Senior Pediatric Clinical Trials Lead

Kennedy Krieger Institute, Inc.; Baltimore, Northern (MD, KY); Hybrid; USD 51,000 - 88,000; Full time

Job summary

Kennedy Krieger Institute, Inc. in Baltimore, MD, is seeking a Senior Research Coordinator for the Clinical Trials Unit to oversee complex pediatric psychiatric studies and ensure strict protocol adherence.

You will manage IRB submissions, documentation, data preparation, and regulatory reporting, while coordinating patient visits, specimen handling, and study procedures. Requires a Bachelor’s degree (Master’s preferred) and at least four years of relevant research experience; this is a regular

Qualifications

• Requires at least four (4) years of research related work experience.
• Bachelor’s degree required, preferably in psychology, statistics, or neurosciences.
• Master’s degree preferred.

Responsibilities

• Prepare and submit IRB materials and regulatory documentation for local, state, and federal agencies.
• Manage ongoing IRB activities including initial applications, protocol deviations, annual reviews, and termination reports.
• Create and maintain IRB accounts and investigator notebooks and report adverse events.
• Implement and ensure protocol adherence for multiple studies simultaneously.
• Respond to protocol questions from site staff.
• Educate and train personnel, patients, and caregivers on protocol compliance.
• Identify protocol problems and assist in problem resolution.
• Develop protocol compliant site-specific study documentation and generate reports.
• Conduct study activities including recruitment, scheduling, visits, procedures, and data handling.
• Administer blood draws via venipuncture, ECGs, and process biomaterials per DOT/IATA rules.
• Manage data preparation, entry, transfer, and archiving; communicate data-related issues to collaborators.
• Oversee monitoring deliverables and ensure SOP compliance and timely actions.
• Resolve all study queries and perform final closeout and database lock.
• Attend study meetings and conferences; assist with planning and legacy activities.
• Assist with administrative work including reimbursements, inventory, and billing.

Education

Bachelor’s degree

Master’s degree preferred

Job description

Kennedy Krieger Institute, Inc. in Baltimore, MD, is seeking a Senior Research Coordinator for the Clinical Trials Unit to oversee complex pediatric psychiatric studies and ensure strict protocol adherence.

You will manage IRB submissions, documentation, data preparation, and regulatory reporting, while coordinating patient visits, specimen handling, and study procedures. Requires a Bachelor’s degree (Master’s preferred) and at least four years of relevant research experience; this is a regular