Clinical Research Coordinator

Clinical Research Coordinator 
Kalamazoo, MI 
Onsite 
Full-Time 

Responsibilities :
Prepare, submit, and monitor documentation for research programs.
Ensure compliance with research regulations and protocols through audits.
Advise caregivers on program design, treatment administration, and patient follow-up.
Organize study files, including regulatory binders and source documentation.
Maintain and update study files and records according to sponsor and institutional requirements.
Review, edit, and update informed consent documents for clinical trials.
Collaborate with the Principal Investigator (PI) to prepare IRB and regulatory submissions.
Assist in reviewing eligibility criteria for participant enrollment.
Coordinate enrollment of participants into Children's Oncology Group (COG) studies.
Develop familiarity with COG protocols and specimen submission guidelines.
Collect study data and ensure timely completion of Case Report Forms.
Coordinate audits with the central COG office and maintain audit readiness.
Perform additional duties as assigned.

Required Skills :
Must have previous experience with COG - 2 years
Bachelor's degree in a scientific or healthcare field, or equivalent experience in Data entry, Research, Healthcare administration education in the protection of human research participants and Good Clinical Practices required.
Current clinical licensure and board certifications:
SOCRA (preferred)
ACRP (preferred within 4 years of hire)
CITI training
Human protections training
IATA certification for shipping infectious substances and diagnostic specimens.
Ability to read and interpret:
Research documents
Clinical trial documents
Operating and maintenance instructions
Procedure manuals
Strong written and verbal communication skills.
Excellent interpersonal and relationship-building skills