Clinical Research Coordinator - Full time, 40 hours per week - Pediatric Hematology/Oncology - ON SITE Kalamazoo, MI

Team Bronson is compassionate, resilient and strong. We are driven by Positivity which inspires us to be our best and to go above and beyond for our patients, for one another, and for our community.

About the role

The Clinical Research Coordinator prepares, submits and monitors documentation of research programs at a dedicated advanced medical facility and assures compliance with regulations and protocols through process audits. The Clinical Research Coordinator also advises caregivers regarding program design, treatment administration and patient follow-up. Employees providing direct patient care must demonstrate competencies specific to the population served.

Responsibilities

• Establish and organize study files, including regulatory binders and study specific source documentations
• Maintain and update study files and retain all study records in accordance with sponsor requirements and institutional policies
• Review, edit, and update scientific consent documents specific to each clinical trial
• Collaborate with the PI to prepare the IRB and other regulatory submission documents
• Assist in the review of eligibility criteria for subject enrollment
• Coordinate the enrollment of participants into COG studies
• Review and develop a familiarity with COG protocols following study guidelines for specimen submission
• Collect data as required by the protocol and assure timely completion of Case Report Forms
• Coordinate Audit with Central COG office and maintain a readiness for that audit
• Other Duties as assigned

Requirements

• Bachelor's degree in scientific, healthcare, or equivalent field or equivalent experience in data entry, research or healthcare administration required
• Education in the protection of human research participants and Good Clinical Practices required
• Current clinical licensing and board certification required, if applicable
• Professional certification (SOCRA or ACRP) preferred within 4 years of date of hire
• IATA Certification for shipping infectious substances and diagnostic specimens
• Ability to read and interpret research and clinical trial documents, operating and maintenance instructions, and procedure manuals
• Advanced written and verbal communication skills
• Excellent interpersonal and human relations skills and the ability to work constructively with physicians, their offices, sponsors and Bronson employees
• Self directed with strong analytical and problem solving skills
• Ability to work effectively and efficiently under tight deadlines, high volumes and multiple interruptions with precision and adherence to Clinical Trial requirements

Working conditions

• Work which is constantly and exceptionally tiring mentally and/or visually. Conditions exist more than 90% of the work time
• Involves considerable standing or walking, regular lifting of light-weight objects (i.e., 20 pounds or less) and assisting with heavier tasks such as assisting in lifting and moving patients
• Minor straining or fatiguing positions must be assumed, and some fatiguing physical motions are required

Schedule

Full time, 40 hours per week, first shift.