Donor Services Coordinator
This position is a key member of the Aziyo Biologics team and as such is responsible for the timely and accurate compilation and technical review of donor medical records to ensure regulatory compliance. The candidate will support continuous improvements within the organization while ensuring adherence to applicable regulatory and accreditation requirements and actively foster an organizational culture that is based upon collaboration, partnership, innovation, customer service, driving change, and teamwork.
Position reports to Manager, Donor Services
Essential Duties & Responsibilities
- Compiles and maintains all donor records and reviews to ensure that all records are in compliance with regulatory agencies as appropriate, (i.e., AATB, FDA, state agencies, etc.)
- Performs technical review of donor recovery and medical charts for accuracy, completeness, and consistency
- Reviews donor chart information for completeness and accuracy and ensures donor is in compliance with SOPs and applicable standards/regulations
- Prepares and reviews donor chart information for submission to the Medical Director for final determination of donor eligibility
- Extracts information from hospital records and determines the donor suitability as it relates to various product specifications
- Works to apply changing processor and industry standard criteria to the donor chart review process
- Works closely with other departments and customers to provide and obtain information for product release
- Knowledge of customer criteria to specify donor suitability and allow for processing of donors for the correct products in a timely manner
- Distributes information to other procurement agencies and processing centers as appropriate.
- Maintains documentation of in-process tissue as required, updating records at each step in the process.
- Maintains confidentiality of donor related information.
- Accepts referral calls from recovery agencies and advises on applicability of Aziyo’s Donor Eligibility Criteria and accepts or defers donors for recovery
High School Diploma or equivalent required. B.S. in Life Science related field or equivalent work experience required
Experience and Skills
- Minimum of two years of experience in a regulated industry or in a clinical or hospital setting required
- Knowledge of diseases and medical terminology is required
- Medical Background (EMT, Lab Technologist, Nurse, Paramedic, Medical Transcriptionist, Eye Bank/Tissue Bank Industry) preferred
- Experience with hospital/medical records is required
- Experience in a FDA-regulated environment, with knowledge of 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products (HTC/P) preferred
- Ability to understand and design policies and procedures based on FDA, AATB, and OSHA regulations
- Triage Call Availability
- Advanced PC, database and Microsoft Office skills
- Willingness to obtain his/her Certified Tissue Bank Specialist certification within two years of date of hire
- Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.)
- Excellent verbal and written communication skills
- Ability to juggle multiple tasks and prioritize work appropriately with a focus on timelines and deliverables
- Ability to drive results through partnership, mutual respect and trust