Clinical Laboratory, Clinical Pathology, Current Good Manufacturing Practice (cGMP), Data Analysis, EMT-Paramedics, FDA (Food and Drug Administration), Federal Compliance Regulations, Federal Laws and Regulations, Funding, Informed Consent, Licensed Practical Nurse/Licensed Vocational Nurse, Licensing, Maintain Compliance, OSHA, People Management, Performance Analysis, Physician Credential, Procedure Implementation, Regulations, Regulatory Compliance, Safety/Work Safety, Service Delivery, Standard Operating Procedures (SOP), Technical Consulting
JOB DESCRIPTION \u2013 Contracted Licensed Physician (Alternate)
ESSENTIAL JOB FUNCTIONS:
To provide independent medical judgment and discretion regarding donor safety, health, and suitability for plasmapheresis and/or immunization. The ideal candidate will demonstrate the ability to supervise medical staff and ensure compliance with federal and international regulations, as well as internal standard operating procedures. All duties assigned are required only when the primary Physician is unavailable, vacation, etc.
- Donor Interaction
- Ensure donor satisfaction through oversight of physician substitute (Medical Professionals; RN, LPN, EMT / Paramedic) interactions and responsiveness to donor needs.
- Select suitable plasmapheresis donors according to medical education, experience, and compliance with Standard Operating Procedures (SOP), FDA, OSHA, Clinical Laboratory Improvement Amendments (CLIA), and current Good Manufacturing Practices (cGMP), including informed consent administration and medical history assessment.
- Consultation Availability
- Provide on-site, telephone, or electronic consultation regarding donor eligibility, only when the primary is not available.
- Informed Consent Explanation
- Ensure detailed explanations of informed consents for plasmapheresis and immunization are provided to donors in compliance with applicable federal regulations.
- Donor Inquiry Response
- Supervise physician substitutes in addressing donor questions and ensuring that donors are given a clear opportunity to refuse participation.
- Physical Examinations
- Oversee the performance of physical examinations and analyze accumulated data to confirm established donor eligibility promptly.
- Medical Oversight
- Provide oversight to ensure that physician substitutes assess unusual or severe donor reactions with appropriate medical judgment.
- Training Requirements
- Deliver federal and internationally mandated training for donor center medical staff, including Physician Substitutes and Alternate Physicians. Management of Donor Reactions
- Exercise medical judgment to assess donor reactions and implement appropriate management procedures in line with current SOPs.
- Confidential Counseling
- Ensure that confidential counseling is provided to unacceptable donors, when applicable.
- Lab Result
- Review unusual or abnormal lab results, exercising independent judgment to determine future eligibility for donation. Service Delivery:
- Determine the method and means for the performance of contracted services in accordance with applicable
regulations and client requirements.
Education Specifications
- Must be a graduate from a licensed medical or osteopathic school.
- Must hold a current medical license in the state where the center operates.
- Must be approved by the state licensing agency as the alternate to the CLIA Laboratory Director, Clinical Consultant, and Technical Consultant for the donor center, as applicable.