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Regulatory Associate specializing in Human Subjects Protection

Technical Resources International Inc.

Location:
Bethesda, MD
Posted Date:
9/9/2014
Position Type:
Full time
Job Code:
201219
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Clinical Research, Regulatory Affairs,

Job Description

Founded in 1979, Technical Resources International, Inc. (TRI) is a Contract Research Organization that provides a unique range of support services in the areas of Health, Communications, and Information Technology to both private industry and government agency clients. TRI is currently seeking a Regulatory Associate specializing in Human Subjects Protection to join our Bethesda, MD team in supporting large global clinical trial portfolios.

This position will act as a Clinical Research Ethicist, providing expertise on the implementation of relevant Human Subjects Protection regulations in clinical research.

Responsibilities include:
•   Conducting regulatory and bioethical reviews of clinical trial protocols, including domestic and international sample and site-specific informed consent documents, for compliance with applicable federal regulations and policies
•   Conducting literature reviews of ethical codes, regulations, and guidance documents relevant to human subjects protection in clinical research
•   Training and supervising staff on application of federal regulations
•   Developing, reviewing, and updating informed consent templates, SOPs and internal guidelines to promote high quality work products

Requirements

Requirements include a relevant PhD or a Master’s Degree with at least 2 years of experience in bioethics or a clinical research environment, and excellent writing and interpersonal skills. The ideal candidate will have a working knowledge of the Common Rule and other regulations/policies relevant to the protection of human subjects. Experience in medical writing, IRB activities, infectious diseases, working with HIV patients, and/or regulatory affairs is highly desirable.

Submit resume, cover letter and 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.

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