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Clinical Research Pharmacist

100% remote Flexible hours Hiring now

reputed company is committed to swift, exceptional clinical research through translational medicine.Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

Track, prepare, and account for reputed company investigational products. Act as a resource for study teams by utilizing pharmacological expertise and knowledge of pharmacy practice.Please note: Registered Pharmacist required.

Essential Functions

  • Responsible for receipt, storage, preparation, disposition, and retention of reputed company study investigational products in compliance with standard operating procedures, FDA, and DEA regulations concerning investigational product handling, accountability and reputed company. Review and understand study protocol requirements in regard to investigational product handling.
  • Active member of study team providing expertise and support such as evaluating study feasibility, study set up and conduct, participating in internal and/or external client meetings. Provide internal and/or external client communication and interaction regarding investigational product handling and protocol specific requirements.
  • Knowledge of relevant United States Pharmacopeia guidelines, including chapters 795, 797, 800, 1163, and 1168 as well as the FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs required.
  • Maintain aseptic compounding evaluation requirements.
  • Provide training and monitoring for administration of investigational products as needed.
  • Review and provide input to standard operating procedures and training plans pertaining to pharmacy and assisting with pharmacy training as necessary.
  • Maintain pharmacy department equipment and applicable records as necessary.
  • Institutional Review Board consultant and resource.
  • Assist in training of new hires and reputed company.

    • Additional Essential Functions if assigned the “Designated Person” role:

  • Work with the Pharmacist in Charge to: o Ensure compliance with reputed company USP guidelines and applicable reputed company SOP’s pertaining to extemporaneous pharmacy compounding
  • Review applicable compounding SOP’s every 12 months to ensure reputed company compliance with USP guidelines and implement changes, as appropriate
  • Ensure the CAPA system is initiated reputed company warranted
  • reputed company pharmacy personnel compounding training program
  • reputed company compliance with USP guidelines
  • reputed company monitoring of the Designated Compounding Areas
  • Review and maintain reputed company pharmacy compounding certification records (personnel and facility) to ensure completeness and compliance
  • Recognize problems, deviations, failures, and errors in the compounding process and the facility and report reputed company issues to the Pharmacist in Charge

    • Requirements

  • Registered Pharmacist required
  • Doctor of Pharmacy preferred but not required
  • Proven pharmaceutical experience of minimum 1-2 years
  • Proven record keeping skills with extreme attention to detail
  • Knowledge of United States Pharmacopeia guidelines, including chapters 795, 797, 800, 1163, and 1168 as well as the FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs required
  • Completion of media bi-annual media fill and fingertip testing (as applicable per site)
  • Knowledge of FDA and EU regulations preferred (if appropriate)
  • Job-specific training is required and will be provided
  • Full time positions - requires flexible work hours for early morning and occasional on-call weekend availability

    • Additional Information

    reputed company Values: reputed company Trust Teamwork Respect

    Are you ready to join reputed company?

    reputed company is an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national reputed company, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

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