8 days old

Clinical Research Pharmacist/Advisor (Hybrid Work) - NIH

Kelly Services
Rockville, MD 20851
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 experienced individuals to work as a Clinical Research Pharmacist/Advisor at the National Institutes of Health in Rockville, MD. Hybrid work arrangement available.

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 paid federal holidays and 401K plan.

- Access to NIHs unparalleled resources and niche scientific initiatives

TASKS/SERVICES. The contractor shall:

(1) Provide support to the Pharmaceutical and Investigational Pharmacy services within the Division of Allergy, Immunology, and Transplantation (DAIT) in the National Institute of Allergy and Infectious Diseases (NIAID)

(2) Participate in the review, planning and implementation of clinical trials including evaluation of study design, feasibility, pharmaceutical regulatory requirements, costs, and identifying solutions for pharmaceutical and logistical problems that may impede the conduct of a study.

(3) 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. This includes researching and analyzing background material from Investigators Brochures, prescribing information, and literature reviews.

(4) Develop protocol specific trainings for site pharmacists and clinic staff utilizing web-based systems, software, or other tools

(5) Provide leadership in collaboration with DAIT Project Managers and Regulatory Officers for developing, reviewing, and approving study-specific blind labeling and packaging plan and strategies.

(6) Write and review Study Specific Pharmacy Manuals in collaboration with Project Managers.

(7) Advise the protocol team regarding pharmaceutical issues relating to DAIT/NIAID standards, FDA and other Health Authorities regulations, State and in-country requirements.

(8) Perform calculations for study product dilutions and aliquots and for compounding pharmaceutical preparations.

(9) Provide pharmaceutical expertise during protocol conduct on pharmacy queries, product management issues, product availability and appropriate recommendations.

(10) Conduct site visits as required to obtain information about existing infrastructure and processes to use to evaluate pharmacy personnel and infrastructure capacity at production facilities and clinical research sites as well as for-cause site visits as needed.

(11) Review Pharmacy Establishment Plans with the site Pharmacist of Record and DAIT Project Managers to obtain information and clarity needed for final review and approval.

(12) Receive and process product complaints with or without AES/SAEs from research site pharmacies.

(13) Assist DAIT/ NIAID Regulatory Officers in writing the Chemistry, Manufacturing, and Control (CMC) section of the Investigational-new drug (IND) application and standard operating procedures (SOPs)

(14) Review pharmacy monitoring assessment reports and provide input regarding pharmacy and protocol prioritization for Clinical Site Monitoring plan as needed.

(15) Order, receive, ship to DAIT Clinical Product Center, store, and maintain chain of custody of Investigational Products (Ips) purchased by the DAIT Procurement Facility.

REQUIREMENTS. The contractor must have:

(1) Doctor of Pharmacy (Pharm.D.) degree with accreditation as a registered pharmacist in one US state/jurisdiction

(2) Minimum of one to three (1-3) years of pharmacy residency and/or fellowship preferred

(3) Pharmacy board certification preferred

(4) Additional degree (MS or Ph.D.) or training in clinical research, regulatory affairs, public health, related discipline preferred

(5) Experience in investigational drug management, clinical research, protocol development and conduct, regulatory affairs (e.g., GMP manufacturing, IND filing, adverse events), and/or allergy or infectious diseases practice

(6) Experience working in a quality-based environment preferred

Please Note: Vaccination against COVID-19 is a requirement for all job opportunities offered through Kelly Government Solutions, in accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.


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 arent 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 a specialty talent company, Kelly is committed to doing the right thing for our talent and clients. We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise. With a focus on safety, value, well-being, investment, and opportunity, Kellys Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover whats next.

It is obvious things are different than they were just a few months ago. Kelly is at the forefront of ensuring the safety of our employees in this new working environment. Be well and stay strong.

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **?**

Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. Its just another way we make the job search work for you.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity Equal Employment Opportunity is The Law. (


Posted: 2022-06-17 Expires: 2022-07-18

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Clinical Research Pharmacist/Advisor (Hybrid Work) - NIH

Kelly Services
Rockville, MD 20851

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast