Clinical Advisor
1 month ago
- Provide project management of day-to-day DAIDS TMF activities including but not limited to coordinating and leading meetings, and discussions regarding all aspects of trial master files.
- Serve as the primary reviewer of TMF deliverables including but not limited to standard TMF reports, TMF messages, and TMF documents in electronic systems.
- Manage and design TMF related trainings for DAIDS and collaborators and present proposals/materials to the federal client for approval prior to implementation.
- Coordinate and communicate to provide support and guidance to various functional areas supporting DAIDSTMFs.
- Provide support of DAIDS TMF operations during TMF implementation, audits, and/or regulatory inspections.
- Ensure TMF's are "inspection ready at all times and TMF documents are filed contemporaneously.
- Monitor and identify trends, communicate issues, and recommend policy and procedural changes to improve operations to the federal client prior to implementation.
- Represent DAIDS on working groups and committees to communicate information regarding TMF policies, procedures, and requirements.
- Provide guidance, consultation and expert advice on regulations, policies and procedures to DAIDS staff and collaborators.
- Establish quality assurance standards and metrics for TMF policies and procedures.
- Ensure DAIDS compliance with all regulations, policies and procedures related TMFs.
- Participate in working groups and team meetings, as required.
- Develop SOPs as required to ensure oversight of the DAIDS TMF process.
- BS degree is required, MS preferred.
- Minimum of 3-5 years of TMF specific experience is required.
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Clinical Advisor
4 weeks ago
Rockville, United States GAP Solutions, Inc. Full timePosition Objective: Provide services as a Clinical Advisor in support of the overall functions of the Division of AIDS, Office of Clinical Site Oversite (OCSO), Asia and the Americas Branch (AAB) within the National Institute of Allergy and Infectious Diseases (NIAID).Duties and Responsibilities:Implement and coordinate a range of individual clinical...
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Clinical Advisor
4 weeks ago
Rockville, United States GAP Solutions, Inc. Full timePosition Objective: Provide services as a Clinical Advisor in support of the overall functions of the Division of AIDS, Office of Clinical Site Oversite (OCSO), Asia and the Americas Branch (AAB) within the National Institute of Allergy and Infectious Diseases (NIAID).Duties and Responsibilities:Implement and coordinate a range of individual clinical...
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Clinical Advisor
3 weeks ago
Rockville, United States GAP Solutions Inc Full timePosition Objective: Provide services as a Clinical Advisor in support of the overall functions of the Division of AIDS, Office of Clinical Site Oversite (OCSO), Asia and the Americas Branch (AAB) within the National Institute of Allergy and Infectious Diseases (NIAID). Duties and Responsibilities: + Implement and coordinate a range of individual...
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Clinical Advisor
1 week ago
Rockville, United States GAP Solutions Inc Full timePosition Objective: Provide services as a Clinical Advisor in support of the overall functions of the Division of AIDS, Office of Clinical Site Oversite (OCSO), Asia and the Americas Branch (AAB) within the National Institute of Allergy and Infectious Diseases (NIAID). Duties and Responsibilities: + Implement and coordinate a range of individual...
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Clinical Advisor
3 days ago
Rockville, United States GAP Solutions, Inc. (GAPSI) Full timePosition Objective: Provide services as a Clinical Advisor in support of the overall functions of the Division of AIDS, Office of Clinical Site Oversite (OCSO), Asia and the Americas Branch (AAB) within the National Institute of Allergy and Infectious Diseases (NIAID). Duties and Responsibilities: Implement and coordinate a range of individual...
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Clinical Advisor
1 week ago
Rockville, United States Columbus Technologies Full timeOverview: Must be a US Citizen or Green Card Holder W2 with full benefit Some travel may be required Offer contingent on ability to successfully pass a background check and drug screen Columbus Technologies and Services Inc. is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the...
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Rockville, United States Axle Full time(ID: 2024-5250) **Benefits**: - 100% Medical, Dental & Vision Coverage for Employees - Paid Time Off (Including Holidays) - Employee Referral Bonus - 401K Match - Tuition reimbursement and professional development opportunities - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program...
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Clinical Advisor
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Rockville, United States Axle Full time(ID: 2024-5258) **Benefits**: - 100% Medical, Dental & Vision Coverage for Employees - Paid Time Off (Including Holidays) - Employee Referral Bonus - 401K Match - Tuition reimbursement and professional development opportunities - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program...
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Clinical Advisor
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Rockville, United States RJ IT Solutions Full timeRJIT Solutions is an information technology and bioscience company that specializes in providing innovative solutions in biomedical research and data science. We serve healthcare organizations by leveraging the expertise of our team in science, software engineering, program/project management. Our commitment to excellence has made us a trusted partner of top...
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Clinical Advisor
1 month ago
Rockville, United States RJ IT Solutions Full timeRJIT Solutions is an information technology and bioscience company that specializes in providing innovative solutions in biomedical research and data science. We serve healthcare organizations by leveraging the expertise of our team in science, software engineering, program/project management. Our commitment to excellence has made us a trusted partner of top...
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Clinical Advisor
17 hours ago
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Clinical Advisor
1 week ago
Rockville, United States RJ IT Solutions Full timeRJIT Solutions is an information technology and bioscience company that specializes in providing innovative solutions in biomedical research and data science. We serve healthcare organizations by leveraging the expertise of our team in science, software engineering, program/project management. Our commitment to excellence has made us a trusted partner of top...
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Clinical Advisor
1 month ago
Rockville, United States RJ IT Solutions Full timeRJIT Solutions is an information technology and bioscience company that specializes in providing innovative solutions in biomedical research and data science. We serve healthcare organizations by leveraging the expertise of our team in science, software engineering, program/project management. Our commitment to excellence has made us a trusted partner of top...
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Clinical Advisor
2 days ago
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Clinical Advisor
1 month ago
Rockville, United States Axle Full timeJob DescriptionJob Description(ID: 2024-5250)Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program...
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Clinical Advisor
1 month ago
Rockville, United States Axle Full timeJob DescriptionJob Description(ID: 2024-5238)Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program...
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Senior Clinical Research Advisor
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Senior Clinical Research Advisor
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Rockville, United States Axle Full timeJob DescriptionJob Description(ID: 2024-4914)Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management,...
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Advisor in Bioinformatics
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Rockville, United States National Institutes of Health Full timeJob Summary The Advisor in Bioinformatics will provide leadership in the use of innovative methodologies, statistical design, and data science for surveillance research at the NCI and NIH. The incumbent will also provide consultation to Institute leadership in establishing policies involving highly complex, novel statistical support for research with...
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Advisor in Bioinformatics
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Rockville, United States National Institutes of Health Full timeJob Summary The National Cancer Institute (NCI) is seeking a well-established expert in cancer and biomedical research and medical decision modeling to serve as the Advisor in Bioinformatics in the Surveillance Research Program (SRP), Division of Cancer Control and Population Sciences (DCCPS). The NCI is the principal agency of the Federal Government for...