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Clinical Research Coordinator Intermediate

1 month ago

Ann Arbor, United States University of Michigan Full time
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 Program in Research and Innovation on Maternal and Neonatal Outcomes (PRIMO), housed within the Department of Obstetrics and Gynecology seeks an experienced 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 women?s health. 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 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 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.

Mission Statement

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.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the worlds most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

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

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

Study Interactions and Clinical Coordinator Responsibilities

  • Oversee and assist multiple investigators and collaborators on various studies
  • Coordinate research efforts with multiple principal investigators, clinics, and research subjects.
  • 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
  • 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
  • Travel to various Michigan medicine site
  • Train and support team members
  • Various duties as needed

Administrative Responsibilities

  • Coordinate with study teams at other institutions to stay up to date on study protocols and other relevant research tasks for multi-site studies
  • Acts as a liaison or point of contact between investigators, research teams, sponsors, other universities, cooperative groups, other internal and external departments to get questions answered and issues resolved
  • Reviews study forms, databases, regulatory files, and all study related work for completion and accuracy
  • Continually review and evaluate progress of projects and studies in order to identify problems, improve quality and implement solutions or improvements
  • Assist PRIMO leadership team on various duties related to research 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.
  • 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
  • Working with Research Pharmacy, study medication and chain of custody

Supervision Received:

This position reports directly to the PRIMO Leadership team

Supervision Exercised:

Possibly provide Functional supervision, in a limited capacity, such as training of staff in titles within the CRC Career Ladder or temporary and student employees.

Required Qualifications
  • Bachelors 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. 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 3 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.)
  • Demonstrate ability to work successfully while meeting competing deadlines
  • Excellent interpersonal skills
  • Flexible work schedule
  • Demonstrated ability to prioritize and exercise good judgement
  • High attention to detail and accuracy
  • Primary activities are performed independently, and decisions are made free from immediate direction.
  • Excellent communication skills, with the ability to receive and convey information clearly and concisely for various mediums.
  • Excellent interpersonal and organizational skills, and the ability to work effectively with diverse groups
  • A high degree of initiative, resourcefulness and organization skills
  • Demonstrated problem solving, conflict resolution, analytical, and critical thinking skills
  • Demonstrated ability to work well under time constraints and meet deadlines
  • Demonstrated coordination, time management and communication skills
  • Capable of conducting all start up, active implementation, and closeout activities.
  • 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
Desired Qualifications*
  • 6+ years of direct related experience
  • Previous experience in women?s health and/or the field of obstetrics
  • Experience working on multi-site studies
  • Previous experience with MiChart, RedCap, and Qualtrics
  • Demonstrates the ability to create and manage databases.
Work Schedule

M-F; hours vary depending on the study needs; general hours are within the 7am-5pm range with occasional evening hours

Work Locations
  • Coordinator work is currently being conducted on-site
  • Primary location is at the main medical campus in University Hospital South (UH South); with regular work activities at VonVoightlander Womens Hospital, West Ann Arbor and other Michigan Medicine locations within Ann Arbor.
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.

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.

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