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HJF is seeking a Clinical Trials Specialist II (CTS II) responsibilities in the Clinical Operations Office (COO) include clinical research/trial protocol development/implementation and management of U.S. Military HIV Research Program (MHRP) clinical research being conducted within the US and internationally. The incumbent will prepare protocol development work plans, schedule and monitor study timelines during protocol development and review process in coordination with the protocol chair and team, study sponsor, and/or collaborative institution(s). CTS II will coordinate all aspects of protocol and related documents development including but not limited to: development of a final protocol and submission documents that meet all regulatory requirements set forth by the US Department of Defense (DoD), Institutional Review Boards/Ethics Committees (IRBs/ECs) and Regulatory/Health agencies (RA/HA) located at respective international participating sites. The incumbent will anticipate, identify and resolve problems that may delay study initiation and progression, assemble a protocol team and facilitate protocol team communication throughout study duration. In addition to protocol development, the CTS II will manage site activation procedures to include travel to sites to conduct training of site personnel on study, review and approval of site readiness, and develop protocol tools as necessary to assist participating sites in the conduct of clinical studies. Performs other duties as assigned.
Required Knowledge, Skills, and Abilities: Ability to compile, edit and write protocol documents and progress reports in a clear and concise manner. Ability to work in a fast-paced research environment, and to plan and manage multiple priorities on different timelines. High level of initiative and ability to work with minimum supervision. Ability to quickly and effectively resolve complex issues. Flexibility to handle a variety of tasks and shift priorities as necessary. Excellent organization, time and project management skills with strong communication and interpersonal skills. Ability to effectively interact with local and international external collaborators in a culturally sensitive manner. Ability to work as an effective team member in a virtual environment.
Knowledge of PCs and Macs. Basic knowledge of human anatomy, physiology, infectious diseases and immunology highly desirable.
Minimum Education/Training Requirements: Bachelors Degree
Minimum Experience: 2 to 4 years of Clinical Research Experience
Physical Capabilities: Long periods of standing and sitting
Work Environment: Office environment. May be required to travel to international sites 10-15% of time.
HJF is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Director of Human Resources.