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Clinical Advisor - NIH - TRP/DAIDS

Company: Jobleads
Location: Bethesda
Posted on: May 3, 2021

Job Description:

Clinical Advisor - NIH - TRP/DAIDS in Bethesda, Maryland | Careers at CAMRIS International - Headquarters Skip to Main Content Please Enable Cookies to Continue Please enable cookies in your browser to experience all the personalized features of this site, including the ability to apply for a job. Welcome page Returning Candidate? Log back in! Clinical Advisor - NIH - TRP/DAIDS Job Locations US-MD-Bethesda # of Openings 1 Category NIAID Type Regular Full-Time Overview CAMRIS is a clinical and life sciences firm that realizes innovative solutions to challenges worldwide through high-quality, cost-effective program and research management services. We combine our proven systems with today's most effective, evidence-based best practices to improve the lives of people around the world.Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, bio-defense, and clinical research. CAMRIS attracts the next generation of scientists to work at premier government research and development institutions with state-of-the-art facilities and equipment, under world leaders in health research. Our exceptional benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, and life insurance. If you enjoy being a part of a high performing health and research organization dedicated to making the world a healthier place, please apply today! We are seeking a Clinical Advisor to support the overall functions of the TB Clinical Research Branch, Therapeutics Research Program, Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). Responsibilities Works with Branch Chief, Physicians, and Program Officers to: Review, participate in design/development, and oversee implementation of clinical trials for the treatment and/or prevention of TB and TB/HIV co-infection. o Evaluate the hypothesis, objectives, study design, feasibility, and regulatory requirements, as well as identifying medical and logistical problems that may impede a study. o Participate in clinical trial team discussion on selection and implementation of interventions, study design, evaluation of clinical events and endpoints, safety assessments, and assurance of participant safety. o Interact with investigators, statisticians, other DAIDS components and support contractors, product sponsors, and other agencies engaged in assigned research activities and related fields. o Review, assure necessary revisions, and approve drafts of trial protocol, informed consent, and important implementation documents (e.g., the Study Progress and Safety Monitoring Plan). o Provide subject matter expertise during protocol development leading to Program review and decision whether to approve, and ensure that the concerns raised during the review are addressed by the Protocol Development Team in a timely manner to allow final approvals. Monitor progress and conduct of projects, including protection and safety of participants in clinical trials. The incumbent reviews data, progress reports, and reports of events of critical deviations from protocol or regulations, and implements corrective actions needed to achieve adequate research. Advises program management of deficiencies and problems encountered during study implementation. Evaluate annual IND annual reports for implementation issues and medical safety and report findings to RAB and program management. Provide medical expertise in ongoing protocol follow-up stages for subject safety and protection, reliability of study endpoint data. Provide appropriate recommendations to DAIDS' leadership to ensure trials are conducted according to protocol, regulations and accepted standards. Provide clinical and scientific information for preparing NIAID communications to the Food and Drug Administration (FDA), other government and nongovernmental agencies, pharmaceutical companies. and Data Safety Monitoring Boards. Preview, revise as needed, and approve safety reports (IND and MedWatch to FDA and/or safety alerts or communications for investigators), provides expert medical advice for potential impact of adverse events in ongoing research. Produce documents, presentations, and responses to requests for information as required in planning and implementation of the clinical trials agenda. Liaison with other NIH ICs and other sponsors to ensure coordination, avoid unnecessary duplication, and to participate in collaborative efforts being conducted nationally and internationally Attends and participates in national/international scientific meetings/conferences in order to stay abreast of current research findings and to interact with other investigators to promote collaborations. Qualifications RN degree and active license, PA or NP certification strongly preferred or MD degree with completed training in Internal Medicine. Extensive experience in clinical care and in conduct and oversight of clinical trials, including evaluation of safety issues, demonstrating in-depth understanding of ICH/GCP/ best best practices, clinical trial regulations and requirements, ethics, and methodology; Clinical trial unit supervisory/management experience is preferred. All support positions required a minimum of a BS degree; some require a MS, MD, or Ph.D. The education, skills and relevant years of experience required for each support position are consistent with those identified as the minimum requirements for the labor categories specified in the contract. Options Apply for this job online Apply Share Refer this job to a friend Refer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Loading... Need help finding the right job? We can recommend jobs specifically for you!Click here to get started. Application FAQs Software Powered by iCIMS

Keywords: Jobleads, Bethesda , Clinical Advisor - NIH - TRP/DAIDS, Other , Bethesda, Maryland

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