Pediatric Clinical Trials Lead & Research Operations

Kennedy Krieger Institute; Baltimore (MD); On-site; USD 51,000 - 88,000; Full time

Job summary

Kennedy Krieger Institute is seeking a Senior Research Coordinator for the Clinical Trials Unit to lead complex project management across multiple pediatric psychiatry studies. This role involves protocol adherence, IRB submissions, data handling, and coordination of visits, specimen handling, and regulatory tasks.

Responsibilities include IRB administration, staff training, protocol problem resolution, and production of reports.

Qualifications

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

Responsibilities

• Prepare and submit IRB materials and regulatory documentation.
• Manage IRB activities including initial applications, changes, and continuing reviews.
• Create and maintain IRB accounts and investigator notebooks; report adverse events.
• Implement and ensure adherence to protocol for multiple studies.
• Respond to protocol questions from site staff.
• Educate and train personnel, patients, and caregivers on protocol compliance.
• Identify protocol problems and assist in resolution.
• Develop protocol-compliant documentation and routine reports.
• Conduct study activities: recruitment, scheduling, visits, and data handling.
• Administer blood draws and handle specimens per DOT/IATA regulations.
• Lead project management across multiple studies; communicate with sponsors and vendors.
• Oversee monitoring deliverables and ensure SOP compliance.
• Resolve study queries and finalize databases.
• Attend study meetings and planning sessions.
• Develop SOPs aligning with Good Clinical Practice.
• Assist with administrative tasks like reimbursements and inventory.

Education

Bachelor’s degree

Master’s degree

Job description

Kennedy Krieger Institute is seeking a Senior Research Coordinator for the Clinical Trials Unit to lead complex project management across multiple pediatric psychiatry studies. This role involves protocol adherence, IRB submissions, data handling, and coordination of visits, specimen handling, and regulatory tasks.

Responsibilities include IRB administration, staff training, protocol problem resolution, and production of reports.