work at various Michigan Medicine locations.

This position will primarily support research for the Cardio-Obstetrics Learning Lab (COLLAB), a program focused on maternal cardiovascular and high-risk obstetrical health research studies.

CRC STATEMENT:

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Associate position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support.

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

Specific duties will include:

Study Interactions and Clinical Coordinator Responsibilities

• Oversee and assist multiple investigators and collaborators
• Work effectively with individuals making a wide range of reproductive health decisions
• Coordinate research efforts with multiple principal investigators, the Cardio-Obstetrics clinic, and research subjects
• Screen, recruit, approach and consent pregnant and postpartum individuals with cardiovascular conditions or elevated cardiovascular risk, giving study overview while being sensitive to environment and patients involved.
• Attain in-depth understanding of cardio-obstetric 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.
• Run protocolized, supervised experiments or assays in a laboratory setting.
• Submit Human Subjects Incentive Program (HSIP) requests
• 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.
• Working with Research Pharmacy in ordering and obtaining study medication
• Travel to various Michigan Medicine sites
• Provide overnight and weekend on-call duties
• Ability to be at work location in less than 45 mins
• Various duties as needed

Data Responsibilities

• Assist in the development of data collection instruments and study specific databases
• Chart abstraction and data entry into various databases
• Triage complex data concerns appropriately
• Routinely monitors integrity, quality, and security of data collection for multiple research databases.
• Resolve data quality queries.
• Assist in analysis.
• Various duties as needed

Regulatory Responsibilities

• Assist PI and study team in submitting and maintaining IRB (eResearch) applications including scheduled continuing reviews and 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.
• Ensure compliance with study protocols, good clinical practice guidelines and FDA regulations
• Assist with any documentation preparation, organization and any regulatory need for institutional and external monitoring visits
• Responsible for maintaining laboratory standards and expectations as well as associated mandatory certifications
• Working with Research Pharmacy, study medication and chain of custody

Other duties as assigned

Required Qualifications:

• 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 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.
• Demonstrate ability to work successfully while meeting competing deadlines
• Flexible work schedule
• Demonstrated ability to prioritize and exercise good judgement
• Demonstrated ability to work effectively with individuals making a wide range of reproductive health decisions
• High attention to detail and accuracy
• Previous experience with chart abstraction and/or data entry
• 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 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

Preferred Qualifications:

• 4+ years of direct related experience
• Experience working with on cardiovascular or maternal health studies
• Previous experience with MIChart/Epic, REDCap, and Qualtrics
• Demonstrates the ability to create and manage databases.
• Familiarity with basic science techniques and specimen processing.
• Exposure to, experience in, and/ or enthusiasm for cardiovascular medicine as it pertains to obstetric populations
• Dedication to the betterment of women’s health through the conduct of rigorous science

Hours: Hours vary depending on the study needs; general hours are usually Monday-Friday within the 7am-5pm range. On call duties require evening and weekend hours with on-call assignments approximately monthly. Must be able to be at work location in less than 45 mins.

Supervision Received: This position reports directly to the COLLAB Principal Investigator and the PRIMO Leadership team