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 the leading medical research center in the world. We are seeking an experienced individual to work as a Clinical Advisor (Clinical Trials) at the National Institutes of Health in Rockville, MD.
This is a long-term contract position which offers:
- Competitive compensation and comprehensive benefit package
- Optional health, vision, and dental plans
- Vacation leave as well as 10 paid federal holidays and 401K plan.
Access to NIH’s unparalleled resources and niche scientific initiatives
TASKS/SERVICES. The contractor shall:
- 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 and literature reviews.
- Advise Branch management 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 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.
- Generate 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.
- 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.
- Review Pharmacy Establishment Plans which includes 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.
- 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.
- Perform other assignments as required.
REQUIREMENTS. The contractor must have:
- Pharm.D. or B.S. 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.
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.
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