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

Location: Bronson Methodist Hospital, Kalamazoo, MI – Pediatric Hematology/Oncology – On site, full time, 40 hours per week.

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 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 documentation.
• 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 Principal Investigator (PI) to prepare 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 audits with the Central COG office and maintain readiness for those audits.
• Other duties as assigned.

Requirements

• Bachelor’s degree in scientific, healthcare, or equivalent field, or equivalent experience in data entry, research, or healthcare administration.
• Education in the protection of human research participants and Good Clinical Practices.
• 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.

Skills

• 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 is constantly and exceptionally tiring mentally and/or visually, with conditions existing 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 lifting and moving patients.
• Minor straining or fatiguing positions must be assumed, and some fatiguing physical motions are required.

Schedule

First shift, full time, 40 scheduled weekly hours.