"Clinical Research Coord Assoc"

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 Department of Obstetrics and Gynecology seeks a qualified candidate to assist on reproductive health services projects, primarily supporting the GRASP project for women aged 21–39. The ideal candidate will facilitate patient family history tools during cervical cancer screenings, coordinate automated result communication, and connect at-risk patients to genetic counseling. Requires flexible hours (including some evenings/weekends) and ability to work at various Michigan Medicine locations.

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.

Responsibilities

Characteristic Duties and Responsibilities:

Independent 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

• Monitor patient recruitment and develop plans to optimize it
• Work with the interprofessional team and community organizations
• Screen, recruit, and consent participants; execute study visits/procedures
• Collect/process biospecimens and coordinate with study teams
• Review medical records for eligibility; schedule visits; oversee study equipment
• Serve as liaison between staff, subjects, investigators, sponsors
• Assist with interviews, focus groups, and provide on-call duties
• Actively engage, screen, and recruit study participants at participating sites.
• Collaborate with medical staff at study sites to facilitate and optimize the care of research patients.
• Facilitate communication between clinic staff and study surveyors.
• Reports on recruitment, testing, data, and projects during team meetings

Administrative Responsibilities

• Lead qualitative studies on breast cancer risk in young communities
• Serve as Patient Navigator for GRASP; organize provider training and follow-up
• Assist with daily tasks and communication to providers
• Manage patient reimbursements for survey completion

Data Related

• Attend and participate in meetings with the study team to discuss subject enrollment and issues as well as study progress. Participate in protocol initiation and monitoring visits by study sponsors.
• Responsible for data, collection, entry, and management for study
• Review collected data and performed data quality assurance of the collected data with the study monitor and statistician(s)
• Assist with preparing tables, charts, and graphs and editing manuscripts/presentations/sponsor reports
• Creates agenda for meetings and takes meeting minutes.
• Collect/manage study data, ensure quality assurance
• Collaborate with genetic counselors and submit participant compensation
• Assist with data analysis and reports; prepare charts, tables, and manuscripts/presentations
• Take meeting minutes and coordinate with team
• Various duties as needed

Regulatory & Study reporting

• Assist PI and study team in maintaining IRB (eResearch) applications including scheduled continuing reviews, adverse event reporting (events that either occur 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 and external monitor visits.
• Ensure compliance with study protocols, good clinical practice guidelines and FDA regulations

Information Dissemination:

• Approach women in person, giving study overview while being sensitive to the environment and patients involved.
• Provide information about the project, answer questions, and address concerns of potential participants.

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 3 years of directly related experience in clinical research and clinical trials is necessary.
• 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

Level Specific Requirements:

Minimum 3 years of directly related experience in clinical research and clinical trials is necessary.

• 4+ years of direct related experience
• Previous experience in women's health research
• Master's degree in public health or related field
• Previous experience in breast cancer research
• Previous experience with genetic testing software
• Previous experience with MiChart, RedCap, and Qualtrics
• Previous experience with survey research
• Experience with qualitative and quantitative research methods
• Demonstrates the ability to create and manage databases.

Hours: Hours vary depending on the study needs; general hours are usually Monday-Friday within the 7am-5pm range and some weekends depending on the research needs.