Clinical Research Coordinator

Clinical Research Coordinator

Software Guidance & Assistance, Inc., (SGA), is searching for a Clinical Research Coordinator for a Contract to hire assignment with one of our premier Healthcare clients in Kalamazoo, MI. 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 - 5 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

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work.