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Position Objective: Provide services as a Community Brain Health Study Research Coordinator in support of the overall functions of National Institute on Aging within the National Institutes of Health (NIH). The contractor will independently provide support services to satisfy the operational objectives of the Brain Health Equity (BHE) Unit within the Health Disparities Research Section (HDRS) at the National Institute on Aging (NIA). The primary objective is to provide services and deliverables by performing day to-day management of a developing community-based cohort study under the direction of Dr. Indira Turney, the Principal Investigator.

Duties and Responsibilities:

• Assist preparing and submitting for review accurate source documents related to all research procedures.

• 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.

• 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.

• Assist researchers develop, maintain and complete study data collection forms and source documents.

• 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.

• Assist researchers with the collection and analysis of research data and samples. 5

• 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.

• 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.

• Assist researchers develop and maintain current and new research protocols.

• Develop and nurture relationships with community stakeholders, such as religious leaders, community organizers, and local advocates, to build trust and engagement within the study’s target population. This includes attending community meetings and events to promote the study and encourage enrollment. 1

• Establish long-term partnerships with local organizations and institutions to ensure sustained community support and participant retention throughout the study. 2

• Work with investigators to Assist researchers submit protocol packages, actions and applications to IRB using the designated protocol tracking and management databases system.

• 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.

• Work with investigators to maintain Protocol Applications within the protocol management database system.

• Coordinate with relevant parties regarding data sharing plan review and tracking of data submission per approved plans.

• Maintain and organize an online resource of documentation regarding clinical trials, including Standard Operating Procedure documents for all tasks related to the handling of clinical trials.

• 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. 4

• Assist staff on all facets of clinical studies including subject enrollment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample collection and data entry. 3

• 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.

• Prepare and submit for review accurate source documents related to all research procedures.

• Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB).

• Develop and maintain research protocol documentation and operations.

• Assist researchers with study testing, observations data entry and other duties associated with study sessions.

• 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.

• Mentor new clinical research coordinators on all aspects of research support.

• Protocol Documentation: Work products related to the development and enforcement of study protocols.

• Documentation related to IRB compliance, including adverse event reporting and consent document updates.

• Manual: A complete and up-to-date operations manual, along with records of updates and revisions.

• Collaborator Engagement: Organize and develop partnerships with stakeholders across various sectors and different members of the community, including participants. (Weekly).

  Basic Qualifications:

• Masters Degree in Public Health, Epidemiology, Clinical Research, Neuroscience, Community and Public Health, Cognitive Science and Biopsychology, or a related field.

• Clinical Research Coordinator Certification (CCRC) or an equivalent qualification.

• Basic Life Support Certification.

• Skilled in RedCap.

• Extensive experience managing community-based epidemiological studies, particularly within historically marginalized communities.

• In depth knowledge of Institutional Review Board (IRB) regulations and Good Clinical Practice (GCP) guidelines - Expertise in designing, implementing, and conducting community-based longitudinal epidemiologic studies, demonstrated by CCRC certification or equivalent training.

• The ability to work independently, make informed decisions, and manage complex research operations.

• Strong communication, project management, and leadership skills - Mastery of the theory and methods involved in planning, designing, implementing, operating, analyzing, and assessing cross-sectional, longitudinal, and epidemiological studies, particularly in biomedical and behavioral research.

• Proficiency in writing study protocols and research-related documents, with expert knowledge of clinical trial practices and regulations.

• Ability to summarize and present scientific research, including statistical analyses, both verbally and in writing.

• Expertise in selecting and applying techniques for recruiting and retaining difficult-to-sample and vulnerable populations.

• A valid Maryland driver’s license with a good driving record.

• Ability to lift and carry up to 30 pounds.

  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.

Requisition ID: 7177