"Clinical Research Coord Inter TERM-LIMITED"

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.

We are seeking a responsible, motivated, individual who will independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this clinical research coordinator (CRC) position may help support a portfolio of projects with varying levels of 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. This position has a term limitation of 2 years, with an option to extend if funds are available.

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

Responsibilities:

• Manages and coordinates all aspects of assigned clinical research portfolio including but not limited to: Regulatory submissions, creation/maintenance of regulatory binders; Subject screening, consenting, enrollment, management of study records; Data collection, entry, sharing, storage, management, query resolution; Create and complete case report forms, source documentation, study documents and tools; Database/survey development in various electronic platforms (REDCap, Qualtrics); Effectively communicate with sponsors; coordinate, prepare, and attend visits for site initiation, monitoring, auditing, and/or closeout; Assess studies for execution and troubleshoot potential implementation issues; Provide cross-coverage on projects
• Performs study procedures with accuracy
• Demonstrates ability to triage complex study concerns appropriately
• Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently
• Contributes to the development of processes and tools to capture data in accordance with ALCOA-C principles
• Resolves complicated queries
• Demonstrates an understanding of Investigational products development process and applies key regulatory requirements to control these processes
• Monitors site compliance with subject safety reporting, escalates issues, and contributes to the development of tools and processes to enhance subject safety during the conduct of a clinical study
• Provides logistic and regulation guidance on Investigator Initiated Studies for adherence to University and Federal guidelines
• Provide other administrative support for study activity including management of subject reimbursement and payments
• Participates in trainings specifically for maintaining certification as a Clinical Research Professional

Required Qualifications:

• 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. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed within six months of date of hire.
• Minimum 3 years of directly related experience in clinical research and clinical trials is necessary.
• Excellent organizational skills and attention to detail.
• Superb interpersonal skills - comfortable speaking with healthcare providers, research sponsors, and patients.
• Ability to communicate effectively and professionally in both verbal and written form.
• Ability to work independently but also within a team.
• Ability to prioritize multiple tasks and meet deadlines are a must.

Desired Qualifications:

• 6+ years of direct related experience
• Excellent communication skills
• Ability to foresee needs of investigators/study teams and respond accordingly
• Possess critical thinking skills
• Ability to triage complex study concerns appropriately

This is a full-time regular position. Monday-Friday: 8am-4:30pm; On-site work required. Travel to satellite clinics may be required.

This is a term-limited appointment for 2 years, with an option to extend if funds are available.