Clinical Advisor

Overview

We are seeking a Clinical Advisor to support the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) in the Clinical Trials Program. 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.

Responsibilities

• Lead the planning, review, and implementation of all pharmacy and study drug aspects of VRC sponsored clinical trials at external and international 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 protocols 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 the 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.
• Advise management of scientific merits and pharmaceutical process during clinical trials.
  • Identify deficiencies in study design or methodology during protocol development and recommend solutions where needed.
  • Research and review background material from Investigator’s Brochures, prescribing information, and literature reviews.
  • Evaluate the protocol and provide leadership with 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 review Operations and Study Specific Procedures manuals.
  • Collaborate with protocol teams regarding communications and letters to site pharmacies during the entire conduct of a protocol.
• Function as pharmacy liaison for NIH Clinical Center Pharmacy for VEC studies and external site pharmacies for multinational studies.
  • Work with pharmacy management and quality control/assurance team to ensure ongoing compliance.
  • Provide support and mentoring for 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.
• As a certified RAC-Drug professional, advise the team 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 Office of Regulatory Science 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.
• Serve as an investigational pharmacy expert for VRC CTP oversight monitoring team activities.
  • 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.
• 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.
• 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.
  • Attend and participate in U.S./Non-U.S. scientific meetings/conferences and national meetings of professional societies and organizations.
  • Attend and participate in regulatory meetings/workshops organized by FDA, EMA, and RAPS to stay compliant and current with changes in regulatory requirements.
  • Perform other related problem solving and assignments as required.
• Lead the implementation of Pharmacy Dispensing Instructions (PDI) processes.
  • Establish internal working group and communication platforms between CTP, 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 correspondences.
  • Maintain version control of PDIs with updates upon additional in-use stability data.
  • Work with key internal stakeholders including VRC leadership, Regulatory Science and Strategy Program (RSSP), Vaccine Pilot Plant (VPP), and other relevant parties to establish the workflow and roles and responsibilities.
  • Triage product related questions from internal and external collaborators in terms of preparation and storage in a timely fashion.
  • Distribute PDIs to relevant parties for internal and external studies for ongoing and completed studies.
• Ensure NIH Clinical Center Pharmacy’s policy and procedures are incompliance with requirements by local regulation and the Sponsor.
  • Recommend and contribute to process improvement or changes needed from audit findings or Sponsor oversight.
  • Review and improve QA/QC reports on temperature monitoring, inventory, dispensing, chain of custody, and pharmacy staff training completion and documentation.
  • Investigate incidences or non-compliances 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.
  • Training and coaching of VRC pharmacist and technician.
• Interact with IDCU/IVAU managers and Pharmacy QC/QA team.
• Serve as an investigational pharmacy expert for VRC CTP oversight monitoring team activities.
  • 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 to the creation and revision of OM monitoring plans, work instruction, tracking form and templates.
• 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.

Qualifications

• 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.
• Eight (8) years of experience in a science related field. Demonstrates expert knowledge working in the research laboratory environment. Computer skills to include MS Office Suite.

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.

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.

MD

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