Job description
CSL Plasma Medical Director.
Responsibilities:
- Usually serves as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (FDA).
- Serves as the primary physician for reporting to the Food and Drug Administration and in such capacity provides medical oversight in compliance with applicable Federal and State regulations including the applicable sections of Title 21 of the Code of Federal Regulations and monitors medical compliance of the center.
- 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).
- Assures that CLIA/COLA training, CLIA/COLA proficiency testing for hematocrit and total protein, and signed logs involving standardization take place.
- Reviews understand and comply 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.
- Is physically present at the center for agreed-upon hours.
- Provides medical oversight to Medical Staff Associates, including their training, although such training may be delegated to an approved Medical Staff Associate.
- Evaluates newly trained Medical Staff Associates for completion of training and recommendation for certification by Regulatory Affairs.
- Functionally directs the Center's Medical Staff.
- Provides training to other center staff on medically related procedures and practices.
- Reviews and signs Medical Staff Associates notebooks weekly, including a review of approximately one out of five screening medical evaluations and unsuitable test result communication.
- Meets with Medical Staff Associates at least once a month to discuss medically related topics.
- Meets with the Center Manager and Compliance Specialist (or designees) during weekly visits to the center.
- Serves as a member of the Quality Assurance Team.
- Acts 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.
- Responds to questions and phone calls regarding donor suitability for long-term serial plasmapheresis.
- Responds to calls from and provide instruction to Center Medical Staff with donor suitability questions.
- Conducts confidential and effective interviews with donors to obtain information in a variety of situations.
- Interviews donors with positive STS/negative FTA and documents approval to resume donating.
- Maintains confidentiality with respect to employee, donor, and center records reviewed during the course of all duties.
- Responsible for overseeing the maintenance of medical supplies ad other emergency equipment.
- Reviews and sings moderate and severe medical incident reports prior to the 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.
- Assures 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.
- Determines donor suitability following adverse reactions in consultation with the Corporate or Divisional Medical Director.
- 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, and explaining informed consent materials to donors.
- Performs additional services as and when requested by the company.
Qualifications:
- 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.
Best Regards,
Kraig Shepard
480-664-4103
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