Clinical Advisor - Get Hired Fast

We are looking for a remarkable Clinical Advisor to join our high calibre team at CAMRIS International in Bethesda, MD.
Growing your career as a Full Time Clinical Advisor is an awesome opportunity to develop competitive skills.
If you are strong in critical thinking, project management and have the right mindset for the job, then apply for the position of Clinical Advisor at CAMRIS International today!

We are seeking a  Clinical Advisor to support the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) will provides support for a wide range of pharmaceutical activities, advisory and oversight for domestic and international NIAID/DAIT-sponsored/ funded clinical trials including but not limited to, review, planning, and implementation of clinical trials as well as coordination and overseeing of study product supply, packaging, distribution, and accountability to satisfy the overall operational objectives of the National Institute of Allergy and Infectious Diseases. Our NIAID professional, technical, and scientific support personnel are part of a team focused on positively impacting millions of lives around the world. Candidates will work at a diverse and vibrant NIAID worksite to directly support ongoing research activities as a contractor team member. Take the next big step in your career and apply below to help us make a difference.
CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.
Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad. 
Work closely with the Program Director and staff to serve as an authority in the use of pharmaceuticals in DAIT-supported clinical trials and related studies and provide expertise for pharmacy and pharmaceutical issues. Work with study teams (DAIT staff, principal investigators (PIs), clinical staff, and other researchers) to determine the appropriate strength and dosages of study product to be used in human clinical trials, assess and advise on dosages, toxicities, and any issues related to the proposed pharmaceuticals and biologicals to be used in a clinical trial; and recommend optimal dosing and dose escalation scales. Provide unblinded guidance to the unblinded site pharmacy staff about study product inventory, preparation and dispensing. In collaboration with DAIT investigators, develop and review the pharmacological section of the protocol and manual of operation for Phase I, Phase II, Phase III, and Phase IV trials. Participate in planning and implementation of study product manufacturing and distribution strategies for Phase I, II, III, and IV trials while ensuring compliance [Certified Good Manufacturing Practices (cGMP)], formulating proposals related to manufacturing methods, dosages, over[1]encapsulation, labeling, packaging, blinding, stability, storage, distribution methods, and related items. Participate in protocol team or clinical research site conference calls (as needed). Participate in the development and reviews of DAIT clinical trial agreements (CTAs) in conjunction with DAIT's Office of Regulatory Affairs to ensure that CTAs define and include protocol-specific study product management (e.g., blinding, packaging, randomization, distribution, etc.) while complying with all relevant federal regulations, policies, practices, and standard operating procedures. During the clinical trial, stay abreast of any problems or issues that arise related to the provision and/or characteristics of the pharmaceutical products (i.e., temperature excursions, recalls, complaints, etc.), work with pharmaceutical companies and sites to resolve any issues, and escalate issues to Senior CRPM staff as appropriate. Review reports regarding pharmaceutical issues and concerns from clinical trials in progress, including analysis of pharmacological data, advising investigators on the revision of dosing schedules, assessing the effects of pharmacological agents, reviewing and advising on related issues that affect the assessment of the clinical trial's results, and revising procedures in subsequent phases of the trial as necessary; and escalates issues to Senior CRPM staff as appropriate. Review monitoring reports and work with sites and monitor to develop action plan(s) as part of performing quality assurance activities regarding all clinical site pharmacies to ensure compliance with national and international regulations and to ensure patient safety. Provide oversight of DAIT clinical site pharmacies and reviews Pharmacy Establishment Plans, including establishment of standards and approval of pharmacy plans for new pharmacies or clinic-based pharmacies; and maintain continued liaison with clinical site pharmacy staff. Assess the pharmacy infrastructure of research centers, networks, and clinical trial sites and, as necessary, advise investigators on any issues, including any needed modifications or corrections that are identified. Provide professional and technical assistance to clinical site pharmacists, study coordinators, monitors, and investigators at both domestic and international sites, including providing information on protocols, study product preparation, and dispensing information. Manage a portfolio of study products for assigned protocols, including the forecasting, acquisition, and inventory management for all investigational new drug (IND) agents distributed to DAIT sponsored clinical trials, and ensuring accountability in the government ordering system databases. Approve protocol-specific inventory management such as: Ordering site study product request, study product procurement, inventory management and tracking, Creating and updating spreadsheet(s), Returning unused study products to the federal government drug distributor for potential cost credit, and (v) creating reports for external stakeholders, e.g., DAIT/NIAID OD, the Biomedical Advanced Research and Development Authority (BARDA), etc. Coordinate the provision and distribution of study products to the DAIT CPC, clinical sites, or research organization(s) conducting the clinical trials. Serve as a back-up to prepare and document the study product chain of custody (transfer and receipts) in appropriate physical binders and electronic folders. Serve as a back-up point of contact correspond with the pharmaceutical companies and the government-contracted drug distributor to facilitate the procurement of study products for use in DAIT- supported clinical trials. Serve as a back-up to physically receive and inspect study products and maintain chain of custody. Assist the senior Pharmacist in mentoring and providing guidance and training on tasks performed by the pharmaceutical program coordinator, students, and other staff. Serve as a back-up to document and maintain equipment maintenance logs on a periodic basis. Remain abreast of current information on all applicable U.S. and international regulations regarding product labeling, packaging, distribution, accountability, and maintaining of chain of custody while ensuring compliance with applicable regulations by DAIT clinical trials groups and other collaborators. Review and approve study-specific documentation related to manufacturing batch records, labeling, packaging, distribution plans, product returns and destructions, and temperature excursions. Provide approvals for study product purchases for assigned protocols. Perform site visits or audits, evaluating facilities, equipment, pharmacy personnel, and infrastructure capacity and assist with the creation of the report(s) detailing the visit (as needed). Remain abreast of current developments in pharmacology and provides pharmaceutical expertise, guidance, and training pertaining to pharmacy issues related to DAIT-supported clinical trials, and provide assessments of pharmaceutical procedures, practices, and operating protocols used in NIAID/DAIT-supported clinical trials. Serve as an advisor and consultant on pharmacological matters with program officials and staff throughout NIAID/DAIT, in other organizational components of NIAID, and in outside research organizations. Create and review NIAID/DAIT's current pharmaceutical policies, standard protocols, practices, and procedures for clinical trials, as well as Standard Operating Procedures (SOP), and recommend improvements, modifications, or corrections. Serve as a member of Branch and Office level working groups, as needed. Doctor of Pharmacy degree (Pharm.D.) or B.S. degree from an accredited pharmacy school with accreditation as a registered pharmacist in a US state/jurisdiction is required. Completion of General Pharmacy Practice Residency or Specialized Residency or Fellowship plus 1 year of clinical research experience or 3 years of hospital pharmacy practice is required. Experience in investigational drug management, clinical research, protocol development and conduct, regulatory affairs (e.g., GMP manufacturing, IND filing, adverse events) and/or allergy or infectious diseases practice is required. Proficiency in MS Office including Word, Excel, Outlook, and PowerPoint is required. Experience and proficiency in effective communication orally and in writing is required. Excellent analytical, organizational and time management skills are required. Master of Health Sciences (or similar degree) in clinical research, regulatory or public health (or similar) is preferred. Pharmacy board certification is preferred. Experience working in a quality-based environment is preferred. CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law. Full vaccination against COVID-19, defined as two doses of Moderna, two doses of Pfizer, or one dose of Johnson & Johnson's Janssen, is required for this position. Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding. Benefits of working as a Clinical Advisor in Bethesda, MD:
? Excellent benefits
? Opportunities to grow
? Advantageous package