Job Summary
Job Description
To provide independent medical judgment and discretion for donor safety, health, and suitability for plasmapheresis and/or immunization. Provide federal and international mandated training and donor center medical staff supervision to ensure compliance with applicable laws in medically related areas.
Job Responsibilities
2. Select suitable plasmapheresis donors pursuant to the PHYSICIAN’s medical education and experience and in accordance with Standard Operating Procedures (SOP,) the Food and Drug Administration (FDA,) Occupational Safety and Health Administration (OSHA,) Clinical Laboratory Improvement Amendments (CLIA,) Current Good Manufacturing Practice (cGMP) by utilizing informed consent administration, assessing medical history and administering physical examinations.
3. Be accessible to provide on-site, telephone, or electronic consultation regarding donor eligibility.
4. Explain informed consents for plasmapheresis and immunization to donors based upon the physician’s judgment and discretion and in compliance with 21 CFR 630.5 and 21 CFR 630.15 including but not limited to explanation of the plasmapheresis procedure, hazards, potential adverse reactions, and specific immunization programs, if applicable.
5. Answer and discuss any donor questions and ensure the donor is given a clear opportunity to refuse participation.
6. Perform physical examinations for donors based upon the PHYSICIAN’s medical training and experience and exercise medical judgment when analyzing accumulated data, which must be reviewed in a timely manner to confirm established donor eligibility.
7. Provide appropriate level of care and medical judgment when assessing issues related to unusual or severe donor reactions.
8. Provide federal and international mandated training for donor center medical personnel including, Physician Substitutes and Alternate Physicians.
9. Exercise medical judgment by assessing donor reactions to institute appropriate management procedures in accordance with current Standard Operating Procedures (SOPs).
10. Provide appropriate and confidential counseling to unacceptable donors, if applicable.
11. Review unusual or abnormal lab results and exercise independent judgment to determine donor’s future eligibility for donation.
12. Consistent with applicable federal and international regulations and company clients’ requirements, Physician shall determine the method and means for the performance of the contracted services.
Qualifications
2. PHYSICIAN must be currently licensed in the state in which the center operates.
3. PHYSICIAN must be approved by the state licensing agency as the CLIA Laboratory Director, CLIA Clinical Consultant and CLIA Technical Consultant for the donor center, as applicable.
4. All PHYSICIAN qualifications enumerated within the Agreement, including but not limited to the requirements contained in Article 3 “Representations of PHYSICIAN,” Article 5 “Conflicts of Interest,” and Article 13 “Professional Liability Insurance.”
Working Hours
Skills
Clinical
Blood Banking