Center Medical Director

Center Medical Director

Requirements

• MD or DO degree from an accredited medical or osteopathic school.
• Must maintain a current and active medical license in the state in which the Center is located.
• If applicable for state regulations, must meet all state specific educational requirements.
• One year of residency training as an MD or OD.
• If applicable for state regulations, must meet all state specific experience requirements.

Responsibilities

• Serves as the primary physician for reporting to the Food and Drug Administration, providing medical oversight in compliance with applicable Federal and State regulations.
• Either serves as or delegates to another appropriate physician the duties of ‘laboratory director’, ‘technical consultant’, or ‘clinical consultant’ as prescribed by the Clinical Laboratory Improvement Act of 1988 regulations (CLIA).
• Reviews, understands, and complies with all CSL Plasma Services policies and procedures in the performance of services.
• Maintains high medical standards and ensures that cGMPs are adhered to through involvement with center management, center quality unit, and overall center activities.
• Provides medical oversight to Medical Staff Associates, including their training, although such training may be delegated to an approved Medical Staff Associate and observes MSAs periodically.
• Meets with Medical Staff Associates at least once a month to discuss medically related topics. Documents each meeting.
• May serve as a member of the Quality Assurance Team.
• Acts as a liaison between the Corporate or Divisional Medical Director and the Center Medical Staff.
• Responds to inquiries regarding donor suitability for plasmapheresis.
• Conducts confidential and effective interviews with donors to obtain information in a variety of situations.
• Maintains confidentiality with respect to employee, donor and center records reviewed during the course of all duties.
• Responsible for overseeing maintenance of medical supplies and other emergency equipment.
• Reviews and signs moderate and severe medical incident reports prior to donor being permitted to resume donating.
• Assures the health and safety of donors participating in the non-red blood cell immunization programs, if applicable.
• Determines donor suitability following donor adverse reactions (DAE).
• May 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.

Preferred Qualifications

• Familiarity with Code of Federal Regulations (CFR) and all relevant procedures in the company Plasma Operating Procedures.