Medical Director

1 week ago


Champaign, Illinois, United States CSL Plasma Full time
Job Summary

Clinical leadership is required for the Center Medical Director role at CSL Plasma. The successful candidate will provide medical oversight and direction to the center, ensuring compliance with regulatory requirements and maintaining high medical standards.

Key Responsibilities
  • Provide medical oversight and direction to the center, ensuring compliance with regulatory requirements and maintaining high medical standards.
  • Assure that CLIA/COLA training, CLIA/COLA proficiency testing for hematocrit and total protein, and signed of logs involving standardization takes place.
  • Review, understand, and comply with 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.
  • 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.
  • Evaluate newly trained Medical Staff Associates for completion of training and recommendation for certification by Regulatory Affairs.
  • Functionally direct the Center Medical Staff.
  • Provide training to other center staff on medically related procedures and practices.
  • Review and signed 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.
  • 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, which includes preparation of monthly reports and periodic conference calls.
  • Respond to questions and phone calls regarding donor suitability for long-term serial plasmapheresis.
  • Respond to calls from and provide instruction to Center Medical Staff with donor suitability questions.
  • Conduct confidential and effective interviews with donors to obtain information in a variety of situations.
  • Interview donors with positive STS/negative FTA and documents approval to resume donating.
  • Maintain confidentiality with respect to employee, donor and center records reviewed during the course of all duties.
  • Responsible for overseeing maintenance of medical supplies ad other emergency equipment.
  • Review and sings moderate and severe medical incident reports prior to donor being permitted to resume donating.
  • Reviews abnormal test results including abnormal serum protein electrophoresis (SPE) test results and donor record lc-PD-09195 Page 2 files.
  • Reviews normal SPE test results following an abnormal one and documents approval to resume donating.
  • Assure the health and safety of donors participating in the non-red blood cell immunization programs, if applicable.
  • Monitors donor clinical response to immunizations, when applicable.
  • Oversees hyper-immune programs, if applicable.
  • For red cell recipients in the Anti-D Program, if applicable:
    • Performs qualifying evaluation (e.g. administers consents, medical history and physical exam) on donors before enrollment;
    • Provides review and approval for red blood cell immunization;
    • Is present when red cell immunizations are given.
    • Submits monthly report to Divisional (or Corporate) Medical Director.
  • Determines donor suitability following adverse reactions in consultation with the Corporate or Divisional Medical Director.
  • Maintains current knowledge of infectious disease markets (i.e. HIV, HBV, HCV, syphilis, etc.).
  • 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, explaining informed consent materials to donors.
  • Performs additional services as and when requested by the company.
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.
  • One year of residency training as an MD or OD.
Equal Employment Opportunity

CSL is an equal opportunity employer and welcomes applications from diverse candidates. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications.


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