Clinical Protocol Coordinator

Position Objective: Provide services as a Clinical Protocol Coordinator in support of the overall functions of the Division of Intramural Research Stroke Branch Stroke Diagnostics and Therapeutics Section at the National Institute of Neurological Disorders and Stroke (NINDS).

Duties and Responsibilities:

• Assist with the planning and execution of the most appropriate approaches to attain the laboratorys research goals.
• Develop or improve systems of data collection verification and management.
• Evaluate and recommend new types of research approaches and recommend changes to processes/protocols based on review and knowledge of the research priorities.
• Measure project performance to identify areas for improvement.
• Support the revision and development of human subjects protocols as needed and assist with the coordination of activities and approvals.
• Perform data collection validation and analysis including regular internal audits of collected data at the research sites.
• Recommend and assist with the implementation of improvements to work-flow and operational procedures to increase efficiency productivity and make overall improvements for research activities.
• Coordinate with PI and Senior Protocol Advisor to help coordinate research staff at multiple sits where research is conducted to assist with the planning implementation and monitoring of the clinical research protocols. Provide weekly to monthly progress reports

on research projects. 3

• Initiate and track research agreements and material transfer agreements (MTA) with all projects and researchers to define rights of the provider and recipient in respect to data and its derivatives.
• Work with staff on the training of personnel research assistants post-doctoral fellows students visiting scientists and others in specialized technologies.
• Collaborate with staff on the preparation of internal research proposals abstract submissions poster presentations and manuscript drafts.
• Assists researchers with protocol development assembly and review of clinical trial documents.
• Assist researchers develop prepare internal research proposals abstract submissions poster presentations and manuscript drafts. 1
• Assist researchers develop protocol documentation including schemas patient calendars and teaching aids. 2
• Assist researchers develop clinical research informed consent and other ethics and regulatory related documentation. 3
• Assist researchers develop standard operating procedures (SOPs) for the clinical study.
• Assist researchers prepare study reports and status updates including amendments audits and other administrative documentation.
• Assists researchers develop and maintain trial related documents and operational procedures.
• Assist researchers collect organize and maintain all study documentation to include investigator qualifications trial logs and safety reports.
• Assist researchers maintain accurate records of all protocols and study applications safety reports annual reports and correspondence. 4
• Assist researchers write and edit study protocols and prepare amendments reviews reports and other necessary forms. 5
• Assist researchers prepare and submit study safety reports and other regulatory correspondences including initial submissions information requests amendments and annual reports.
• Assist researchers track and review adverse event files and report events in accordance with Institutional Review Board (IRB) processes and policies.
• Maintains study databases and conducts basic analysis.
• Maintain data files within multiple software systems including computerized procurement reports and communication programs.
• Perform entry and cleanup of study of the questionnaire data in various databases and conduct queries to answer researcher questions.
• Assist researchers track study requests and protocol approvals maintaining a record of all submissions and status of approvals.
• Assist researchers prepare review and submit clinical data to monitoring agencies.
• Assists researchers collect distribute and file regulatory documents.
• Assist researchers prepare and communicate with IRB and NIH Clinical Center for protocol approval.
• Assist researchers prepare submissions to regulatory bodies in support of clinical trials.
• Provides technical support to researchers and the clinic.
• Assist staff on protocol coordination including matching and locating control subjects completing registration phone calls reviewing study questionnaires and resolving queries with patients.
• Assist researchers coordinate recruitment scheduling travel and admission of research study participants with clinical staff.
• Assist researchers screen study participants and document results of screenings.
• Liaison between study participants participants relatives and staff members and communicate participants questions complaints problems and concerns to appropriate staff members.

Basic Qualifications:

• Masters Degree in General Medical and Health Services related fields.
• Minimum of one (1) years of experience in clinical research coordination or related field.
• Familiarity with IRB requirements.
• Experience with Clinical Trial Management System (CTMS) Microsoft Office Products and Electronic Data Capture System.
• Experience in clinical data management databases operations and analysis - Liaising with regulatory authorities - Previous clinical trial work - Regulatory compliance - Protocol development - Clinical Research - Clinical Trials - Data Monitoring - SOPs

Minimum Qualifications:

• Ability to multi-task and pay close attention to detail.
• Excellent analytical and interpersonal organizational and time management skills.

*This job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required by this position.

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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Qualified applicants will receive consideration for employment without regard to race color religion sex national origin disability protected veteran status or other characteristics protected by law.

This position is contingent upon contract award