Western Michigan University Homer Stryker M.D. School of Medicine is seeking a Research Navigator for the Center for Clinical Research Program. The Research Navigator serves as a resource to WMed researchers (students, residents, and faculty) initiating investigator-led research studies. The Navigator is the first point of contact within the Office of Research and guides the investigator throughout the lifecycle of a protocol.  The Research Navigator collaborates with research service providers throughout WMed to ensure the efficient and logical workflow needed for successful research projects. This individual assists investigators in preparing timelines, identifying the research resources needed for planning and execution of research projects, referring investigators to the appropriate services, and assists in the regulatory submission process.  This individual will query active researchers regarding ongoing research projects and disseminate that information to medical students, graduate students, and residents and assist in pairing students and residents with researchers. 

• Serves as gatekeeper and liaison for investigators requesting research support services within WMed. Support service providers include but are not limited to CCR staff, bioinformatics, medical librarians, faculty advisors, IACUC, IBC, and IRB administrative staff.
• Facilitates project kick-off meeting with investigators to determine project scope and feasibility. This may include working with the hospital affiliates to assist with institutional approval.
• Develops study timelines and establishes realistic expectations for study milestones. Updates timeline as needed during the life-cycle of the project.
• Reviews and provides feedback on operational and regulatory aspects of the study design and protocol.
• Tracks project requests, feedback, and other inquiries to ensure timely project development.
• Identifies research gaps/challenges and participates in process improvement projects.
• Advises and assists on initial and subsequent regulatory (IACUC, IRB, Biosafety) submissions.
• Instructs investigators on requirements for research study files and archiving.
• Assists in disseminating information on research processes to WMed students (medical and graduate), residents, faculty, and staff.
• Availability to work on weekends or evenings to complete time sensitive projects.
• Acquires knowledge for new technology and policy/procedure revisions.
• Oversee web site research content and ensure that the information provided is current.
• Assists with special initiatives and projects as needed.
• All other duties as assigned.

EDUCATION AND/OR EXPERIENCE: 

• Bachelor's degree in Nursing, Biomedical Science, or related field required
• Minimum of 3 years of experience in academic, hospital, or pharmaceutical clinical research including protocol development or project management experience required
• Experience preparing IRB submissions and compliance with regulatory requirements for research

LICENSES, REGISTRATIONS, CERTIFICATIONS: 

• Certification as Clinical Research Coordinator (CRC), Clinical Research Associate (CRA), or Certified IRB Professional (CIP) desirable.
• Training in Protection of Human Subjects and Good Clinical Practice required.  

OTHER SKILLS AND ABILITIES: 

• Must have the ability to analyze and interpret complex information.
• Understands scientific vocabulary necessary to interact with faculty, staff and students.
• Communicates effectively on all levels both orally and in writing.
• High level of organizational skills and ability to concurrently manage multiple tasks.
• Meticulous attention to detail and data integrity.
• Ability to manage multiple priorities and deliver results to meet assigned deadlines.
• Demonstrates the ability to recognize priorities in organization of work flow.
• Able to perform duties independently, with a minimal need for direct supervision.

PREFERRED QUALIFICATIONS:

• Knowledgeable in Federal, State and local regulations and guidelines for the conduct of human subject and animal research.
• Experience preparing applications and other documents for submission to Institutional Review Boards (IRB) and/or Institutional Animal Care and Use Committees (IACUC).
• Experience in investigator or research site training.
• Working knowledge of scientific and medical concepts, terminology and clinical care procedures and standards.
• Computer proficiency including MS Office Suite (MS Word, Excel, PowerPoint) and other database programs.
• Strong working knowledge of HIPAA, PHI, personal identifiable information, EMR, databases, and medical record documentation.
• Demonstrates the ability to recognize priorities in organization of workflow.
• Able to perform duties independently, with a minimal need for direct supervision.