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

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