The National Institutes of Health is seeking a Senior Clinical Research Coordinator . This is a long-term, full-time, contract position based in Bethesda, MD. This position offers a competitive benefits package.

PRIMARY RESPONSIBILITIES:

• Participate in coordination and management of most daily activities of the study and ensure that study activities follow established protocol, Standard Operating Procedures (SOP), and utilizes approved forms, templates and practices.
• Prepare and submit for review accurate source documents related to all research procedures.
• Prepare and submit Case Report Forms (CRFs) and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other re-quired fields
• Assists clinical and research staff ensure that Case Report Forms (CRFs) are completed and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other required fields.
• Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB).
• Enter data into research databases, systems and applications for ongoing studies.
• Participate in developing and maintaining research protocol documentation and operations.
• Assist researchers with study testing, observations data entry and other duties associated with study sessions
• Attend in-person meetings located at the NIH campus in Bethesda or virtual meetings, including protocol development meetings, research coordinator forum meetings, as well as regular research team meetings.
• Show initiative and strong independent problem-solving skills in making recommendations for improving research team processes in general, and as needed to efficiently resolve complex or unpredictable situations.
• Identify inefficiencies and recommend changes to research protocol documentation procedures that can improve study productivity. Independently and effectively troubleshoot issues that arise in clinical research setting, by utilizing strong communication and collaboration skills.
• Maintain a line of communication with the Institutional Review Board IRB to keep abreast of new guidance related to protocol and informed consent submissions for initial reviews and amendments.
• Collects research data and prepares information for inputs and analysis. Perform accurate and timely data analysis, report results and findings and respond to sponsor queries.
• Set up, format and enter data into spreadsheets to analyze information and create reports.

REQUIREMENTS:

• Master’s degree is Biology, Psychology, or related discipline
• Minimum 5 years of experience with investigational new drug (IND) studies
• Minimum 5 years as a clinical research coordinator