| Experience & Education Required
(any one of the following): |
1. Master's degree in related field and one (1) year research data
management and patient interviewing experience in delivery of
health care services or experience in behavioral, social science,
or clinical applied research.
2. Bachelor's degree in related field and three (3) years research
data management and patient interviewing experience in delivery of
health care services or experience in behavioral, social science,
or clinical applied research.
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| Job Duties |
1. Develops, coordinates, and reviews research study procedures to
ensure receipt, completeness, and accuracy of research data
required for studies.
2. Coordinates all regulatory aspects, such as preparing safety
reports, adverse events, FDA compliance, drug company monitoring,
laboratory standards; and laboratory standards; maintains databases
related to these regulatory aspects.
3. Coordinates aggregation and maintenance of local and national
research data required to ascertain and identify research study
outcomes; oversees and may perform entry of research data, coding,
retrievals, adjustments, additions, and computer backups.
4. May develop and monitor budgets; negotiates participant rates;
approves expenditures; pays invoices; reconciles accounts
associated with studies.
5. Develops and prepares statistical research reports, charts, and
graphs as required during research studies.
6. Assists in design of research survey forms to capture required
participant information; interviews research study subjects and/or
family members to gather research study information.
7. Develops procedures to determine subject eligibility; screens,
recruits, and enrolls subjects, ensuring and documenting proper
informed consent; tracks subjects' information from multiple
projects. Prepares informed consent forms for subjects' families.
8. Coordinates collection and data management of national research
studies from multiple projects by interacting with internal and
external research data managers, patients, and physicians for
coordination of tissue samples, lab data and protocols, and other
statistical information concerning research study subjects.
9. Serves as primary liaison and prepares annual reports for federal,
state, and/or local agencies. Informs Institutional Review Board of
amendments to research studies; prepares protocols and detailed
summaries in lay terms of any new research study.
10. May provide full supervision to personnel of lower grade.
11. Performs other duties as assigned.
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