Community Brain Health Study Research Coordinator

Deliverables:

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

• Compliance Reports: Documentation related to IRB compliance, including adverse event reporting and consent document updates. - Ad-Hoc

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

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

Statement of Work Details:

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

• 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.

• 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.

• 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.

• 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.

• 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.

• Exhibit creativity in drafting newsletter, coordinating newsletter printing and distribution, and organize care package assembly.

• Supports assembly, development and review of new research projects.

• 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.

• Supports 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.

• 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.

• 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.

• Provides 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.

• 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.

• 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.

• 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.

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