What are the responsibilities and job description for the Center Medical Director position at CSL Plasma?
Job Description
The primary physician will serve as the main point of contact for the Food and Drug Administration (FDA) and be responsible for providing medical oversight in accordance with federal and state regulations. This includes monitoring medical compliance at the center.
Key Responsibilities:
- Either serve as or delegate to another physician the duties of "laboratory director", "technical consultant", or "clinical consultant" as prescribed by CLIA regulations.
- Ensure that all necessary training and testing take place, including CLIA/COLA training and proficiency testing for hematocrit and total protein.
- Review and comply with all CSL Plasma Services policies and procedures.
- Maintain high medical standards and ensure adherence to cGMPs through involvement with center management and quality unit.
Additional Duties:
- Provide medical oversight to Medical Staff Associates, including their training.
- Train other physicians and evaluate newly trained Medical Staff Associates for certification by Regulatory Affairs.
- Functionally direct the Center Medical Staff and provide training on medically related procedures and practices.
- Review and sign Medical Staff Associates notebooks weekly.
Liaison and Reporting:
- Meet with the Center Manager and Compliance Specialist during weekly visits to discuss center activities.
- Serve as a member of the Quality Assurance Team and act as a liaison between the Corporate or Divisional Medical Director and the Center Medical Staff.
- Prepare monthly reports and participate in periodic conference calls.
Confidentiality and Safety:
- Maintain confidentiality regarding employee, donor, and center records.
- Oversee the maintenance of medical supplies and emergency equipment.
Adverse Reactions:
- Determine donor suitability following adverse reactions in consultation with the Corporate or Divisional Medical Director.
Education and Experience:
- MD or DO degree from an accredited medical or osteopathic school.
- One year of residency training as an MD or DO.
