Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Research Pharmacist with the National Institute of Allergy and Infectious Disease in Rockville, MD.
This is a long-term contract position which offers:
- Competitive compensation and comprehensive benefit package.
- Optional health, vision, and dental plans.
- Paid leave (min 120 hours) as well as 11 paid federal holidays and 401K plan.
- Access to NIH/NIAID’s unparalleled resources and niche scientific initiatives.
- Learn more about what Kelly can do for you at https://government.kellyservices.us/
TASKS. The contractor shall:
- 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.
- 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.
- 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.
- 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.
- 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.
REQUIREMENTS. The contractor must have:
- 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 APPLY ONLINE
When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.
Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren’t contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, short-term disability, and a transportation spending account. Visit https://www.mykelly.us/us-mykelly/perks/ for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
