CSL Plasma Inc. | Contract Center Medical Director/Center Physician
hace 3 días
Apply locations Americas, US-RI, East Providence 202, CSL Plasma time type Full time posted on Posted 30+ Days Ago job requisition id R-064118
- Serves as the primary physician for reporting to the Food and Drug Administration and provides medical oversight in compliance with applicable Federal and State regulations, including 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 takes place.
- 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.
- 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 recommends certification by Regulatory Affairs. Functionally directs the Center Medical Staff and 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 communications.
- 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, including preparation of monthly reports and periodic conference calls.
- Responds to questions and phone calls regarding donor suitability for long-term serial plasmapheresis. Provides instruction to Center Medical Staff with donor suitability questions. Conducts confidential and effective interviews with donors to obtain information in various 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. Reviews abnormal test results and donor record files. Reviews normal test results following an abnormal one and documents approval to resume donating.
- Assures the health and safety of donors participating in 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, and explaining informed consent materials to donors.
- 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.
ExperienceOne year of residency training as an MD or DO.
Additional CommentsFamiliarity with Code of Federal Regulations (CFR) and all relevant procedures in the company Plasma Operating Procedures.
Working ConditionsAbility to make decisions that have significant impact on the department’s credibility, 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 bloodborne pathogens. Required to wear Personal Protective Equipment while performing specific tasks or in certain areas. Overnight travel required up to 75% of the time without lengthy lead-time. Frequent standing and walking in a fast-paced environment with frequent interruptions.
Note: 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.
Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma.
We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Plasma #J-18808-Ljbffr-
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