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 Department of Obstetrics and Gynecology seeks an experienced Clinical Research Professional to manage and assist with several gynecology research studies and help grow the GYN Chronic Pain Program. The ideal candidate will have previous research experience in women's health, project management, recruitment, and will serve as a resource and contact person for multiple active research protocols, research sites and staff. In addition to administrative dues, the candidate will engage with patients seen within UofM OBGYN and the community 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 Gynecology. This position requires a flexible schedule, with some evening coverage.

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-Lead 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 world's 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*

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

Specific duties will include:

Project Management and Administrative Responsibilities

* Establishes operational objectives and assignments, and defines and manages project resource needs including project staff.

* 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

* Manage a portfolio of multi-site clinical research, when the University of Michigan is the lead center

* Supports and runs weekly and monthly research meetings

* Reviews study forms, databases, regulatory files, and all study related work for completion and accuracy

* Develops standard operating procedures, work-aids and other guidance

* Creates protocols for specimen collection, processing, shipping, etc., and implements procedures to maintain accuracy and efficiency

* Continually review and evaluate progress of projects and studies in order to identify problems, improve quality and implement solutions or improvements

* Collaborate with PIs, and liaison to Clinical Trial Service Units, on strategic project resource planning including assisting with staff and study need

* Work within CTSU framework for initiating and oversight of multiple studies with billing calendars

* Assist with writing timely reports for funding agencies

* Assist with preparation of power point slides and visual abstracts of research studies related data

* Trains and supports study team members

* Recruit and train appropriate personnel for clinical research

* Provide supervision of students and temporary employees

* Work with administrative units to procure supplies for projects

* Assist PIs and study team members on various duties related to gynecology research as need

* Provide coordination for multiple clinical research studies of various complexity

* Ensure clinical research projects completed within specifications

* Coordinate research efforts with multiple principal investigators, research staff, clinical schedules, and research subjects.

* Communicate with IDS (Research Pharmacy) to order investigational drugs and make sure all protocol supplies are on stock.

* 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

* Investigate, modify, and integrate new procedures as needed

* Serve as primary liaison between study staff, subjects, investigators, other departments, and sponsors.

Clinical Coordination Responsibilities

* Review real time medical records to match potential research participants with inclusion/exclusion criteria for active studies

* Assist with development and implementation of recruitment strategies targeted diverse participants within and outside of Michigan Medicine (including community-based recruitment)

* Travel to various local sites for screening and recruitment

* Approach women in person or on the phone, giving study overview, while being sensitive to environment and patients involved.

* Explain study thoroughly, review informed consent document, answer questions, and obtain consent

* Schedule subject visits, follow up interactions as well as coordinating with PI schedules

* Coordinate subject incentive payment submissions and tracking

* Maintain accurate and complete documents including, but not limited to: source documentation, study drug dispense/return logs, subject logs, and all study-related communications.

* Request and collect specimens, as well as properly prepare and ship specimens to outside institutions according to study protocol requirements.

* Attain in-depth understanding of several study protocols and objectives to assist with successful implementation of all study procedures

* Run and oversee specialized research devices and equipment

Data Related

* Create documents and databases for screening and recruitment

* Prepare datasheets, questionnaires, study related documents

* Complete subject documentation and follow up in online system

* Responsible for data abstraction, entry, management, cleaning and database creation for several studies

* Triage complex data concerns, create reports on the completeness and quality of the collected data

* Various data related duties as needed

Regulatory & Study reporting

* Assist Regulatory specialist in preparing and maintaining, IRB (eResearch) applications including new applications, scheduled continuing reviews, amendments, 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.

* Facilitates monitoring or DSMB meetings

* Schedules, prepares for, and attends study initiation meetings, monitor visits, and audits

* Working with Research Pharmacy, study medication and chain of custody

* Attend and participate in meetings with study team to discuss subject enrollment and issues as well as study progress. Participate in protocol initiation and monitoring visits by study sponsors.

* Assist PI with identifying and grading adverse events.

* Ensure compliance with GCP, ICH, GOG and FDA regulations, standards and guidelines.

* Ensure compliance with study protocols, good clinical practice guidelines and FDA regulations

* Coordinate and facilitate any regulatory and institutional monitoring visits

Training

* Provides training and mentorship of other clinical research staff on a range of communication and teamwork best practices; maintains certification)

* Completes Michigan Medicine training for Managing Successfully and Leading Successfully.

* Attends and participates in all training assigned to this level.

Supervision Received:

This position reports directly to the Department Senior Research Manager and Director of the Endometriosis and Pelvic Pain Research Group.

Supervision Exercised:

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

Required Qualifications*

* Bachelor's degree or an equivalent combination of related education and experience is necessary.