Sign In
 [New User? Sign Up]

Clinical Research Pharmacy Advisor

MSC


Location:
Bethesda, MD 20814
Date:
10/15/2020
2020-10-152020-11-14
Categories:
  • Healthcare
  • Biotechnology / Science
  • Government
MSC
  •  
  • Save Ad
  • Email Friend
  • Print

Job Details

Overview

Medical Science & Computing (MSC), a Dovel company, is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.

 

We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!

 

Duties & Responsibilities

MSC is searching for a Clinical Research Pharmacy Advisor 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 Bethesda, Maryland.

 

  • Develop and adhere to relevant SOPs and pharmacy manuals.
  • Review investigator brochures and conduct literature searches if needed to serve as subject matter expert regarding investigational products in ongoing research protocols.
  • Oversee training and mentoring of staff.
  • Manage the quality control, completion and submission of study related documentation.
  • Prepare, submit and maintain Institutional Review Board (IRB), FDA, and/or other regulatory documents and research correspondence as needed.
  • Monitor protocol compliance.
  • Perform clinical data interpretation and data entry as needed.
  • Answer questions regarding sterile compounding of investigational products.
  • Establish cold-chain plans for transportation and storage of investigational products.
  • Evaluate site pharmacies and give recommendations on their ability to meet protocol requirements for investigational product handling, storage, preparation, and dispensing.

Requirements

  • Pharm.D. or B.S. pharmacist (prior to 1992).
  • Licensed to practice pharmacy in one of the US States or Territories.
  • Completion of Good Clinical Practice (GCP) and Human Subjects Protection training and experience working in a GCP setting.
  • Experience with FDA 21 CFR 312 regulations.
  • Experience in a pharmacy practice setting working with sterile products and cold-chain of products.
  • Experience in clinical research setting with protocols and clinical trials.
  • Strong writing and recordkeeping skills.
  • Knowledge of the roles and responsibilities of an investigational drug research pharmacist.

 

Medical Science & Computing (MSC), a Dovel company, is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Powered ByLogo