eNewsletter Signup
Miles
Km80.5

Human Subject Protection Team Lead

Technical Resources International Inc.

E-Mail to a Friend Add to Job Folder View All Jobs Back to Search Results Share
Location: Bethesda, MD Posted Date: 4/15/2013 Position Type: Full time Job Code: 201330 Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Research
Regulatory Affairs

Description

•   Prepare and maintain Informed Consent Templates used to prepare Sample Informed Consents
•   Perform regulatory review of the protocol sample informed consent and the informed consent submitted by clinical sites
•   Prepare, update, and maintain lists of risks associated with study agents and with patient management guidelines for adverse events
•   Plan and conduct training sessions at national and international meetings on informed consents
•   Respond to international requests for implementation of non-US regulations for overseeing the IC process
•   Manage high level quality control review of informed consent to assure compliance with Food and Drug Administration requirements and guidelines
•   Manage the revisions of SOPs and Work Instructions as necessary
•   Manage special client requests as assigned
•   Train new staff on IC process
•   Other duties as assigned

Requirements

•   B.S. or M.S. degree or equivalent related work experience
•   Minimum of 5-8 years regulatory or related work experience
•   Ability to review clinical protocols
•   Working knowledge of 21 CFR 50, Protection of Human Subjects, 21 CFR 56, Institutional Review Boards, and 45 CFR 46, Protection of Human Subjects
•   Excellent oral, written, and interpersonal skills
•   Working knowledge of word processing, spreadsheet, and database management programs

Submit resume with salary requirements to Attn: JK, TRI, 6500 Rock Spring Dr, Suite 650, Bethesda, MD 20817, or fax to (301) 897-1702, or email to hr@tech-res.com

Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.
E-Mail to a Friend Add to Job Folder



By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.

ADVERTISEMENTS