Clinical Advisor Jobs

We are seeking a Clinical Advisor to support the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. 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.

• Collaborate with protocol teams regarding communications and letters to site pharmacies during the entire conduct of a protocol.
• Perform site visits and assessments and CRO evaluation and monitoring required by the Sponsor.
• Review QA/QC reports on temperature monitoring, inventory, dispensing, chain of custody, and pharmacy staff training completion and documentation.
• Advise site research pharmacies and study team with relevant operational and regulatory guidance to ensure safe and accurate dispensing and management of study drugs during the clinical trials.
• Lead the planning, review, and implementation of all pharmacy and study drug aspects of VRC sponsored clinical trials at external sites.
  • Evaluate study design, feasibility, pharmaceutical regulatory requirements, and identify solutions for pharmaceutical and logistical problems that may impede the conduct of a study.
  • Develop the study product section of the protocol in cooperation with members of the protocol team, project management, and manufacturing team for existing pharmaceutical products as well as new chemical entities and modalities.
  • Evaluate site Pharmacy Establishment Plans for the qualification to conduct clinical trials.
  • Develop strategies for maintaining adequate pharmacy space/facilities for ongoing and projected clinical research studies.
  • Develop and lead protocol-specific and pharmacy-related trainings for site pharmacists, clinic staff, and clinical monitoring vendors utilizing web-based systems, software, or other tools.
• Develop the study product section of the protocol in cooperation with members of the protocol team, project management, and manufacturing team for existing pharmaceutical products as well as new chemical entities and modalities.
• Recommend and contribute to process improvement or changes needed from audit findings or Sponsor oversight activities.
• Function as pharmacy liaison for studies conducted in the VRC Vaccine Evaluation Clinic and for external site pharmacies when VRC-sponsored studies are conducted at external sites.
  • Work with pharmacy management (i.e.: IDCU/IVAU for studies conducted at the NIH Clinical Center) and quality control/assurance team to ensure ongoing compliance.
  • Provide collaborative support to VRC research pharmacy staff on research protocols, processes, and techniques.
  • Advise site research pharmacies and study team with relevant operational and regulatory guidance to ensure safe and accurate dispensing and management of study drugs during the clinical trials.
• Advise and develop the mechanism for drug quality tracking and documentation with relevant players in VRC including project management team and vaccine manufacturing team.
• Assess impact of local, regional, and global requirements and considerations on drug labeling and utilization.
• Create templates, SOPs and/or work instructions related to PDI processes.
• Evaluate the protocol and provide estimates of study product needs based on factors such as sample size, dose, formulation, strength, rate of accrual, and duration.
• Lead Pharmacy Dispensing Instructions (PDI) processes.
  • Facilitate communication between CTP, Vaccine Production Program (VPP), and Pharmacy for the timely creation of PDIs.
  • Lead the monthly and ad hoc PDI working group meetings.
  • Meet deadlines by closely communicating with study coordinators, IND managers, and PDI working group.
  • Review documents relevant to the content of PDI, such as, protocol, IB(s), in-use stability reports, and Sponsor correspondence.
  • Create templates, SOPs and/or work instructions related to PDI processes.
  • Maintain version control of PDIs with updates upon additional in-use stability data.
  • In collaboration with VRC pharmacist and formulation group, triage product related questions from internal and external collaborators on the preparation and storage of investigational products.
• Provide input on research pharmacy operation and SOPs.
• Identify, troubleshoot, and resolve deficiencies.
• Identify the local requirements by national regulators in conducting multi-national clinical trials in study drug utilization.
• In collaboration with VRC pharmacist and formulation group, triage product related questions from internal and external collaborators on the preparation and storage of investigational products.
• Develop and lead protocol-specific and pharmacy-related trainings for site pharmacists, clinic staff, and clinical monitoring vendors utilizing web-based systems, software, or other tools.
• Serve as an investigational pharmacy expert for VRC CTP Oversight Monitoring Team (OMT) activities for all VRC-sponsored studies.
  • Provide input on research pharmacy operation and SOPs.
  • Identify, troubleshoot, and resolve deficiencies.
  • Serve as primary reviewer for pharmacy management plans, monitoring and audit reports.
  • Serve as primary author for Corrective and Preventive Action Plans for pharmacy issues, and work with sites to resolve significant issues.
  • Perform site visits and assessments and CRO evaluation and monitoring required by the Sponsor.
  • Contribute pharmacy-related content as it pertains to the creation and revision of OM monitoring plans, work instruction, tracking form and templates.
• Analyze and interpret research data.
  • Contribute to and edit scientific papers and abstracts reporting results of research protocols for publication in scientific journals, scientific presentations, and communications as appropriate.
  • Perform other related problem solving and assignments as required.
• Serve as primary reviewer for pharmacy management plans, monitoring and audit reports.
• Contribute to and edit scientific papers and abstracts reporting results of research protocols for publication in scientific journals, scientific presentations, and communications as appropriate.
• Routine and ad hoc review of pharmacy policy and procedures.
• Communicate with Regulatory Science and Strategy Program (RSSP) team to evaluate the regulatory outcomes of initial product concepts or a similar product category and make recommendations for future actions.
• Research and review background material from Investigator's Brochures, prescribing information, and literature reviews.
• Advise the ACDU and CTP Leadership of study drug related regulatory changes and guidance established by FDA and local authorities.
  • Evaluate the regulatory environment and provide internal advice throughout the life cycle of the product (e.g., concept, development, manufacturing, utilization, recall, product quality assessment) to ensure compliance.
  • Identify the local requirements by national regulators in conducting multi-national clinical trials in study drug utilization.
  • Communicate with Regulatory Science and Strategy Program (RSSP) team to evaluate the regulatory outcomes of initial product concepts or a similar product category and make recommendations for future actions.
  • Assess impact of local, regional, and global requirements and considerations on drug labeling and utilization.
• Evaluate the regulatory environment and provide internal advice throughout the life cycle of the product (e.g., concept, development, manufacturing, utilization, recall, product quality assessment) to ensure compliance.
• Advise on the pharmaceutical process during VRC-sponsored external clinical trials.
  • Research and review background material from Investigator's Brochures, prescribing information, and literature reviews.
  • Evaluate the protocol and provide estimates of study product needs based on factors such as sample size, dose, formulation, strength, rate of accrual, and duration.
  • Review and advise the initial formulation and labeling of the study drug to be utilized in the clinical trials.
  • Write and/or review SOPs and Manual of Procedures (MOP).
  • Collaborate with protocol teams regarding communications and letters to site pharmacies during the entire conduct of a protocol.
• Work with pharmacy management (i.e.: IDCU/IVAU for studies conducted at the NIH Clinical Center) and quality control/assurance team to ensure ongoing compliance.
• Review protocols and ensure the accuracy in study configuration in Argus Database.
• Contribute to training of VRC pharmacy technicians.
• Evaluate study design, feasibility, pharmaceutical regulatory requirements, and identify solutions for pharmaceutical and logistical problems that may impede the conduct of a study.
• Evaluate site Pharmacy Establishment Plans for the qualification to conduct clinical trials.
• Maintain version control of PDIs with updates upon additional in-use stability data.
• Review and identify issues with data entry and interpretation in terms of study drug regimen, route, and administration in open and blinded trials.
• Perform other related problem solving and assignments as required.
• Meet deadlines by closely communicating with study coordinators, IND managers, and PDI working group.
• Serve as primary author for Corrective and Preventive Action Plans for pharmacy issues, and work with sites to resolve significant issues.
• Review NIH Clinical Center Pharmacy's policies and procedures to ensure Sponsor requirements are met.
  • Recommend and contribute to process improvement or changes needed from audit findings or Sponsor oversight activities.
  • Review QA/QC reports on temperature monitoring, inventory, dispensing, chain of custody, and pharmacy staff training completion and documentation.
  • Investigate incidents of non-compliance and contribute to resolution.
  • Review pharmacy created documents such as memos and Notes to File for accuracy and completeness, distribution and filing of completed documents to relevant internal study team members and storage location.
  • Routine and ad hoc review of pharmacy policy and procedures.
  • Contribute to training of VRC pharmacy technicians.
    
• Develop strategies for maintaining adequate pharmacy space/facilities for ongoing and projected clinical research studies.
• Provide collaborative support to VRC research pharmacy staff on research protocols, processes, and techniques.
• Lead the monthly and ad hoc PDI working group meetings.
• Serve as a pharmaceutical expert for VRC Pharmacovigilance team.
  • Review protocols and ensure the accuracy in study configuration in Argus Database.
  • Review and identify issues with data entry and interpretation in terms of study drug regimen, route, and administration in open and blinded trials.
  • Advise and develop the mechanism for drug quality tracking and documentation with relevant players in VRC including project management team and vaccine manufacturing team.
• Facilitate communication between CTP, Vaccine Production Program (VPP), and Pharmacy for the timely creation of PDIs.
• Review pharmacy created documents such as memos and Notes to File for accuracy and completeness, distribution and filing of completed documents to relevant internal study team members and storage location.
• Review and advise the initial formulation and labeling of the study drug to be utilized in the clinical trials.
• Investigate incidents of non-compliance and contribute to resolution.
• Write and/or review SOPs and Manual of Procedures (MOP).
• Contribute pharmacy-related content as it pertains to the creation and revision of OM monitoring plans, work instruction, tracking form and templates.
• Review documents relevant to the content of PDI, such as, protocol, IB(s), in-use stability reports, and Sponsor correspondence.

• Excellent computer and database skills, familiarity with ARGUS platform is preferred.
• Must take initiative and have ability to work independently and as a team member, offering assistance wherever needed.
• Experience with MedDRA and drug coding reviews.
• Knowledge of clinical trial, drug safety and PV methodologies including safety profile and risk/benefit analysis; detailed comprehension of global regulatory requirements in PV is a plus.
• Strong attention to detail and follow-up skills is required.
• Ph.D. in a scientific field. Three (3) years of specialized experience plus a master's degree is equivalent to a Ph.D. Five (5) years of specialized experience plus a BA/BS degree is equivalent to a Ph.D.
• Must be proactive and able to create contingency plans to deal with possible challenges and roadblocks.
• Strong background in clinical trial drug safety is required.
• Must be flexible and willing to take on administrative responsibilities to support the PV team, including drafting meeting agendas and note taking, filing documents, scheduling meetings, sending and tracking requests and reminders to collaborators for data collection.
• An understanding of medical terminology and ability to summarize medical information is required.
• Experience in the conduct and management of clinical trials, phase I - III vaccine or monoclonal antibody clinical trials preferred.
• Eight (8) years of experience in a science related field.
• Certified RAC-Drug credential preferred.

CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at www.CAMRIS.com. 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.

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.

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.