Center Medical Director
4 weeks ago
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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