Center Medical Director

4 weeks ago


Indianapolis, Indiana, United States CSL Plasma Full time
Job Description

As a Center Medical Director at CSL Plasma, you will provide medical oversight to Medical Staff Associates, ensuring the highest standards of care and compliance with regulatory requirements.

Key Responsibilities:

  • Provide medical training and oversight to Medical Staff Associates, including training on medical procedures and protocols.
  • Serve as the primary physician for reporting to the Food and Drug Administration (FDA) and ensure compliance with applicable Federal and State regulations.
  • Delegate duties to other physicians as prescribed by the Clinical Laboratory Improvement Act of 1988 regulations (CLIA).
  • Assure that CLIA/COLA training, CLIA/COLA proficiency testing, and signed logs involving standardization take place.
  • Review and understand all CSL Plasma Services policies and procedures in the performance of services.
  • Maintain high medical standards and ensure that cGMPs are adhered to through involvement with center management, center quality unit, and overall center activities.
  • Be physically present at the center for agreed-upon hours.
  • Provide medical oversight to Medical Staff Associates, including their training, although such training may be delegated to an approved Medical Staff Associate.
  • Train other physicians and evaluate newly trained Medical Staff Associates for completion of training and recommendation for certification by Regulatory Affairs.
  • Functionally direct the Center Medical Staff and provide training to other center staff on medically related procedures and practices.
  • Review and sign Medical Staff Associates notebooks weekly, including a review of approximately one out of five screening medical evaluations and unsuitable test result communication.
  • Meet with Medical Staff Associates at least once a month to discuss medically related topics and document each meeting.
  • Meet with the Center Manager and Compliance Specialist (or designees) during weekly visits to the center.
  • Serve as a member of the Quality Assurance Team.
  • Act as a liaison between the Corporate or Divisional Medical Director and the Center Medical Staff, including preparation of monthly reports and periodic conference calls.
  • Respond to questions and phone calls regarding donor suitability for long-term serial plasmapheresis.
  • Conduct confidential and effective interviews with donors to obtain information in a variety of situations.
  • Interview donors with positive STS/negative FTA and document approval to resume donating.
  • Maintain confidentiality with respect to employee, donor, and center records reviewed during the course of all duties.
  • Be responsible for overseeing maintenance of medical supplies and other emergency equipment.
  • Review and sign moderate and severe medical incident reports prior to donor being permitted to resume donating.
  • Review abnormal test results, including abnormal serum protein electrophoresis (SPE) test results, and donor record files.
  • Review normal SPE test results following an abnormal one and document approval to resume donating.
  • Assure the health and safety of donors participating in the non-red blood cell immunization programs, if applicable.
  • Monitor donor clinical response to immunizations, when applicable.
  • Oversee hyper-immune programs, if applicable.
  • Determine donor suitability following adverse reactions in consultation with the Corporate or Divisional Medical Director.
  • Maintain current knowledge of infectious disease markets (i.e. HIV, HBV, HCV, syphilis, etc.).
  • Perform Center Physician functions, including but not limited to notifying donors of unsuitable test results, performing screening medical evaluations, assessing results of donor screening and laboratory tests to determine a donor's initial and continued suitability for plasmapheresis, explaining informed consent materials to donors.
  • Perform additional services as and when requested by the company.

Requirements:

  • MD or DO degree from an accredited medical or osteopathic school.
  • Maintain a current and active medical license in the state in which the Center is located.
  • One year of residency training as an MD or OD.

Benefits:

  • Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage.
  • Company-provided basic life insurance and Short- and Long-Term Disability.
  • The option to participate in CSL's 401(k) Savings Program.
  • Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business.
  • Paid observed holidays as designated by the Company.


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