Senior Research Coordinator - Clinical Trials Unit at Kennedy Krieger Institute

Baltimore, Maryland, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Jun, 26

Salary

87503.31

Posted On

07 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Clinical Trials, Protocol Implementation, IRB Applications, Regulatory Documentation, Specimen Collection, DOT Compliance, IATA Compliance, Data Management, Venipuncture, Electrocardiograms, Personnel Training, SOP Development, Data Analysis, Monitoring Oversight, Study Closeout

Industry

Hospitals and Health Care

Description

Overview 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. Responsibilities 1. 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.2. 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.3. Develop protocol compliant site-specific study documentation for multiple studies. Develop and produce custom and routine reports as necessary.4. 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.5. Administer blood draws via venipuncture, electrocardiograms (ECGs), and collect vital signs for participants. 6. Process and ship collected biomaterials in accordance with DOT and IATA hazmat regulations.7. Provide independent project management of multiple research studies and regularly communicate with research collaborators, study sponsor, and study vendors.8. 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.9. 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.10. Responsible for resolving all study-related queries, final study closeout, and lock of databases.11. Attend study and research-related meetings, conferences, and teleconferences. 12. Develop and maintain SOPs for the program and the Institute that adhere to and promote to the tenets of Good Clinical Practice.13. Participate in research planning, development, and legacy activities.14. Assist with general administrative work, including processing participant reimbursements and incentives, inventory and ordering supplies, and organizing service billing. Qualifications EDUCATION:• Bachelor’s degree is required, preferably in psychology, mathematics/statistics, neuroscience, biology, biophysics, physics, chemistry, biochemistry, or another related field. • Master’s degree preferred. EXPERIENCE:Minimum four (4) years of research related work experience required, to include direct clinical trial experience involving investigational product. Minimum pay range USD $50,786.11/Yr. Maximum pay range USD $87,503.31/Yr.

Responsibilities

The Senior Research Coordinator manages complex project execution, implementation, and daily administration for multiple neurological and psychiatric research studies, ensuring strict adherence to study protocols. This role also involves direct patient interaction, including conducting clinical trial procedures, collecting specimens, and managing regulatory documentation.