Position Objective: Provide services as a Clinical Advisor in support of the overall functions of the Pharmaceutical Affairs Branch, Office of Clinical Site Oversight, DAIDS within the National Institute of Allergy and Infectious Diseases. Duties and 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 trainings 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’s 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.
Basic 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.
Minimum Qualifications:
Ability to communicate effectively, orally and in writing, with non-technical and technical staff.
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.
Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.
GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.
This position is contingent upon contract award.
Requisition ID: 7202