Contract Center Medical Director/Center Physician
Company: CSL Behring LTD
Location: Warwick
Posted on: August 3, 2022
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Job Description:
Job Description
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 donor's initial and continued
suitability for plasmapheresis, explaining informed consent
materials to donors.
14. Performs additional services as and when requested by the
company.
Education
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
Experience
* One year of residency training as an MD or OD
Additional Comments
* Familiarity with Code of Federal Regulations (CFR) and all
relevant procedures in the company Plasma Operating Procedures
Working Conditions
(physical & mental requirements)
* Ability to make decisions which have significant impact on the
department's 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.
CSL is introducing a new Career Framework, which will provide a
common, global infrastructure for managing jobs and serve as a
foundation for future career development and competitive rewards.
Certain components of this job description, including Title and
Level are subject to change relative to applicable local laws. Your
Talent Acquisition Consultant will discuss the pending changes with
you.
Please note, we may not have an immediate need at the present time;
however we are always interested in speaking to well qualified
candidates for future openings. If you are interested in exploring
a career with CSL, please apply. We may have both full-time and
part-time positions available. Someone will follow up depending on
the current needs, but please be aware correspondence may not be
immediate.
About Us
Our Benefits
We 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 Plasma
CSL 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 us
As a global organisation with employees in 35+ countries, CSL
embraces diversity, equity and inclusion. Learn more about
Diversity, Equity & Inclusion at CSL.
Do work that matters at CSL Plasma!
Keywords: CSL Behring LTD, Warwick , Contract Center Medical Director/Center Physician, Executive , Warwick, Rhode Island
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