The Henry M. Jackson Foundation for the Advancement of Military Medicine has an immediate opening for a Clinical Trials Administrator. They are seeking a detail-oriented professional with strong management skills to coordinate all aspects of clinical trials development, interacting with investigators and research site personnel and interfacing with representatives of pharmaceutical companies, government agencies and research institutions. Responsibilities include preparing IRB applications and consent forms, negotiating budgets and contracts, seeking funding opportunities, and providing administrative support for investigators. Require a BS/BA in Health Sciences or related field; ability to use word processing, spreadsheet, database software and Internet; experience in clinical research environment preferred. Military experience and/or familiarity with military medicine a plus. The Henry M. Jackson Foundation is a private, non-profit organization providing support services to the military medical community and offer a competitive salary and generous benefits package. A copy of the complete position description is attached to the end of this message. At this time, the search is restricted to the greater Baltimore, MD/Washington, DC area. If you are interested in this position, please send a cover letter and resume to: Human Resources Department, Attn: #000419 Henry M. Jackson Foundation for the Advancement of Military Medicine 1401 Rockville Pike, Suite 600 Rockville, MD 20852 or e-mail to xxxxxx@hjf.org EEO/AA The Henry M. Jackson Foundation for the Advancement of Military Medicine Position Description Clinical Trials Administrator Position No: 4061 FLSA Status: Exempt Grade: 6 EEO Category/Job Group: C/203 Job Summary: Responsibilities are to administer single and multicenter, industry and/or federally sponsored research projects. Essential Job Duties: 1. Responsible for managing individual site clinical research programs. 2. Coordinates interdepartmental and intradepartmental activities involved in clinical research including protocol approval, operational support, and regulatory submissions to Sponsor. 3. Write protocol applications and consent forms for Institutional Review Boards. Prepare and submit required institution and FDA documentation for the conduct of the trial. 4. Manage programs upon receipt of IRB approval. This includes preparing any addenda and/or annual progress reports, submitting adverse event/safety information to the IRB, updating/maintaining regulatory requirements such as updated investigator CVs, changes in principal investigator, FDA form 1572, etc. Also, maintain accurate, regulatory-compliant program/study binders. 5. Negotiate contracts and develop cost-per-patient study budgets. 6. Coordinate efforts of all agencies involved in the protocol approval process. These include: Departments of Clinical Investigation, the program/study sponsor, the National Institutes of Health, and various other agencies. Make and maintain contacts within the pharmaceutical industry. 7. Provide management support to the Principal Investigator, including participating in the initiation of investigative sites, screening and hiring research personnel, and serving as a general point of contact for the program/study. Nonessential Job Duties: 8. Perform other duties as needed. Job Specifications: Required Skills, Knowledge, and Abilities: Working knowledge of a broad range of medical specialties; working knowledge of all applicable federal and military regulations regarding the use of human and animal subjects in research (e.g.: 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 314, 45 CFR 46, FDA Form 1571, and FDA Form 1572). Must be familiar with Institutional Review Board activities and Institutional Biosafety Committee actions. Must be able to set and meet deadlines. Minimum Education/Training Requirements: Bachelor's degree. Physical Capabilities: Some lifting and walking. Supervisory Responsibilities/Controls: Supervise some administrative staff. Work Environment: Most of the work is done in a well-lighted, climate-controlled office. Visits to hospitals/clinics are required. Any qualifications to be considered to be equivalents, in lieu of stated minimums, require the prior approval of the Development Director, Clinical Trials Department. _________________________________________ Debra L. Drobek Grants Program Manager Office of Sponsored Programs Henry M. Jackson Foundation for the Advancement of Military Medicine 1401 Rockville Pike -- Suite 600 Rockville, MD 20852 Phone: (301) 294-7288 FAX: (301) 424-5771 E-mail: xxxxxx@hjf.org ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================
