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. Please find us at . SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy.
