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27 days old

Senior Clinical Advisor - NIH - Rockville, MD

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 an experienced individual to work as a Senior Clinical Advisor 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 NIHs 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 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.

+ Advise the study team and DAIT leadership regarding pharmacy aspects of proposed studies.

+ Develop protocol specific trainings for site pharmacists and clinic staff utilizing web-based systems, software, or other tools (ie., power point presentation).

+ Provide leadership in collaboration with DAIT Project Managers and Regulatory Officers for developing study-specific blind labeling and packaging plan and strategies.

+ Review and approve study-specific labels by DAIT CPC.

+ Write and review Study Specific Pharmacy Manuals in collaboration with Project Managers.

+ Ensure that pharmaceutical concerns raised during the DCRC and other meetings are addressed in a timely manner.

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

+ Evaluate the protocol and provide leadership with estimates of study product needs and or cost 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/ Email for study-specific and division leaderships review and approval.


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

+ 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.

+ 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.

+ Evaluate and finalize all temperature excursions that occur during shipment and at Research Pharmacy Sites in collaboration with Regulatory Officers.

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

+ Write/draft Standard Operating Procedures (SOPs) related to DAIT Pharmaceutical Services and participate in SOP review committees as needed.

+ Assist DAIT/ NIAID Regulatory Officers in writing the Chemistry, Manufacturing, and Control (CMC) section of the Investigational-new drug (IND) application.

+ Assist DAIT/ NIAID Clinical Product Center (CPC) Project Officer (PO)/ Contract Officer Representative (COR) in providing daily instructions, approvals for the CPC and other duties as needed for CPC oversight.

+ Review and approve study-specific batch records submitted by DAIT CPC.

+ Utilize pharmacy practice experience and pharmaceutical expertise in the design, review and revision of DAIT Pharmacy documents.

+ Participate in DAIT/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 as required.

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

+ Order, receive, ship to DAIT CPC and maintain chain of custody of Investigational Products (Ips) purchased by the DAIT Procurement Facility.

+ Ensure proper storage conditions for IPs purchased by the procurement facility before they are transferred to DAIT CPC.

+ Ensure orders received are properly reconciled in the FedMall in a timely fashion.

+ Update the database of purchased IPs and track cost saving activities on a monthly basis.


REQUIREMENTS. The contractor must have:


+ Doctor of Pharmacy degree (Pharm.D.) with accreditation as a registered pharmacist in one US state/juristication is required.


+ Experience in clinical research, protocol development and conduct, regulatory affairs (e.g., GMP manufacturing, IND filing, adverse events) and/or allergy or infectious diseses practice is required.

+ Minimum of one to three (1-3) years of Pharmacy residency and/or fellowship is preferred.

+ Pharmacy board certification is preferred.

+ Minimum of ten (10) years of related experience. Examples of desired experience include investigational drug related experience, serving on an Institutional Review Board, drug manufacturing experience, or clinical trial management experience.

+ Experience and proficient in communicating effectively orally and in writing.

+ Excellent analytical, organizational and time management skills.

+ Expertise in MS Office including; Word, Excel, Outlook, and PowerPoint.

+ Experience working in a quality-based environment.


**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.


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.


**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** ****


Kelly connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. Were always thinking about whats next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 500,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice.


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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-03-26 Expires: 2021-04-26

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Senior Clinical Advisor - NIH - Rockville, MD

Kelly Services
Rockville, MD 20851

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