Senior Research Coordinator - Clinical Trials Unit

About the role

The Senior Research Coordinator in the Clinical Trials Unit will manage complex projects for multiple research studies focused on psychiatric conditions in pediatric patients. This role involves project execution, implementation, daily administration, and close-out of studies while ensuring adherence to protocols and regulatory requirements.

Responsibilities

• Oversee the operational management of multiple research studies, including protocol implementation and adherence.
• Create and maintain study documentation, operating procedures, timelines, and IRB applications.
• Prepare and submit compliance and regulatory documentation for local, state, federal agencies, and other entities.
• Manage ongoing IRB activities, including initial applications, changes in research, protocol deviations, annual continuing reviews, and termination reports.
• Create and maintain multiple IRB accounts and investigator notebooks; report adverse events.
• Ensure adherence to protocols for multiple studies simultaneously and respond to protocol-related questions from site staff.
• Educate and train personnel, patients, and caregivers on protocol compliance.
• Identify protocol problems, inform investigators, and assist in problem resolution.
• Develop protocol-compliant, site-specific study documentation for multiple studies.
• Develop and produce custom and routine reports as necessary.
• Conduct clinical trial and research study activities with minimal direction, including:
  • Participant recruitment and scheduling.
  • Study procedure scheduling and coordination.
  • Conducting patient visits and executing study procedures.
  • Managing specimen collection and processing.
  • Obtaining results and ensuring clinician review.
  • Completing documentation and reporting.
• Administer blood draws via venipuncture, ECGs, and collect vital signs for pediatric patients.
• Process and ship collected biomaterials in accordance with DOT and IATA hazmat regulations.
• Manage research data in accordance with sponsor and Institute protocols, including data preparation, entry, transfer, archiving, maintenance, and analysis.
• Communicate data-related study matters to research collaborators.
• Oversee deliverables for monitoring requirements, site initiation visits, and monitoring plans; ensure compliance with SOPs and timeliness of monitoring activities.
• Resolve study-related queries, finalize study closeout, and lock databases.
• Attend study and research-related meetings, conferences, and teleconferences.
• Develop and maintain SOPs that adhere to Good Clinical Practice.
• Participate in research planning, development, and legacy activities.
• Assist with general administrative tasks, including processing subject reimbursements, inventory and supply ordering, and organizing service billing.

Requirements

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

Pay

USD $50,786.11 – $87,503.31 per year.