Under minimal supervision, this position is responsible for overseeing the daily operations of the center to ensure research orders are being fulfilled. This position is responsible for performing all duties related to the efficient, safe and compliant collection of research and clinical apheresis blood products. Works collaboratively as a lead member of the team and in alignment with the values of the organization. Performs Apheresis Red Cell, Plasma and Plateletpheresis on FDA approved devices... more details
Under minimal supervision, this position is responsible for overseeing the daily operations of the center to ensure research orders are being fulfilled. This position is responsible for performing all duties related to the efficient, safe and compliant collection of research and clinical apheresis blood products. Works collaboratively as a lead member of the team and in alignment with the values of the organization. Performs Apheresis Red Cell, Plasma and Plateletpheresis on FDA approved devices as well as test devices for research. Performs patient and research MNC and PBMC Collections. Participates in Clinical trials with approved IRB protocols.
DUTIES AND RESPONSIBILITIES:
- Performs subject screening of research collections, phlebotomy, packing/shipping, daily quality control, manual and electronic record completion.
- Participates in research studies. Obtains consent, enrolls and educates subjects, administers research questionnaires. Completes CRF documentation and inputs data for clinical trial and protocol enrollment documentation.
- Maintains proficiency and certification for all tasks required by the position (for example Human Research Subjects, Good Clinical Practices (GCP) and Good Tissue Practices (GTP), NMDP confidentiality training, CPR, etc.
- Communicates all pertinent information effectively and timely. Brings issues to management and/or medical director, as necessary.
- Works as part of a team to achieve daily/weekly order fulfillment to meet client expectations.
- Maintains complete and accurate records, including subject and patient files.
- Performs apheresis procedures on multiple apheresis platforms, (ex. Trima, Amicus, Haemonetics PCS2, Spectra Optia, etc). Manage multiple versions of equipment software. Problem solve any device deficiency / equipment issues and report per SOPs
- Performs special collections (ex. Dendreon, NMDP, research leukopheresis, granulocytes, etc.) on patients / research subjects / donors.
- Assists with recruitment of research subjects, pre-screening and scheduling of research subjects to fulfill research orders / requests.
- Perform chart review, notify supervisor of any errors.
- Maintain daily operations of department and efficient workflow of departmental tasks.
- Manage Cell Sourcing client requests and order fulfillment (ex. Residual product requests).
- Manage Supply inventory, technical and administrative supplies needed to perform specialty tasks of the department. Review package inserts of all incoming supplies and updates in document system as needed.
- Manage equipment (ex. validations, actions in equipment software database, coordinates preventative maintenance).
- Advanced user in BECs (Blood Establishment Computer System).
Knowledge/ Education
High School Graduate or GED required.
Bachelors Degree preferred.
Licenses/Certifications
Current CPR Certification required.
Experience
One year of previous work experience in a healthcare related field required.
One year of previous work experience in research required.
Phlebotomy experience required.
Two years of previous work experience in a healthcare related field preferred.
Skills/Abilities
Demonstrated leadership and good communication skilled.
Possess the skills and abilities to successfully perform all assigned duties and responsibilities.
Able to maintain subject, donor, patient and employee confidentiality.
Effective oral and written communication skills.
Proficient computer skills specifically with Windows operating systems.
Able to read and comprehend written procedures and instructions.
Excellent customer service and interpersonal skills.
Ability to work in a team environment and participate as a lead team member.
Legible handwriting.
Able to work flexible shifts and holidays, as needed.
Physical ability to lift, bend and/or reach.
Ability to travel, as required.