1. 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.
2. 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 of logs involving standardization takes place.
3. 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. Is physically present at the center for agreed upon hours.
4. Provides medical oversight to Medical Staff Associates, including their training, although such training may be delegated to an approved Medical Staff Associate. Trains other physicians. Evaluates newly trained Medical Staff Associates for completion of training and recommendation for certification by Regulatory Affairs. Functionally directs the Center Medical Staff. Provides training to other center staff on medically related procedures and practices.
5. Reviews and signed Medical Staff Associates notebooks weekly, including a review of approximately one out of five screening medical evaluations and unsuitable test result communications.
6. Meets with Medical Staff Associates at least once a month to discuss medically related topics. Documents each meeting. 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.
7. Responds to questions and phone calls regarding donor suitability for long-term serial plasmapheresis. Responds to calls from and provides 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.
8. Maintains 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.
9. Reviews 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
files. Reviews normal SPE test results following an abnormal one and documents approval to resume donating.
10. 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.
11. 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 beforeenrollment; 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.
12. 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.)
13. 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.
14. Performs additional services as and when requested by the company.
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
· Familiarity with Code of Federal Regulations (CFR) and all relevant procedures in the company Plasma Operating Procedures
(physical & mental requirements)
· Ability to make decisions which have significant impact on the department’s creditability, operations and services
· Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations
· Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens
· Required to wear Personal Protective Equipment while performing specific tasks or in certain areas
· Overnight travelrequired up to 75% of the time without lengthy lead-time