CHEManager International · 5 hours ago
Clinical Research Assistant - Part time, 24 hours per week - Pediatric Hematology/Oncology office -
Kalamazoo, MI
Part-time
Onsite
New Grad, Entry LevelCHEManager International is seeking a Clinical Research Assistant to join their Pediatric Hematology/Oncology office. The role involves reviewing and updating consent documents, preparing study activity documents for IRB meetings, and organizing study files for regulatory audits.
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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
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
Qualification
Required
Associate's degree
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
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
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
Preferred
Bachelor's degree
Prior research experience
Education in the protection of human research participants and Good Clinical Practices
Company
CHEManager International
Wiley’s leading media brand providing first-hand information on the global chemical, life science and process industries
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase