97136 Regulatory Specialist
Regulatory Specialist needed for a 6-month contract-to-perm position
REQUIRED:
Successful candidate to have the following:
Bachelors' degree in Biological Science, Social Sciences, English, or other related field.
Working knowledge of Federal, State, and Local Regulations, IRB requirements and submissions, consent form writing, and protocol development.
Oncology clinical trials experience desired.
Strong technical skills including MS Office, general computer proficiency.
Excellent skills in time management, prioritization, and multi-tasking required.
Excellent skills (both written and oral) required.
Job Description:
You will responsible for collaborating with the PI's, Clinical Research Coordinators, Senior Clinical Research Coordinators and/or Sr. Managers with all aspects of clinical trial regulatory submission and compliance. Assist in preparing regulatory submissions and maintaining the regulatory files. Coordinate the preparation of regulatory documents for submission to the Institutional Review Board (IRB) or other IRB's as determined, other internal committees and the FDA as necessary including but not limited to: Initial documents submission; Continuing Reports; Amendments and addendums to research protocols and consent documents and Adverse Event reporting. Collaborate with study team members to perform these duties. Assist in maintaining master regulatory files in accordance with institutional, state and federal regulations.
Estimated Salary: $20 to $28 per hour based on qualifications.
REQUIRED:
Successful candidate to have the following:
Bachelors' degree in Biological Science, Social Sciences, English, or other related field.
Working knowledge of Federal, State, and Local Regulations, IRB requirements and submissions, consent form writing, and protocol development.
Oncology clinical trials experience desired.
Strong technical skills including MS Office, general computer proficiency.
Excellent skills in time management, prioritization, and multi-tasking required.
Excellent skills (both written and oral) required.
Job Description:
You will responsible for collaborating with the PI's, Clinical Research Coordinators, Senior Clinical Research Coordinators and/or Sr. Managers with all aspects of clinical trial regulatory submission and compliance. Assist in preparing regulatory submissions and maintaining the regulatory files. Coordinate the preparation of regulatory documents for submission to the Institutional Review Board (IRB) or other IRB's as determined, other internal committees and the FDA as necessary including but not limited to: Initial documents submission; Continuing Reports; Amendments and addendums to research protocols and consent documents and Adverse Event reporting. Collaborate with study team members to perform these duties. Assist in maintaining master regulatory files in accordance with institutional, state and federal regulations.
Estimated Salary: $20 to $28 per hour based on qualifications.
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