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Provides medical oversight to Medical Staff Associates, including the training of other physicians and Medical Staff Associates. Usually serves as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (FDA).
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 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.
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 donors 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 departments 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 travel required up to 75% of the time without lengthy lead-time
Frequent standing and walking
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.
Worker Type:Contingent Worker
Worker Sub Type:Contingent Worker Staff Augmentation
Posted 30+ Days Ago
With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSLs therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
If you are an individual with a disability and need a reasonable accommodation for any part of the
CSL does not accept referrals from employment businesses and/or employment agencies with respect to the vacancies posted on this site. All employment businesses/agencies are required to contact CSL's human resources department to obtain prior written authorization before referring any candidates to CSL. The obtaining of prior written authorization from the human resources department is a condition precedent to any agreement (verbal or written) between the employment business/ agency and CSL. In the absence of such written authorization being obtained, any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of CSL. CSL shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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