Community Brain Health Study Research Coordinator

Axle•Baltimore, MD

2h•Hybrid

About The Position

Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. They work with top research organizations and facilities, including multiple institutes at the National Institutes of Health (NIH). Axle is seeking a Community Brain Health Study Research Coordinator to join their team at the National Institutes of Health (NIH), supporting the National Institute on Aging (NIA) located in Baltimore, MD. 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.

Requirements

Master’s degree in public health, epidemiology, clinical research, or a related field, or equivalent specialized experience.
Certification as a Clinical Research Coordinator (CCRC) or an equivalent qualification.
Basic Life Support Certification.
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.
The ability to lift and carry up to 30 pounds.
Extensive experience in conducting community outreach and managing community relationships, especially in historically marginalized communities, such as Black communities in urban settings.
Strong passion for and commitment to health equity research, demonstrated by previous experience working with underserved populations.

Nice To Haves

Preference for candidates who have shown a history of long-term engagement (3+ years) in previous roles, particularly in community-based research settings or relevant transferrable fields.

Responsibilities

Develop and enforce study protocols.
Prepare documentation related to IRB compliance, including adverse event reporting and consent document updates.
Maintain a complete and up-to-date operations manual, along with records of updates and revisions.
Organize and develop partnerships with stakeholders across various sectors and different members of the community, including participants.
Attend community meetings and events to promote the study and encourage enrollment.
Establish long-term partnerships with local organizations and institutions to ensure sustained community support and participant retention throughout the study.
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.
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.
Assist researchers with the collection and analysis of research data and samples.
Support clinical staff to develop, implement and maintain clinical research data files and materials.
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.
Collect research data and prepare information for inputs and analysis.
Verify study participant information and collect data and results of testing.
Assist staff to 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.
Support the development of forms and questionnaires.
Assist researchers to develop, maintain and complete study data collection forms and source documents.
Support 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 to screen prospective study subjects and participate in scheduling participants for research visits and procedures.
Monitor subject's progress and report adverse events.
Act as 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.
Exhibit creativity in drafting newsletter, coordinating newsletter printing and distribution, and organize care package assembly.
Support assembly, development and review of new research projects.
Assist key research personnel to ensure that clinical research activities are performed in accordance with federal, state and institutional regulations, policies and procedures.
Assist researchers to plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures.
Assist researchers to 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.
Support the creation and management of clinical websites and web-based tools.
Work with investigators to assist researchers submit protocol packages, actions and applications to IRB using the designated protocol tracking and management databases system.
Organize and perform 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.
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.
Provide assistance to staff in the collection, development and quality control of essential clinical research efforts.
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.
Develop and facilitate training to new research coordinators and mentor 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.
Research changes and updates to Good Clinical Practices (GCP) and prepare 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.