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 through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific groups as assigned.

Duties and Responsibilities:

• Assist preparing and submitting for review accurate source documents related to all research procedures. 2
• 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
• 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.
• Ensure Case Report Forms (CRFs) are complete and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other re-quired fields. 3
• Assist researchers to coordinate, facilitate and prepare site for monitoring visits and FDA audits. Creates and updates protocol operating policies and procedures eg MOPs as needed.
• Verify study participant information and collect data and results of testing.
• 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
• 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 in the design of participant Case Report Forms (CRFs).
• 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.
• Documents, collects, records, and retains all research related participant encounters including in person, phone, or electronic in the research record eg 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.
• Collaborates with principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugs, biologics, and devices.
• 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.
• 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.
• 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
• 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.
• 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.
• Notes trends in toxicities, participant information, and data collection points.
• Creates and updates protocol operating policies and procedures eg MOPs as needed.
• Identifies and develops relationships with institutional or community-based resources or groups that can assist in achieving recruitment 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 eg 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.
• Participates in developing recruitment materials with input of investigators and IRB approval for referral sources outlining eligibility information.
• Performs and or coordinates outreach activities, as appropriate to meet research recruitment and enrollment goals.
• Collaborates with principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugs, biologics, and devices.
• 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.
• Collect participant data; obtain informed consent/assent; respond to and report variances in protocol implement; collect and record research information, perform research procedures as qualified and assigned. - Ad-Hoc
• Manage conflicts/issues in clinical research setting; assess participants and families; provide verbal responses to participants and families; respond to inquiries from the general public and health care professionals regarding clinical research protocols. - Ad-Hoc
• Contribute to interdisciplinary teams, participate in meetings, workgroup processes; provide substantive outcomes; complete assignments within established timeframes. - Daily
• Educate participants and families; perform individualized teaching; advocate and support participants' rights; identify learning needs for practice environment; explore and communicate research issues. - Ad-Hoc

Basic Qualifications:

• Bachelor’s degree in misc. health and medical professions, nursing, community and public health, general medical and health services, neuroscience, misc. biology, cognitive science and biopsychology, genetics, health and medical preparatory programs, nutrition sciences, pharmacy and pharmaceutical sciences and administration, treatment therapy professions, communication disorders sciences and services, sociology, misc. social sciences, interdisciplinary social sciences, misc. psychology, clinical psychology, social psychology, social work, chemistry, multidisciplinary or general science.
• Skilled in Microsoft Office Suite and general data acquisition programs.
• Experienced in 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, electronic medical records, and protocol review revision.
• Phase I or II experience and previous clinical trial work.
• Experienced in patient confidentially, remote site monitoring, regulatory compliance, protocol development, clinical research, protocol writing, clinical trials, data monitoring, data integrity, patient care, recruitment, scheduling, screening, research, ICH/GCP, and SOPs.

Minimum Qualifications:

• Ability to multi-task and pay close attention to detail.
• Excellent analytical, organizational and time management skills.
• Strong communication skills, both oral and written.

*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.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

This position is contingent upon contract award.