Clinical Research Assistant - Part time Pediatric Hematology​/Oncology offi

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BMH Bronson Methodist Hospital

Clinical Research Assistant - Part time, 24 hours per week - Pediatric Hematology/Oncology office - Kalamazoo, MI

Under general supervision the Clinical Research Assistant is responsible for reviewing, editing, and updating the Children’s Oncology Group (COG) consent documents initiated by new study activations, amendments and annual reviews. The Research Assistant prepares documents of all study activity for Institutional Review Board (IRB) meetings, as well as, regularly organizes and updates hard files for office use and regulatory audits.

Associate's degree required, Bachelor's preferred. Prior research experience preferred. Education in the protection of human research participants and Good Clinical Practices preferred. IATA Certification for shipping infectious substances and diagnostic specimens.

• Ability to learn complex concepts (regulatory, ethical, and scientific)
• Excellent Microsoft Office and internet usability
• Superior word processing, proof-reading, and editorial skills with regard to scientific documents
• Ability to read and interpret research and clinical trial documents and instructions
• Self-directed and detail-oriented with strong analytical and problem-solving skills
• Advanced written and verbal communication skills
• Excellent interpersonal skills and the ability to work constructively with physicians and other related departments (pathology), and Bronson employees
• Ability to work effectively and efficiently under tight deadlines, high volumes, and multiple interruptions with precision and adherence to clinical trial requirements

Works in a clean, well lit, and temperature controlled smoke-free environment. Must be able to sit or stand at work station for up to two to three hours at a time, ability to hear within normal range and have the physical capability and hand dexterity to operate switchboard equipment and basic office equipment. Must be able to lift, carry, pull or push up to 25 pounds.

Must have excellent verbal and written communication skills. Ability to maintain positive customer service. Ability to establish effective working relations with office staff and employees in a team environment. Must maintain the highest level of confidentiality. Effective prioritization skills and ability to manage time independently.

• 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
• Other duties as assigned, may include, but are not limited to:
• Coordinate comprehensive clinics for Hemophilia, Sickle Cell, and Hem/Onc patients
• Coordinate health management visits for patients with Children Special Healthcare
• Prep charts for comprehensive and management visits.

I. DOCUMENTATION:
Demonstrates the competencies associated with the paperwork or charting aspect of the job...

II. JUDGMENT/DECISION MAKING:
Demonstrates the ability to evaluate the factors relevant to a situation and make timely decisions that add value to the services provided...

III. TECHNICAL

SKILLS:

Demonstrates competency in the skills…