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Clinical Advisor - NIH - TRP/DAIDS

Company: Regional Recreation Corporation of Wood Buffalo
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/DAIDSJob Locations US-MD-Bethesda # of Openings 1 Category NIAID Type Regular Full-TimeOverviewCAMRIS 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).ResponsibilitiesWorks with Branch Chief, Physicians, and Program Officers to:Review, participate in design/development, and oversee implementation of clinical trials for thetreatment and/or prevention of TB and TB/HIV co-infection.o Evaluate the hypothesis, objectives, study design, feasibility, and regulatoryrequirements, as well as identifying medical and logistical problems that may impede astudy.o Participate in clinical trial team discussion on selection and implementation ofinterventions, study design, evaluation of clinical events and endpoints, safetyassessments, and assurance of participant safety.o Interact with investigators, statisticians, other DAIDS components and supportcontractors, product sponsors, and other agencies engaged in assigned research activitiesand related fields.o Review, assure necessary revisions, and approve drafts of trial protocol, informedconsent, and important implementation documents (e.g., the Study Progress and SafetyMonitoring Plan).o Provide subject matter expertise during protocol development leading to Program reviewand decision whether to approve, and ensure that the concerns raised during the revieware addressed by the Protocol Development Team in a timely manner to allow finalapprovals.Monitor progress and conduct of projects, including protection and safety of participants inclinical trials. The incumbent reviews data, progress reports, and reports of events of criticaldeviations from protocol or regulations, and implements corrective actions needed to achieveadequate research. Advises program management of deficiencies and problems encounteredduring study implementation.Evaluate annual IND annual reports for implementation issues and medical safety and reportfindings 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' leadershipto ensure trials are conducted according to protocol, regulations and accepted standards.Provide clinical and scientific information for preparing NIAID communications to the Food andDrug Administration (FDA), other government and nongovernmental agencies, pharmaceuticalcompanies. and Data Safety Monitoring Boards.Preview, revise as needed, and approve safety reports (IND and MedWatch to FDA and/or safetyalerts or communications for investigators), provides expert medical advice for potential impactof adverse events in ongoing research.Produce documents, presentations, and responses to requests for information as required inplanning and implementation of the clinical trials agenda.Liaison with other NIH ICs and other sponsors to ensure coordination, avoid unnecessaryduplication, and to participate in collaborative efforts being conducted nationally andinternationallyAttends and participates in national/international scientific meetings/conferences in order to stayabreast of current research findings and to interact with other investigators to promotecollaborations.QualificationsRN degree and active license, PA or NP certification strongly preferredor 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 positionare consistent with those identified as the minimum requirements for the labor categoriesspecified in the contract.OptionsApply for this job online Apply Share Refer this job to a friend Refer Sorry the Share function is not working properly at this moment. 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Keywords: Regional Recreation Corporation of Wood Buffalo, Bethesda , Clinical Advisor - NIH - TRP/DAIDS, Other , Bethesda, Maryland

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