Clinical Pharmacy Advisor

Location
Rockville, Maryland
Posted
Oct 22, 2021
Ref
2021-10883
Hotbed
BioCapital
Required Education
Doctorate/PHD/MD
Position Type
Full time

We are currently searching for a Clinical Pharmacy Advisor t to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Rockville, MD.

 

Duties & Responsibilities
  • 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 and literature reviews.
  • Oversee and manage quality assurance standards and standard operating procedures for all pharmacy and product issues.
  • 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 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 program 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 the program to pharmaceutical companies
  • 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 topics, including protocols, study product 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, review and approve pharmacy plans required for the establishment of all clinical sites that participate in trials sponsored by NIH and other collaborators.
  • Review Pharmacy Establishment Plans which include 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 program documents.
  • Participate in NIH funded clinical network meetings, face-to-face protocol development meetings, and protocol team meetings as a pharmaceutical subject matter expert.
  • 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.

 

Requirements
  • Pharm.D. or B.S. degree from an accredited pharmacy school is required.
  • Licensed/registered as a pharmacist in a U.S. state or territory is required.
  • Completion of General Pharmacy Practice Residency or Specialized Residency or Fellowship plus one (1) year of clinical research experience or three (3) years of hospital pharmacy practice is required.
  • Knowledge or proficiency with the implementation or utilization of USP Guidance Chapters, 795>, <797>, and <800> is required.
  • Knowledge of Good Pharmacy Practice, Good Clinical Practice, and Human Subjects Protection is required.
  • 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.

      #LI-DD1

Due to our contractual requirements, to be eligible for this role, you must be fully vaccinated against COVID-19 at time of hire.  

Company Description

We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.

 

The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth. 

 

What you’ll get…

  • Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
  • Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
  • Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
  • Discovery! With our tuition assistance and training programs, we support your career advancement.
  • Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
  • Support! Working parents and busy professionals – we’ve got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
  • Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
  • A Voice! A unique culture where you can influence decisions and have your voice heard.

 

 

 

We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.