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POST DATE 12/5/2019
END DATE 1/3/2020
UT Southwestern Medical Center
JOB DESCRIPTIONEXPERIENCE AND EDUCATION
Master s degree, or equivalent, and two (2) years of related experience required. Regulatory Affairs Certificate (RAC) preferred.
Works under minimum supervision and is responsible for the management and strategy of a product through the regulatory process.
- Writes, reviews, and advises documents requires for submitting regulatory filings with the FDA for biologic products, drugs and device
- Directs, reviews, and advises investigators for the development, submission, and maintenance, of investigator sponsored INDs, including writing, submitting, and managing several pre-IND meetings with the FDA for new programs. Able to direct the compilation and assembly of INDs under eCTD format.
- Reviews, advises, and directs research to assure compliance with federal regulations relating to human subject research and/or animal care and use. Understands and applies ethical principles and multiple regulations to complex scientific research projects.
- Writes and reviews study protocols, informed consent documents, response to stipulations, and other study-related documentation, to assure conformance with all applicable requirements.
- Provides working supervision, training, and guidance to lower-level Regulatory Assistants. Assign tasks and set work priorities. Review work for accuracy.
- Administers expedited and exempt research review processes, including, but not limited to: intake of protocols and assessment of review level (with referral to full IRB/IACUC, when applicable); regular one-on-one meetings with IRB/IACUC Chairs for final determinations; drafting correspondence to investigators regarding IRB/IACUC determinations.
- Provide consultation and technical assistance to investigators and study personnel regarding requirements for IRB/IACUC submissions, performance of studies, and documentation of compliance. Serve as an information resource to the campus about human subject protection and/or animal care and use.
- Performs other duties as assigned.
KNOWLEDGE, SKILLS, & ABILITIES
- Work requires excellent verbal, written, and interpersonal communication skills to work effectively with all levels of staff, faculty, and scientists.
- Work requires ability to read, write, analyze data, develop plans and procedures, and coordinate resources to accomplish goals.
- Work requires ability to provide technical assistance and consultation to physicians and other scientists.
- Work requires responsibility for review, recommendation, development, and implementation of policies.
- Work requires computer proficiency and comfort with electronic technology for data management.
Any qualifications to be considered as equivalents in lieu of stated minimum require prior approval of Vice President for Human Resources Administration or his/her designee.
Work is performed primarily in office area.
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. In accordance with federal and state law, the University prohibits unlawful discrimination, including harassment, on the basis of: race; color; religion; national origin; sex; including sexual harassment; age; disability; genetic information; citizenship status; and protected veteran status. In addition, it is UT Southwestern policy to prohibit discrimination on the basis of sexual orientation, gender identity, or gender expression..