Senior Research Coordinator - Clinical Trials Unit

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

The Senior Research Coordinator in the Clinical Trials Unit will be primarily responsible for complex project management for multiple research studies related to psychiatric conditions in pediatric patients. Activities include but are not limited to project execution, implementation, daily administration and close out for multiple research studies. The Senior Research Coordinator will ensure precise implementation of and adherence to study protocol, create all study documentation, oversee operating procedures, timelines, IRB applications, data preparation, and other research-related activities. In addition to operational management of multiple research studies, the Senior Research Coordinator will see patients participating in ongoing clinical trials, and will be responsible for specimen collection, processing, and DOT/ IATA compliant handling and shipment.

• Prepare and submit Institutional Review Board (IRB) required materials, as well as prepare compliance and regulatory documentation for local, state, and federal agencies and any other pertinent entity.
• Manage ongoing IRB activities including preparation and submission of initial applications, changes in research, protocol deviations, annual continuing reviews, and termination reports.
• Create and maintain multiple IRB accounts and investigator notebooks and report adverse events.
• Implement and ensure adherence to protocol for multiple studies simultaneously.
• Respond to questions regarding protocol content from site staff.
• Continuously educate and train personnel, patients, and caregivers on protocol compliance.
• Identify protocol problems, inform investigators, and assist in problem resolution efforts.
• Develop protocol compliant site-specific study documentation for multiple studies. Responsible for developing and producing custom and routine reports as necessary.
• Conduct ongoing clinical trial and research study activities with minimal direction. Such activities include (1) participant recruitment and scheduling, (2) study procedure scheduling and coordination, (3) conducting patient visits and executing study procedures, (4) managing specimen collection and processing, (5) obtaining results and ensuring clinician review, (6) documentation completion, and (7) 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.
• Responsible for independent project management of multiple research studies and regular communication with research collaborators, study sponsor, and study vendors.
• Manage research data in accordance with protocols established by sponsors and the Institute. Lead efforts on data preparation, data entry, transfer, archiving, maintenance, and analysis as needed. Provide and communicate data-related study matters to research collaborators.
• Oversee deliverables for monitoring requirements, site initiation visits, review and approval of monitoring plan; ensure monitoring is conducted in accordance with Standard Operating Procedures (SOPs) and monitoring plan; ensure timeliness of monitoring and follow-up action items are completed.
• Responsible for resolving all study-related queries, final study closeout, and lock of databases.
• Attend study and research-related meetings, conferences, and teleconferences.
• Develop and maintain SOPs, for the program and the Institute, that adhere to and promote to the tenets of Good Clinical Practice.
• Participate in research planning, development, and legacy activities.
• Assist with general administrative work, including processing subject reimbursements and incentives, inventory and ordering supplies, and organizing service billing.

EDUCATION

• Bachelor’s degree is required, preferably in psychology, statistics, or neurosciences.
• Master’s degree preferred.

EXPERIENCE

Requires at least four (4) years of research related work experience.

USD $50,786.11/Yr.

USD $87,503.31/Yr.