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Director, Apheresis Site Operations

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About the Role:
The company is currently hiring a highly experienced Director to oversee the Apheresis clinic and nursing team at their Los Angeles, CA site. The ideal candidate will have current or prior strong clinical/leadership skills to support, motivate and educate the team. In this new role, you will be responsible to develop and execute the Leukopak business plan in alignment with the company's strategic plan. This role will have oversight of approximately 5 FTEs, and assist in the upcoming expansion of their donation centers to additional sites and states.

Prior experiences as a Registered Apheresis Nurse is required to direct and guide the team responsible for providing safe and effective patient care during the apheresis process. This includes assessing and monitoring patients, communications, performing apheresis procedures, and ensuring that the equipment and procedures used are in compliance with industry standards and regulations.

Primary Responsibilities:
Onsite Donor Center Leadership (Nursing and Operations staff)

Experienced leader and motivator of clinical and non-clinical staff including day to day supervision, employee relations and staff development.
Works with executive management and local site management at the site to identify and fulfill donor room staffing and subject recruitment needs to perform research studies in accordance with protocol requirements.
Drive departmental and operational strategies and plans, defining and executing on implementation plans for Leukopak collection and cryopreservation systems.
Create and execute project plans for collection center readiness.
Be an expert on the Leukopak and Cell Biology market.
Primary communications lead, communicating internally and externally in effective and timely ways.
Organize and coordinate Leukopaks collection and cryopreservation processes and training.
Responsible for day-to-day supervision of donor room staff including Registered Nurses and apheresis techs/ phlebotomists.
Problem solver with the ability to work collaboratively with medical staff and act as the go-between for the physician and the patient/donor.
Review all patient/donor information and product data.
Identify abnormal values and initiate follow up.
Document all patient care activities and capabilities to maintain change control processes and accurate records.
Educate patients and their families about the apheresis process and answer any questions they may have.
Communicate project status, deliverables, and risks to cross-functional teams.

Direct Onsite Donor Monitoring Procedures

Oversee the clinic to ensure that excellent patient care with optimal patient outcomes is provided and is of vital importance.
Provide 1-on-1 care to patient donors going through the Apheresis process.
Assess and monitor patients during apheresis procedures, including vital signs, fluid balance, and overall well-being. Recognize and treat reactions according to standard of care and under the direction of the Medical Director.
Ensure correct collection, packaging, cryopreservation, and storage of Leukopaks in accordance with FDA regulations.
Provide technical oversight and support for leukapheresis and cryopreservation.
Process donor blood specimens for analysis to include CBC, cell count and viability, etc. Provide training to staff on blood testing procedures.
Schedules donor room staff and coordinates with donor recruitment staff on scheduling of donors for pre screening activities and product collection schedules.
Serves as a resource to donor room staff related to technical aspects of blood product collection and compliance with protocols.
Monitor apheresis equipment and troubleshoot any issues that may arise.
Support activities related to cell product donations, processing, and storage.
Perform Apheresis procedures autonomously in freestanding outpatient centers.
Perform venipunctures, access central venous catheters, and access vortex and bard ports.
Responsible for communicating positive IDT results to participants.
Administer medications as needed during apheresis procedures.
Perform apheresis procedures using specialized equipment, including Amicus and Spectra Optia devices.
Participate in the development and implementation of policies and procedures related to apheresis nursing.
Identify and implement process improvements.

Safety, Regulatory & Compliance

Manage issues, risks, and recalls related to leukapheresis and cryopreservation.
Supporting activities related to procuring cell product donations, processing, and storage, including but not limited to, apheresis collection, labeling, sampling, storage and packing for shipping.
Maintain donor confidentiality and regulatory compliance.
Stay updated on industry standards and regulatory requirements.
Troubleshoot any building deficiencies needed to maintain compliance with regulatory bodies, Including the FDA.
Ensure that all procedures and equipment are in compliance with company standards and regulations.
Coordinate GxP training and support documentation management.
Perform cleaning, preventative maintenance and quality control on equipment according to standard operating procedures and manufacturer’s recommendations.
Maintain knowledge and techniques related to blood and apheresis collection.
Collaborate with other healthcare professionals, including the Medical Director, to monitor Adverse Events and provide emergency care, if needed
Record, document, and accurately report any adverse event that arise to Quality and the Medical Director

Position Requirements:

5+ years of extensive experience leading, managing and motivating teams of nurses/RNs at stand alone Apheresis donor center(s).
5+ years of donor apheresis or therapeutic apheresis experience.
Current California Medical/RN License and Basic Life Support CPR certification.
Maintains continuing education units (CEU) for nursing licensure
Extensive experience performing apheresis platelet, plasma & DRC procedures on Spectra Optia or Amicus devices
Prior nursing experience with research studies or clinical trials involving human subjects is preferred.
Familiar with current regulatory requirements and blood banking and HCT/P regulations and standards.
Excellent venipuncture & IV skills
Strong communication skills
Demonstrates exceptional professionalism and sense of responsibility and urgency at all times
Performs training or arranges for training of staff as needed.
Customer focused, with strong interpersonal skills, and the ability to build and maintain partnerships
Strong problem-solving capabilities, and the ability to prioritize effectively
Able to serve as a mentor and a resource to team members
Excellent Technology/Computer skills are a must (Google Suite, Microsoft Office products, including Word, Excel, Outlook, and PowerPoint).
Understanding confidentiality and privacy regulations when working with patients/donors
Ability to work independently with minimal supervision, and as part of a team
Basic computer skills, including electronic health records (EHR) and Microsoft Office
Background, Drug testing and state of CA immunization requirements for healthcare settings
Ability to work at the Los Angeles, CA at the company's apheresis donor site
Ability to work Monday - Thursday 7:00am - 5:30pm

Preferred

Bachelor's degree in nursing (BSN) preferred
Certification in apheresis nursing preferred

Salary Range:

$125,000 - $160,000/yr

The company is proud to provide equal employment opportunities to all qualified individuals without regard to race, color, religion, sex, gender identity, sexual orientation, pregnancy, age, national origin, physical or mental disability, military or veteran status, genetic information, or any other protected classification. Minorities, women, LGBTQ candidates, Veterans, and individuals with disabilities are encouraged to apply.