Kelly Services
Location
Rockville, MD | United States
Job description
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 Clinical Advisor with the National Institutes of Health in Rockville, Maryland.
This is a long-term contract position which offers:
Competitive salary with comprehensive benefit package
Opportunity to work at NIH, the world's foremost medical research center
Learn more about what Kelly can do for you at
Scope:
Under this Task Order, the Contractor(s) shall provide services in support of the overall functions of the Pharmaceutical Affairs Branch, Office of Clinical Site Oversight, DAIDS .
Technical Requirements:
Clinical Advisor
• Coordinate and oversee study products supply, packaging, distribution and accountability for all domestic and international clinical trials supported by the Division.
• 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, literature reviews, or other technical data.
• Oversee and manage quality assurance standards and standard operating procedures for all pharmacy and study product issues.
• Advise Branch leadership 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 Division standards, FDA regulations and in-country requirements.
• Evaluate the protocol and provide Branch 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 Branch leadership’s review and final signature. These letters are the official letters of from the Division to pharmaceutical companies that describes the study product quantity estimates required for the implementation and completion of a clinical protocol. • 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 pharmacy and study product related topics, including study product management, handling, 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 the Division and other collaborators.
• Review Pharmacy Establishment Plans which includes continuous communication with the site Pharmacist to obtain information and clarity needed for final review and approval.
• Utilize pharmacy practice experience and pharmaceutical expertise in the review and revision of Branch and Division 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.
Specific Qualifications:
• Pharm.D. or B.S. Pharmacy 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.
• 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.
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.
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.
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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, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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