Senior Research Coordinator - Clinical Trials Unit

Kennedy Krieger Institute•Baltimore, MD

About The Position

The Senior Research Coordinator will be primarily responsible for complex project management for multiple research studies related to neurological, neurogenetic, neurodevelopmental, and psychiatric conditions in children, adolescents, and adults. This includes, but is not limited to, project execution, implementation, daily administration and close out for multiple research studies. The incumbent will ensure precise implementation of and adherence to study protocol; create all study documentation; and oversee operating procedures, timelines, IRB applications, and data preparation. In addition to operational management of multiple research studies, this position will see patients participating in ongoing clinical trials, and will be responsible for specimen collection, processing, and Department of Transportation (DOT)/International Air Transport Association (IATA) compliant handling and shipment.

Requirements

Bachelor’s degree is required, preferably in psychology, mathematics/statistics, neuroscience, biology, biophysics, physics, chemistry, biochemistry, or another related field.
Minimum four (4) years of research related work experience required, to include direct clinical trial experience involving investigational product.

Nice To Haves

Master’s degree preferred.

Responsibilities

Prepare and submit Institutional Review Board (IRB) required materials, and 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 protocols 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. Develop and produce custom and routine reports as necessary.
Conduct ongoing clinical trial and research study activities with minimal direction. This includes participant recruitment and scheduling, study procedure scheduling and coordination, conducting participant visits and executing study procedures, managing specimen collection and processing, obtaining results and ensuring clinician review, documentation completion, and reporting.
Administer blood draws via venipuncture, electrocardiograms (ECGs), and collect vital signs for participants.
Process and ship collected biomaterials in accordance with DOT and IATA hazmat regulations.
Provide independent project management of multiple research studies and regularly communicate 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, and ensure timeliness of monitoring and follow-up action item completion.
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 participant reimbursements and incentives, inventory and ordering supplies, and organizing service billing.