Clinical Research Coordinator

Position Objective: Provide services as a Clinical Research Coordinator in support of the overall functions of the National Institute of Neurological Disorders and Stroke (NINDS) within the National Institutes of Health (NIH). The primary role for this Research Coordinator (RC) position is to provide clinical research coordination and protocol navigation for the NINDS Intramural Research Program.

Duties and Responsibilities:

• Assist preparing and submitting for review accurate source documents related to all research procedures.
• 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 re-quired fields.
• Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB). 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. 5
• Maintains all professional certifications, if applicable.
• Maintain a current clinical trial and clinical research study Good Clinical Practice GCP knowledge base, in order to serve as an expert resource to the client in a regularly changing field, and addresses identified knowledge and skill gaps related to role.
• 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.
• 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.
• Enter data into research databases, systems and applications for ongoing studies. 4
• Verify study participants information and collect data and results of testing, including verification data for eligibility criteria.
• Assist researchers in collecting, organizing, and maintaining accurate records of all protocols and study applications, investigator qualifications, study logs, safety reports, annual reports, and correspondence.
• Monitor research team training requirements, including maintaining all training records and providing notifications for training renewal deadlines.
• Assist researchers develop, maintain and complete study data collection forms and source documents.
• Assist staff writing and editing clinical research protocols and informed consent forms (ICFs) based upon templates. Work with staff on the design, development and preparation of documents such as spreadsheets, letters, rosters,
• agendas, presentations and meeting minutes/summaries.
• Assist researchers design patient Case Report Forms (CRFs).
• Review draft protocols, case report forms, and manuals of operations (MOPs) for clarity, and completeness, as well as provide input to modify them as needed.
• Retrieve research related information from medical records, hospital information system and laboratory information system and create spreadsheets and other reports for use in study analysis.
• Prepare patient charts for clinic days and provide initial or follow-up assessment forms, patient labels, most recent medication lists and lab and procedure printouts.
• Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures.
• Schedule and coordinate outpatient and inpatient visits, diagnostic studies and medical tests. Assist researchers with the collection and analysis of research data and samples.
• Adheres to applicable Federal, State, and NINDS regulations, policies, and procedures related to clinical research including biospecimen handling shipment.
• Complies with processes and procedures required by different types of sponsors and contractual partners eg private industry, federal agency, and investigator.
• Process, maintain and generate reports from research study data and metadata as needed to assist with study monitoring and data sharing requirements, and recommend preemptive actions as needed.
• Liaison between the study subjects and the investigators concerning any problems or adverse events including out of range vitals, etc.
• Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events. Update and maintain logs and records of patient and family contacts.
• Provide continuity of care to patients enrolled on assigned protocols.
• Assesses participants understanding of the information provided during the informed consent process. Assesses ongoing consent through discussions with participants and reinforcement of education.
• Identifies and intervenes to address facilitators and barriers to effective informed consent discussions and decision making eg, literacy, capacity, language, distress, lack of time, therapeutic misconception.
• Obtain or confirm informed consent and or assent completion prior to the beginning of any studies or therapies.
• Assist researchers in tracking and reviewing adverse event files in accordance with Institutional Review Board IRB processes and policies.
• Assist protocol staff submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• Assist researchers obtain IRB approval before any study related activities begin.
• Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures.
• Contributes to discussions regarding feasibility of protocol implementation and execution with a specific focus on clinical issues, available resources, study coordination, participant safety, data quality, and recommend operational improvements..
• Provides a redacted copy of the informed consent form for regulatory submission at time of continuing review.
• Assist key research personnel in ensuring that clinical research activities are performed in accordance with all federal, state, and NINDS regulations, policies and procedures related to human subjects’ research.
• Assist researchers with developing protocol documentation including schemas, informed consent and assent documents, other regulatory documents.
• Assist researchers in obtaining NINDS approval before any study related activities begin.
• Assist researchers in communicating with IRB, NIH Clinical Center, and other regulatory authorities for protocol approval.
• 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. 1
• Prepare and submit for review accurate source documents related to all research procedures. 2
• 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. 3

Basic Qualifications:

• Bachelor’s degree in nursing, community and public health, biology, social work, social psychology, or a related discipline.
• Association of Clinical Research Professionals Certified Professional (ACRP-CP).
• Association of Clinical Research Professionals (ACRP).
• Certified Clinical Research Professional (CCRP).
• Certified Clinical Research Coordinator (CCRC).
• Certified Clinical Research Associate (CCRA).
• Experienced working with Clinical Trial Management System (CTMS), Electronic Medical Records System, and Electronic Data Capture System.
• Demonstrated experience overseeing and documenting IP dispensing, inventory, and reconciliation.
• Experienced closing clinical trial sites down on completion of clinical trial.
• Experience with ordering, tracking, and managing IP and trial materials.
• Experience with the implementation of clinical trial site action plans and training clinical trial site staff.
• Experienced in coordinating project meetings, electronic medical records, protocol review revision, patient confidentiality, remote site monitoring, regulatory compliance, protocol development, clinical research, clinical trials, and protocol writing.
• Experienced in data monitoring, data integrity, patient care, recruitment, scheduling, screening, research, ICH/GCP, and SOPs.
• Experience liaising with regulatory authorities and liaising with ethics committee.
• Experienced with protocol navigation, regulatory affairs, and IRB submissions.
• Previous clinical trials and Phase I or II work experience required.