Clinical Research Coordinator Pediatrics

Department:

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Position Title:

Job Family Group:

Job Description Summary:

Job Description:

Job Duties Outlined:

Study Conduct/Clinical Research Practice:

• Coordinate study activities including preparing personnel protocols informed consents amendments and IRB/Sponsor documents.
• Prepare electronic data collection tools assemble study visit supplies and assist with study implementation.
• Collect label and process samples per protocol ensuring proper handling storage and compliance with study leadership guidance.
• Maintain inventory of supplies and equipment operate standard lab and study equipment and track study expenditures.
• Identify and address data collection issues ensure audit readiness.

Regulatory Compliance and Documentation:

• Complete required regulatory activities and maintain accurate records.
• Assist with protocol preparation IRB submissions and regulatory correspondence.
• Ensure compliance with federal/state regulations GCP and institutional policies ensuring compliance across all activities.
• Recognize and report adverse events/serious adverse events per protocol requirements.

Recruitment/Enrollment/Retention:

• Identify approach and enroll eligible participants according to protocol.
• Conduct informed consent in-person by phone or via telehealth.
• Coordinate study visits provide participant instructions and reimbursement and maintain participant status in systems.
• Communicate with participants clinical teams and report recruitment/retention challenges or recommendations for improvements.

Communication:

• Assist in organizing study correspondence and direct inquiries to appropriate team members.
• Build and maintain professional relationships with participants families providers and staff.
• Contribute to departmental research discussions and recommend improvements to study conduct.

Data Management:

• Complete Case Report Forms (CRFs) and source documentation in line with GCP and study protocols.
• Review CRFs for accuracy completeness and compliance entering data into auditable databases or electronic systems.
• Maintain participant tracking and data collection systems performing quality checks and resolving missing data per protocol.

This job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job not an exhaustive list of all possible job responsibilities tasks duties and assignments. Furthermore job duties responsibilities and activities may change at any time with or without notice.

Required Qualifications

Work Experience:

• Four years of relevant experience. Education may be substituted for experience on a year for year basis.
• Experience with regulations governing clinical research (CFR GCP HIPAA).
• Experience with statutes and guidelines relevant to regulatory affairs in clinical research.
• Experience with study budgets contracts and grant applications.
• Experience working with children parents and/or families.

Preferred Qualifications

Education:

• Bachelors degree in relevant field.

Certifications/Licenses:

• One or more of the following:
  • Certified Clinical Research Coordinator (CCRC)
  • Certified Clinical Research Professional (CCRP)

Work Experience:

• Experience with common clinical research software (e.g. REDCap SPSS STATA) and electronic health record systems.

Skills

• Communication
• Organization
• Presentation skills
• Attention to detail
• Interpersonal skills
• Time management
• Multitasking
• Problem solving

Required Documents

• Resume/CV
• Cover Letter

Comprehensive Benefits Package: