- Participate in the review, planning and implementation of clinical trials. This will include the evaluation of study design, feasibility, pharmaceutical regulatory requirements, and identifying solutions for pharmaceutical and logistical problems that may impede the conduct of a study.
- Develop the text for the study product section of the protocols in cooperation with members of the protocol team and the pharmaceutical manufacturers for existing pharmaceutical products as well as new chemical entities and modalities. This includes researching and analyzing background material from Investigator's Brochures, prescribing information, and literature reviews.
- Advise the study team and DAIT leadership regarding pharmacy aspects of proposed studies.
- Develop protocol specific training for site pharmacists and clinic staff utilizing web-based systems, software, or other tools (i.e., power point presentation).
- Provide leadership in collaboration with DAIT Project Managers and Regulatory Officers for developing study-specific blind labeling and packaging plan and strategies.
- Review and approve study-specific labels by DAIT CPC.
- Write and review Study Specific Pharmacy Manuals in collaboration with Project Managers.
- Ensure that pharmaceutical concerns raised during the DCRC and other meetings are addressed in a timely manner.
- Advise the protocol team regarding pharmaceutical issues relating to DAIT/NIAID standards, FDA and other Health Authorities regulations, State and in-country requirements.
- Evaluate the protocol and provide leadership with estimates of study product needs and or cost based on factors such as sample size, dose, formulation, strength, rate of accrual, and duration.
- Perform calculations for study product dilutions and aliquots and for compounding pharmaceutical preparations.
- Generate Study Product Request Letter/ Email for study-specific and division leadership's review and approval.
- Provide pharmaceutical expertise during protocol conduct on pharmacy queries, product management issues, product availability and appropriate recommendations.
- Conduct site visits as required to obtain information about existing infrastructure and processes to use to evaluate pharmacy personnel and infrastructure capacity at production facilities and Clinical Research Sites, as well as for-cause site visits as needed.
- Review Pharmacy Establishment Plans with the site Pharmacist of Record and DAIT Project Managers to obtain information and clarity needed for final review and approval.
- Evaluate and finalize all temperature excursions that occur during shipment and at Research Pharmacy Sites in collaboration with Regulatory Officers.
- Receive and process product complaints with or without AES/SAEs from research site pharmacies.
- Write/draft Standard Operating Procedures (SOPs) related to DAIT Pharmaceutical Services and participate in SOP review committees as needed.
- Assist DAIT/ NIAID Regulatory Officers in writing the Chemistry, Manufacturing, and Control (CMC) section of the Investigational-new drug (IND) application.
- Assist DAIT/ NIAID Clinical Product Center (CPC) Project Officer (PO)/ Contract Officer Representative (COR) in providing daily instructions, approvals for the CPC and other duties as needed for CPC oversight.
- Review and approve study-specific batch records submitted by DAIT CPC.
- Utilize pharmacy practice experience and pharmaceutical expertise in the design, review and revision of DAIT Pharmacy documents.
- Participate in DAIT/NIAID funded clinical network meetings, face-to-face protocol development meetings, and protocol team meetings as a pharmaceutical subject matter expert.
- Review pharmacy monitoring assessment reports and provide input regarding pharmacy and protocol prioritization for Clinical Site Monitoring plan as needed.
- Order, receive, ship to DAIT CPC and maintain chain of custody of Investigational Products (Ips) purchased by the DAIT Procurement Facility.
- Ensure proper storage conditions for IPs purchased by the procurement facility before they are transferred to DAIT CPC.
- Ensure orders received are properly reconciled in the FedMall in a timely fashion.
- Update the database of purchased IPs and track cost saving activities on a monthly basis.
- Doctor of Pharmacy degree (Pharm.D.) with accreditation as a registered pharmacist in one US state/jurisdiction 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.
- Minimum of one to three (1-3) years of Pharmacy residency and/or fellowship is preferred.
- Pharmacy board certification is preferred.
- Experience working in a quality-based environment is preferred.
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Clinical Advisor - Bethesda, United States - CAMRIS International, LLC
Description
OverviewWe are seeking a Clinical Advisor to support the National Institutes of Health's (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent, diverse and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate 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
Qualifications
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.
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.
