SOLICITATION NOTICE
R -- Clinical Trial Specialist
- Notice Date
- 5/10/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541611
— Administrative Management and General Management Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Nat'l Institute of Diabetes, Digestive, & Kidney Diseases, 2 Democracy Plaza, Suite 700W 6707 Democracy Blvd., MSC 5455, Bethesda, MD, 20892-5455
- ZIP Code
- 20892-5455
- Solicitation Number
- NIH-NIDDK-05-418
- Response Due
- 6/6/2005
- Archive Date
- 6/21/2005
- Point of Contact
- Patricia Haun, Purchasing Agent, Phone (301) 594-8855, Fax (301) 480-4226,
- E-Mail Address
-
haunp@extra.niddk.nih.gov
- Description
- The National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has a requirement to procure the services of a Clinical Trial Specialist. This position is full-time and is will be a Base Year with Four (4) Option Years. The service is to assist senior scientists in the Division of Diabetes, Endocrinology, and Metabolic Diseases (DEM) with the oversight and management of clinical trials and large-scale epidemiological studies in diabetes, endocrinology and metabolism. The primary responsibilities of this position include: 1. Prepare documentation of procedures for clinical trials management and data safety monitoring board to meet the needs of DEM, NIDDK, NIH and the researchers with whom they work as well as consumers, the federal government, or special interest groups. a. Apply knowledge of clinical trials and data safety monitoring board requirements in review, analysis, and critique of documentation, and make recommendations for changing the documentation to meet compliance with those requirements without changing the substance of the documents. b. Draft, review, and update DEM clinical trials and data safety monitoring board policies and procedure guidelines to assure compliance with current requirements. Prepare succinct directives to assure that researchers have the information needed to comply with requirements. c. Develop templates as appropriate to facilitate consistency in documentation and information collection. 2. As needed, prepare and maintain Investigational New Drug Applications and Investigation Device Exemption applications. a. Preparation of Investigational New Drug Applications (INDs) and Investigational Device Exemption (IDE) applications to the Food and Drug Administration (FDA) and if applicable, to foreign regulatory authorities. b. With assistance from established data coordinating centers, prepare IND annual reports to the FDA and if applicable, to foreign regulatory authorities. c. Ensure that all reportable Serious Adverse Events (SAEs) occurring during the conduct of collaborative clinical trials supported by DEM are transmitted to the FDA (and if applicable their foreign counterparts) in a timely manner. d. Correspond with regulatory authorities to maintain changes in study protocol and consent forms, addition of investigators and other information to keep the IND/IDE up to date. 3. In coordination with the Coordinating Center, if applicable, assist Program Officials with initiation and management of Data and Safety Monitoring Boards (DSMB) and Scientific Advisory Boards (SAC): a. To establish and maintain a central electronic database to archive documents pertaining to the following: I. Deliberations of DSMBs including meeting minutes, operating policies, II. The deliberations of SACs including meeting minutes, operating policies, III. Documents pertaining to these studies, including study protocols, rosters of DSMBs/SACs, etc. b. Assist in meeting planning, agenda development, generation of minutes, and follow-up of action items from Steering Committee meetings. c. Support dissemination of clinical trial and data safety monitoring board information to DEM customers through preparation of presentations, reports, and correspondence, and updating the website to assure accurate and timely information availability. 4. Assist Program Officials in the interface with the Office of Technology Development and Transfer, NIDDK and private sector collaborators to facilitate the execution of Clinical Trials Agreements, Material Transfer Agreements, and Cooperative Research and Development Agreements. 5. If needed, assists Program Officials in development of new study protocols. 6. Assists Program Officials in the clearance of international sites in cooperative agreements. 7. Assist Project Officials with budget monitoring of ongoing projects and development of budgets for new studies. 8. Interact with clinical trial investigators and the NIDDK Central Repository contractors to ensure timely archiving of biologic specimens and data. In addition, the clinical trials management specialist will work with investigators to ensure appropriate informed consent documents to permit archiving are developed and executed. 9. Maintain registration of clinical trials on clinicaltrials.gov. 10. For all of DEM, approves the DSMP and Safety Officer for all individual grants prior to the Program Official’s clearance for funding. Ensures that the Memo of DEM approval, the DSMP and the Safety Officer’s CV are placed in the official grant file. Qualifications: 1. Masters degree or equivalent in a field relevant to health sciences research. 2. At least 3 years of experience in clinical trials oversight or equivalent. 3. Evidence of skill in technical writing related to clinical trials. 4. Ability to organize and carry out multiple concurrent long term projects. All vendors that are capable of providing the Government with the services described above may request a copy of the Request for Quote (RFQ) in writing or by FAX to 301-480-4226 to the Contracting Office prior to the closing date of this notice. It is anticipated that RFQ NIH-NIDDK-05-418 will be available fifteen (15) days after the publication date of this synopsis. Receipt of quotations will be due ten (10) days after the release of the RFQ. The anticipated award date is June 10, 2005. Quotations must be submitted in writing to the National Institute of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Blvd., Room 774C, Bethesda, Maryland 20817 Attention: Patricia Haun. Fax quotations must contain offerors names, address, telephone number and fax number. FAX quotations will only be accepted if dated and signed by an authorized company representative. NOTE: THIS NOTICE WAS NOT POSTED TO WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (10-MAY-2005); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/NIDDKD/NIH-NIDDK-05-418/listing.html)
- Place of Performance
- Address: 9000 Rockville Pike Bethesda, MD
- Zip Code: 20872
- Zip Code: 20872
- Record
- SN00803949-F 20050512/050510212149 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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