Clinical Research Coordinator

Work Location IC: NINDS Street: 10 Center Dr Bldg: 10 Room: 2B51B City : Bethesda State & Zip : MD 20814 Work Hours Weekly Hours FT: 30-40 hours per week # Of Hours 40 Position Requirements Overall Position Summary and Objectives The primary role for this Research Coordinator (RC) position is to provide clinical research coordination through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific groups as assigned. Minimum Education Bachelor's Resume Max Pages 3 Additional Qualifications Certifications & Licenses Clinical Research Associate (CRA) Field of Study Miscellaneous Health Medical Professions - Nursing - Community and Public Health - General Medical and Health Services - Neuroscience Miscellaneous Biology - Cognitive Science and Biopsychology - Biology Genetics - Health and Medical Preparatory Programs - Nutrition Sciences - Pharmacy Pharmaceutical Sciences and Administration Treatment Therapy Professions - Communication Disorders Sciences and Services - Sociology - Miscellaneous Social Sciences - Interdisciplinary Social Sciences - General Social Sciences - Miscellaneous Psychology - Clinical Psychology - Psychology - Social Psychology - Social Work Chemistry - Multi-Disciplinary or General Science Software Clinical Trial Management System (CTMS) Electronic Medical Records System Electronic Data Capture System Skills Overseeing and documenting IP dispensing, inventory and reconciliation Closing clinical trial sites down on completion of clinical trial Ordering, tracking, and managing IP and trial materials Implementation of clinical trial site action plans Training clinical trial site staff Coordinating project meetings Previous clinical trial work Electronic medical records Protocol review revision Phase I or II experience Patient confidentiality Remote site monitoring Regulatory compliance Protocol development Good Clinical Practice (GCP) knowledge Protocol writing Clinical Trials Data Monitoring Data Integrity Patient care Recruitment Scheduling Screening Research ICH/GCP SOPs Statement of Work Details Supports clinical staff develop, implement and maintain clinical research data files and materials. 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 required 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 Maintains all professional licenses and 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 Collects research data and prepares information for inputs and analysis. Verify study participant information and collect data and results of testing Assist staff develop, assemble related documentation and maintain regulatory binders for all protocols 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 Supports the development of forms and questionnaires. 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 Review draft protocols, case report forms, and manuals of operations for clarity, and completeness 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 Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests. 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 e.g. private industry, Federal agency, investigator Monitors subject's progress and reports adverse events. 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 e.g., literacy, capacity, language, distress, lack of time, therapeutic misconception Obtain or confirm informed consent assent completion prior to the beginning of any studies or therapies Supports assembly, development and review of new research projects. 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 key research personnel ensure that clinical research activities are performed in accordance with federal, state and institutional regulations, policies and procedures 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, and data quality Provides a redacted copy of the informed consent form for regulatory submission at time of continuing review Supports the creation and management of clinical websites and web-based tools. Maintain content on the Clinical Studies websites resources for staff and extramural investigators Collaborate with information technology IT staff to perform updates to a variety of websites Create mock ups and visualizations to illustrate to web developers how to execute web enhancements or new web requirements - Work with investigators to Assist researchers submit protocol packages, actions and applications to IRB using the designated protocol tracking and management databases system Organizes and performs clinical research, utilizing internet and other available clinical resources. Monitor electronic medical record system to ensure necessary components are present and complete such as data collection forms, progress notes, participant information forms and diagnostic test completion forms Coordinate with relevant parties regarding data sharing plan review and tracking of data submission per approved plans Update annual status of recruitment enrolment in NIH Human Subjects Reporting System Provides assistance to staff in the collection, development and quality control of essential clinical research efforts. 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 Schedule and participate in monitoring and auditing activities and coordinate responses to audits Assist staff on all facets of clinical studies including subject enrolment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample collection and data entry Assess protocols and studies for regulatory compliance, adherence to IRB approvals and Federal standards, such as HIPAA, human subject ethics, privacy, etc and generate quality assurance reports Assist researchers coordinate, facilitate and prepare site for monitoring visits and FDA audits Creates and updates protocol operating policies and procedures e.g. MOPs as needed Identifies and develops relationships with institutional or community-based resources or groups that can assist in achieving recruitment goals Participates in developing recruitment materials with input of PIs and IRB approval for referral sources outlining eligibility information Performs and/or coordinates outreach activities, as appropriate to meet research recruitment and enrolment goals Serves as a communication liaison between interdisciplinary team and the research participant Documents, collects, records, and retains all research related participant encounters including in person, phone, or electronic in the research record e.g. source documents, case report forms according to regulations, guidelines, and institutional specific policies, including ensuring good documentation practices for all documents Maintains the privacy and confidentiality of participant and research data; Protects participant, protocol, and scientific confidentiality by ensuring security of research data and personal health information Anticipates and consistently meets reporting deadlines, collaborating with PIs and teams to note data trends and identify problems Notes trends in toxicities, participant information and data collection points Supports clinical staff develop, implement and maintain clinical research data files and materials. 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 required fields Assist researchers with study testing, observations data entry and other duties associated with study sessions Collaborates with principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugs, biologics, and devices Develops and facilitates training to new research coordinators and mentors researchers in Good Clinical Practices. Instruct data entry and clinical staff in procedures relative to data management, protocol instructions, Standard Operating Procedures and regulatory processes and considerations Organize, prepare and distribute informational materials and provide support to the educational mission of the study Researches changes and updates to Good Clinical Practices GCP and prepares summaries, job aids and training materials for research staff and new clinical research coordinators Prepare materials, coordinate scheduling, track attendance and report results of workshops related research best practices, emerging trends in clinical studies, new literature and findings and regulatory considerations Mentor new clinical research coordinators on all aspects of research support Performs problems-solving and improves processes as needed to resolve complex and/or unpredictable situations Manages conflicts issues that arise in clinical research setting, by utilizing strong communication and collaboration skills #J-18808-Ljbffr