Kelly Services Research Pharmacist - Clinical Trials Advisor - NIH - Bethesda, MD in Bethesda, Maryland
Research Pharmacist – Clinical Trials Advisor * NIH * Bethesda, MD
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 – Clinical Trials Advisor to work on-site with the Office of Clinical Site Oversite within the National Institute of Allergy and Infectious Diseases in Bethesda, MD.
This is a long-term contract position which offers:
Competitive salary with comprehensive benefit package
Opportunity to work at NIH, world's foremost medical research center
Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com at http://www.kellygovernmentsolutions.com/
TASKS/SERVICES: The contractor shall:
(1) 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.
(2) 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.
(3) Ensure that pharmaceutical concerns raised during protocol reviews and implementation are addressed in a timely manner.
(4) Advise the protocol team regarding pharmaceutical issues relating to FDA regulations and in-country requirements.
(5) 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.
(6) Perform calculations for study product dilutions and aliquots and for compoundingpharmaceutical preparations.
(7) Provide pharmaceutical expertise during protocol conduct on pharmacy queries, productmanagement issues, product availability and appropriate recommendations.
(8) Review protocol and investigational brochure to take notes for characteristics of new protocols or updated information from revised protocols.
(9) Attend site initiation visits, site qualifying visits and protocol start-up meetings.
(10) Advice on implementing protocols with investigational drugs and drug accountability aspects that are critical for the investigator to be in compliance with applicable federal laws
(11) Prepare and implement pharmacy procedure set-up.
(12) Prepare investigational drug information and documents which provide specific guidelines how to handle and dispenses the investigational drug.
(13) Interact with physicians, nurses, outside sponsors, and other health professionals during the course of the clinical trial to make needed adjustments to procedures and specifications.
(14) Design computer screens used in protocol implementation.
(15) Serve as a point of contact for the given protocols and correspond with principal investigators, study coordinators and sponsors.
(16) Participate in the monitoring visit and answers any questions from auditor and monitor.
(17) Ensure that investigational drug supplies are obtained and maintained for all protocols under the proper storage condition and prepares documents for the temperature excursions.
(18) Control or coordinate physician authorization and access to investigational supplies.
(19) Direct technicians and others in carrying out responsibilities in support of clinical research such as ordering, auditing, transferring and returning investigational drugs to ensure the enough supply during the study.
(20) Attend and participate in U.S./Non- U.S scientific meetings/conferences and national meetings of professional societies and organizations.
(21) Review pharmacy monitoring assessment reports and provide input regarding pharmacy and protocol prioritization for Clinical Site Monitoring.
(22) Contribute and edit scientific papers reporting results of research protocols for publication in scientific journals.
REQUIREMENTS: The contractor must have:
(1) Doctor of Pharmacy (Pharm.D.) degree. Five (5) years of specialized experience plus Baccalaureate degree in Pharmacy (BS Pharmacy) is equivalent.
(2) Minimum of twelve (12) years of experience in a related field
(3) Licensed to practice pharmacy in a State, District of Columbia, or a territory of the United States.
(4) Excellent math skills to perform pharmaceutical calculations.
(5) Ability to work independently and as part of a team.
(6) Strong organizations skills.
(7) Excellent oral and written communication skills.
PLEASE APPLY ONLINE
Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted.
Once you have applied online to the position, if you have specific questions, you may contact us at email@example.com
AboutKelly Services ®
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