Clinical Advisor
CAMRIS

Overview

We 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

• Coordinates and oversees study products supply, packaging, distribution, and accountability for all domestic and international clinical trials supported by the Division.
• Participates 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 study intervention 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.
• Oversees quality assurance standards and standard operating procedures for all pharmacy and product issues.
• Advises Branch management of merits and deficiencies in proposed studies.
• Assist with development of protocol specific training for site pharmacists and clinic staff utilizing web-based systems, software or other tools.
• Create and review Operations and Study Specific Procedures manuals with leadership.
• Ensure that pharmaceutical concerns raised during the Scientific Review Committee meetings and by the Regulatory Support Contract are addressed in a timely manner.
• Advise the protocol team regarding pharmaceutical issues relating to DAIDS standards, FDA regulations and in-country requirements.
• 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.
• Perform calculations for study product dilutions and aliquots and for compounding pharmaceutical preparations.
• Draft Study Product Request Letter for leadership review and final signature. These letters are the official letters of request from DAIDS to pharmaceutical companies.
• Provide pharmaceutical expertise during protocol conduct on pharmacy queries, product management issues, product availability and appropriate recommendations.
• Provide professional and technical assistance to pharmacists, study coordinators, investigators as well as domestic and international site personnel on a variety of topics, including protocols, study product preparation and dispensing information.
• Collaborate with protocol teams regarding communications and letters to site pharmacists during the entire conduct of a protocol.
• Conduct site visits to obtain information and create reports for federal staff to use to evaluate pharmacy personnel and infrastructure capacity at Clinical Research Sites.
• Establish standards for clinical site pharmacies, reviews and approves pharmacy plans required for the establishment of all clinical sites that participate in trials sponsored by DAIDS and other collaborators.
• Review Pharmacy Establishment Plans which include continuous communication with the site Pharmacist of Record to obtain information and clarity needed for final review and approval.
• Utilize pharmacy practice experience and pharmaceutical expertise in the review and revision of PAB and DAIDS documents.
• Participate in 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 (CSM).
• Contribute and edit scientific papers reporting results of research protocols for publication in scientific journals.
• Perform other assignments as required.

Qualifications

• Pharm.D. or B.S. degree from an accredited pharmacy school is required.
• Licensed/registered as a pharmacist in a U.S. state or territory.
• 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.
• Knowledge or proficiency with the implementation or utilization of USP Guidance Chapters (795), (797), and (800).
• Knowledge of Good Pharmacy Practice, Good Clinical Practice, and Human Subjects Protection.
• Excellent math skills in order to perform pharmaceutical calculations.
• Ability to work independently and display self-motivation in all aspects of work.
• Ability to function effectively and work diplomatically as part of a team.

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.

CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.

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.

This job has expired.