Job opening ID
Roles and responsibilities
Must be a US Citizen
Some travel may be required
Columbus Technologies and Services Inc. is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Columbus 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 Clinical Advisor to work onsite with the National Institutes of Health in Rockville, MD.
This is a long-term contract position which offers:
- Competitive salary
- Tremendous growth opportunity
- Opportunity to work at NIH, the world's foremost medical research center
- Learn more about what Columbus can do for you at www.columbususa.com
•Participate in the review, planning and implementation of clinical trials; evaluate study design, feasibility, and pharmaceutical regulatory requirements; identify solutions for pharmaceutical and logistical problems that may impede the conduct of a study.
•Develop the text for the study product 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; research and analyze background material from Investigator’s Brochures; prescribe 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 Clinical Sciences 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.
•Teach pharmacy techniques/procedures to other pharmacists, pharmacy residents, fellows, interns, or students.
•Doctor of Pharmacy (Pharm.D.) degree. Five (5) years of specialized experience plus Baccalaureate degree in Pharmacy (BS Pharmacy) is equivalent.
•Licensed to practice pharmacy in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.
•Completion of General Pharmacy Practice Residency or Specialized Residency or 1 year clinical trial research experience or 3 years of hospital pharmacy/clinical pharmacy practice experience. Board certified Pharmacotherapy Specialist (BCPS) or Oncology Pharmacist (BCOP) preferred.
•Investigational drug service (IDS) or investigational pharmacy experience.
•Experience providing inpatient pharmacy services and preparing the complete range of sterile products (parenteral, enteral, and parenteral nutrition, and intravenous additives for a large medical facility).
•Experience in compounding drugs as prescribed, including IV and chemotherapy drugs.
•Excellent math skills to perform pharmaceutical calculations.
•Ability to work independently and as part of a team.
•Strong organizations skills.
•Excellent oral and written communication skills.
Number of positions