CLINICAL RESEARCH REGULATORY COORDINATOR II - (T187190)
To prepare, submit, and assist with multiple levels of research documentation
(i.e. IRB submissions, educational materials, reports, grant renewal reports,
and study forms). To maintain regulatory documentation including consent
forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment
materials, safety reports, and submission forms. To draft informed consents.
To prepare and maintain FDA applications for Investigational New Drugs
(INDs) and Investigational Device Exemptions (IDEs). To assist in drafting
compliant advertisements.To serve as resource person or act as consultant
within area of regulatory expertise.
Prepare, submit, and assist with multiple levels of research documentation,
IRB submissions to UAB, WIRB, Advarra, and others. Maintain regulatory
documentation including ICF, protocol, 1572, CV's, ML, IB, recruitment
materials, submission forms, draft informed consents. Maintain/prepare FDA
applications for Investigational New Drugs (INDs) and Investigational Device
Exemptions (IDEs). To serve as resource person or act as consultant within
area of regulatory expertise.
Perform other duties as assigned.
(Annual Salary Range: $47,486.40 - $74,484.80)
Bachelor's degree in a related field and three (3) years of related
experience required. Work experience may substitute for education requirement.
Advanced knowledge in regulatory related to clinical trials and retrospective
IRBs. Basic knowledge of clinical trials.gov, consenting, and protocol review,
adverse and serious adverse event reporting. Ability to work independently, to
make decisions, to interact with sponsors, regulatory authorities and
investigators. Ability to communicate effectively with physicians, sponsors
and other collaborators.
: Clinical Research
: 310008400 Comprehensive Cancer Center
Shift: Day/1st Shift