Job Title: Community Brain Health Study Research Coordinator
Location: Baltimore MD 21224
Duration: 02 Years to long term
Shift: Standard Shift (40 Hours/Week)
Onsite: Yes
Teleworking Eligible: Yes
Job Description:
- 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).
- The primary objective is to provide services and deliverables by performing day to-day management of a developing community-based cohort study.
Min Education:
Certifications & Licenses:
- 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
Required Skills:
- Extensive experience managing community-based epidemiological studies, particularly within historically marginalized communities.
- 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
- Expertise in designing, implementing, and conducting community-based longitudinal epidemiologic studies, demonstrated by CCRC certification or equivalent training
- 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.
- In-depth knowledge of Institutional Review Board (IRB) regulations and Good Clinical Practice (GCP) guidelines
- 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
- Extensive experience in conducting community outreach and managing community relationships, especially in historically marginalized communities, such as Black communities in urban settings.
Software:
- Redcap
- Electronic Medical Records System
- Electronic Data Capture System
Field of Study:
- Community and Public Health
- Cognitive Science and Biopsychology
- Neuroscience
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.
- 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 spread sheets 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.
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.
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.
- 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.
- 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.
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22nd Century Technologies, Inc.
$90K-$95K/Yearly
Nov 22, 2024