Address
Form of workJob Description
Responsibilities
- Coordinate and oversee study products supply, packaging, distribution and accountability for all domestic and international clinical trials supported by the Division.
- 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 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, literature reviews, or other technical data.
- Oversee and manage quality assurance standards and standard operating procedures for all pharmacy and study product issues.
- Advise Branch leadership of merits and deficiencies in proposed studies.
- Develop protocol specific trainings for site pharmacists and clinic staff utilizing web based systems, software or other tools.
- Write and review Operations and Study Specific Procedures manuals.
- 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 Division standards, FDA regulations and in-country requirements.
- Evaluate the protocol and provide Branch 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.
- Generate Study Product Request Letter for Branch leadership's review and final signature. These letters are the official letters of from the Division to pharmaceutical companies that describes the study product quantity estimates required for the implementation and completion of a clinical protocol.
- 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 pharmacy and study product related topics, including study product management, handling, 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 the Division and other collaborators.
- Review Pharmacy Establishment Plans which includes continuous communication with the site Pharmacist to obtain information and clarity needed for final review and approval.
- Utilize pharmacy practice experience and pharmaceutical expertise in the review and revision of Branch and Division documents.
- Participate in NIAID funded clinical network meetings, face-to-face protocol development meetings, and protocol team meetings as a pharmaceutical subject matter expert.
- Attend and participate in U.S./Non-U.S scientific meetings/conferences and national meetings of professional societies and organizations.
- 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.
- Pharm.D. or B.S. Pharmacy degree from an accredited pharmacy school.
- 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.
