Clinical Research Coordinator - Full time, 40 hours per week - Pediatric Hematology/Oncology - Kalamazoo, MI
Bronson Healthcare•Kalamazoo, MI
•Onsite
About The Position
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.
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.
- 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
Nice To Haves
- Professional certification (SOCRA or ACRP) preferred within 4 years of date of hire.
- IATA Certification for shipping infectious substances and diagnostic specimens
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
