| Human Subjects Protection Scientist -- Silver Spring, MD |
Author: Jon Merz
Date: 03-03-10 18:42
HUMAN SUBJECTS PROTECTION SCIENTIST
Clinical Research Management, Inc. (CRM) is a Government Contractor specializing in infectious disease research in the U.S. and aboard. CRM provides GxP services, research personnel, and support services, contributing to the development of vaccines, drugs, and devices, to help prevent, diagnose, and treat human disease. CRM has an immediate need for a Human Subjects Protection Scientist in Silver Spring, MD.
RESPONSIBILITIES
1. Assist the Institutional Review Board (IRB) Administrator with the administration of the human subject's protection function of a life sciences research institute.
2. Evaluate research protocols for compliance with relevant regulatory requirements.
3. Recommend revision to policies in the handling and documentation of the FDA-regulated investigational products.
4. Represent the ORM in meetings pertaining to human subject protection issues, as needed.
5. Perform staff assistance visits to WRAIR laboratories, as needed.
6. Document credentials of investigators.
7. Assure quality of records of protocol implementation.
8. Provide training in human subject's protection and quality of records to investigators and other staff.
9. Provide technical assistance to CRM Headquarters as needed and participate on proposal writing projects when requested.
10. Provide all job-related progress reports/technical reports as requested.
11. Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
12. Performs light duties and other related duties as required and assigned.
REQUIRED SKILLS / EXPERIENCE
1. M.A./M.S. in relevant scientific field with human subject's protection experience or R.N. with B.S. and clinical trials experience.
2. Proficiency in the use of office computer software.
3. Required Knowledge, Skills and Abilities: knowledge of applicable highly complex scientific/office procedures and techniques relating to position.
4. Must be able to work independently following a brief period of specific technical training.
5. Must be a US Citizen or Permanent Resident.
ATTRIBUTES
CRM currently offers the following benefits to full-time employees:
* Paid vacation, sick and holiday leave.
* Up to $3,000/year for Tuition Assistance.
* Up to $500/year for Professional Development Assistance.
* Health, Life & Disability Insurance.
* 401k Retirement Plan with Employer Match.
* Flexible Spending Accounts
* Voluntary Benefits - Dental, Short-Term Disability & Supplemental Life Insurance.
* Other Benefits.
Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under CRM's contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.
CRM is an Affirmative Action-Equal Opportunity Employer
* Please submit only one resume per position.
** Contact will only be made if there is further interest.
*** All posted opportunities are full-time, unless otherwise stated.
**** All candidates can apply at www.clinicalrm.com under the career opportunities section by selecting the position of interest and then the "apply to this job" link at the bottom of the job posting.
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