Reporting to the Corporate Medical Director, the Corporate Medical Specialist will support the US Plasma Procurement Medical Department. This includes the review of donor adverse events, management of donor claims, management of physician vendor setup and invoicing, assessment of the medical operations at the door centers, tracking and trending of parameters and audit results, and delivering training and development programs for the center medical staff as needed.
PRIMARY RESPONSIBILITIES
- Be readily familiar with Current Good Manufacturing Practices (cGMP) training, current State and Federal guidelines, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), cGMP and pertinent sections of the CFR
- Know and understand company procedures and pertinent regulations that relate to all aspects the medical department at the donor center level
- Maintain certification and proficiency in all the functions of the Center Medical Specialist at the donor center and serve as a designed trainer as needed for all donor center platforms of the Grifols Plasma Operations
- Maintain certification and proficiency in the company specialty programs and conduct training, assessment and corrective plans at donor centers, as requested.
- Maintains current medical licensure, and capable of obtaining medical licensing in multiple states as requested by CMO.
- Development and design of training materials for the center medical staff. These can be computer based training, web based modules or paper manuals.
- Provides training to all levels of center staff thru teleconferencing and/or hands on training.
- Conduct onsite visits to donor centers to assist the Divisional Teams on quality improvement processes and implementation of corrective action plan with the center medical staff.
- Evaluate some donor incident reports generated at the donor center to assess for sound medical management and proper documentation
- As requested, maintains database of all donor adverse events, including data entry, of all the reports related to these events in the organization.
- As requested, create and maintain database for specific information pertinent to the medical operations
- Capable of completing basic statistical analysis of data collected, and generate reports for the Chief Medical Officer
- Reviews, prepares and analyzes medical data and information from internal resources and provide executive reports as requested.
- Assist the Chief Medical Officer with Corporate training programs, education materials and quality improvement projects for the medical department and in the editing and review of medical procedures for the Standard Operating Procedure (SOP) and the Medical Reference Manual
- Creates documentation such as data dictionaries, test plans, database interpretations and database requirements for SOP.
- Promote customer satisfaction through appropriate interaction and responsiveness to customer needs.
- Conduct activities in a responsible and ethical manner according to accepted medical standards to ensure donor safety and product safety.
- Conduct activities in accordance with Grifols’ history, values and mission to ensure donor safety and product safety.
- Prepares project specific documentation to reflect methods used with details to support comprehension and replication of the analysis.
- May collaborate as instructor of the Grifols Academy of Plasmapheresis
- Recommend changes and improvements to the Standard Operating Procedures
- Assists the department as needed with other duties as assigned.
EDUCATION & EXPERIENCE
- Have an active and unrestricted license as a Registered Nurse (RN) with a Bachelor of Science in Nursing (BSN), Master of Science in Nursing (MSN) or Doctor of Nursing Practice (DNP). Maintain current CPR certification.
- Typically five years of experience
KNOWLEDGE, SKILLS AND ABILITIES
Knowledge of current SOPs for all Grifols donor center Platforms, cGMP, Federal and State regulations as they relate to biologics. Excellent oral and written communication skills. Excellent interpersonal skills. Strong organization skills. Strong quantitative and analytical skills, critical thinking and problem-solving skills. Ability to analyze and interpret data, identify errors and prepare reports. Ability to relate and interact with a diverse population with heterogeneous social and educational backgrounds. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to train or obtain consensus on issues. Knowledge of medical terminology and plasma center procedures. Proficient of computer programs such as Office, Excel, Power Point and Word. Knowledge of Access program desirable.
OCCUPATIONAL DEMANDS
Must be willing to travel, sometimes for prolonged periods of time. Occupational Demands Form # 9: Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with frequent travel within the United States.
EEO Minorities/Females/Disability/Veterans