Clinical Research Protocol Coordinator

About the Position: This position is located at Brooke Army Medical Center, San Antonio, Texas. This is a Direct Hire Solicitation Salary negotiation may be available for those candidates who are new to Federal service.

Major duties

• Protect human subjects by advising prospective investigators on complex requirements for protocol development.
• Review draft protocol submitted by investigators to ensure it complies with federal regulations.
• Summarize detailed minutes of each meeting in accordance with written requirements for Institutional Review Board proceedings.
• Maintain protocol files with all required documentation in accordance with federal regulations.
• Answer inquiries from prospective investigators to assist them in meeting all requirements.
• Direct complex medical research questions to the appropriate consultant.
• Serve as administrative coordinator for the Institutional Review Board.
• Review draft protocols, informed consent forms, HIPPA documents, and corresponding submission documents submitted by investigators to ensure it complies with federal regulations.
• Establishprotocol files with all the required documentation on new submissions, revisions, adverse events, continuing reviews, consent forms, and HIPAA documents in accordance with all Federal regulations.
• Manage the administrative review of the protocol life cycle actions.

Qualifications

Who May Apply: US Citizens In order to qualify, you must meet the education and/or experience requirements described below. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community; student; social). You will receive credit for all qualifying experience, including volunteer experience. Your resume must clearly describe your relevant experience; if qualifying based on education, your transcripts will be required as part of your application. Additional information about transcripts is in this document. Specialized Experience: One year of specialized experience equivalent to the GS-07 grade level in the Federal service which includes coordinating with various clinical investigation departments, research committees and investigators; utilizing protocol development; reviewing clinical research protocols; interpreting federal regulations used for human research subjects and experience working with clinical research protocol record maintenance, and working with an electronic submission system for research protocols such as eIRB. OR Education: Master's or equivalent graduate degree or 2 full years of progressively higher-level graduate education leading to such a degree in a field which demonstrates the knowledge, skills, and abilities necessary to do the work of the position. (NOTE: You must attach a copy of your transcripts for verification). OR Combination of Education and Experience: A combination of education and experience may be used to qualify for this position as long as the computed percentage of the requirements is at least 100%. To compute the percentage of the requirements, divide your total months of experience by 12. Then divide the total number of completed graduate semester hours (or equivalent) beyond the first year (total graduate semester hours minus 18) by 18. Add the two percentages. (NOTE: You must attach a copy of your transcripts for verification).

Education

FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: https://sites.ed.gov/international/recognition-of-foreign-qualifications/.