Senior Research Coordinator - Clinical Trials Unit

Kennedy Krieger Institute, Inc.

Baltimore, Northern (MD, KY)

Hybrid

USD 51,000 - 88,000

Full time

9 days ago

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Job summary

Kennedy Krieger Institute, Inc. in Baltimore, MD, is seeking a Senior Research Coordinator for the Clinical Trials Unit to oversee complex pediatric psychiatric studies and ensure strict protocol adherence.

You will manage IRB submissions, documentation, data preparation, and regulatory reporting, while coordinating patient visits, specimen handling, and study procedures. Requires a Bachelor’s degree (Master’s preferred) and at least four years of relevant research experience; this is a regular

Qualifications

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

Responsibilities

Prepare and submit IRB materials and regulatory documentation for local, state, and federal agencies.
Manage ongoing IRB activities including initial applications, protocol deviations, annual reviews, and termination reports.
Create and maintain IRB accounts and investigator notebooks and report adverse events.
Implement and ensure protocol adherence for multiple studies simultaneously.
Respond to protocol questions from site staff.
Educate and train personnel, patients, and caregivers on protocol compliance.
Identify protocol problems and assist in problem resolution.
Develop protocol compliant site-specific study documentation and generate reports.
Conduct study activities including recruitment, scheduling, visits, procedures, and data handling.
Administer blood draws via venipuncture, ECGs, and process biomaterials per DOT/IATA rules.
Manage data preparation, entry, transfer, and archiving; communicate data-related issues to collaborators.
Oversee monitoring deliverables and ensure SOP compliance and timely actions.
Resolve all study queries and perform final closeout and database lock.
Attend study meetings and conferences; assist with planning and legacy activities.
Assist with administrative work including reimbursements, inventory, and billing.

Education

Bachelor’s degree

Master’s degree preferred

Job description

Overview

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.

Responsibilities

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.