Clinical Research Regulatory Coordinator II
The University of Alabama at Birmingham (UAB), Department of Med - Infectious Diseases, is seeking a Clinical Research Regulatory Coordinator II. This position will be the resident expert and production line for all human subjects-related compliance tasks for both local and global clinical projects for 7 clinical research faculty. The CRRC II will work with a various degree of independence to prepare, submit maintain regulatory research documentation for all clinical studies abroad as well as in the United States
General Responsibilities
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.
Key Duties & Responsibilities
50% Working with leadership and IRB to determine the best approach for individual and unique human subjects projects as well as clinical trials. Writing and submitting developmental approvals, protocols, responses, renewals, amendments, and problem reports; assisting with human subjects sections of grant applications and grant progress reports.
10% Corresponding with sponsors and management teams regarding the studies; attending study meetings and conference calls; serving as clinical coordinator.
5% Maintaining Study Binders.
5% creates and maintains clear, easy-to-navigate IRB files, deadlines, and dashboards.
5% Manage/maintain clinical trials.gov accounts.
5% Attend training and seminars offered on all clinical study concepts and IRB seminars.
5% Mentor/train graduate students for individual IRB submissions.
5% Manage Material Transfer agreements when required.
5% Initiate and maintain Oncore for local clinical trials.
Performs other duties as assigned.
Annual Salary Range:
$47,665 - $77,455
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.Estimated Salary: $20 to $28 per hour based on qualifications.
General Responsibilities
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.
Key Duties & Responsibilities
50% Working with leadership and IRB to determine the best approach for individual and unique human subjects projects as well as clinical trials. Writing and submitting developmental approvals, protocols, responses, renewals, amendments, and problem reports; assisting with human subjects sections of grant applications and grant progress reports.
10% Corresponding with sponsors and management teams regarding the studies; attending study meetings and conference calls; serving as clinical coordinator.
5% Maintaining Study Binders.
5% creates and maintains clear, easy-to-navigate IRB files, deadlines, and dashboards.
5% Manage/maintain clinical trials.gov accounts.
5% Attend training and seminars offered on all clinical study concepts and IRB seminars.
5% Mentor/train graduate students for individual IRB submissions.
5% Manage Material Transfer agreements when required.
5% Initiate and maintain Oncore for local clinical trials.
Performs other duties as assigned.
Annual Salary Range:
$47,665 - $77,455
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.Estimated Salary: $20 to $28 per hour based on qualifications.
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