Key Responsibilities and Required Skills for Xenotransplant Coordinator

🎯 Role Definition

The Xenotransplant Coordinator is the operational and clinical hub of an institutional xenotransplantation program. This role coordinates patient evaluation, donor animal procurement and handling, perioperative logistics, regulatory submissions (FDA, IRB, IACUC), infection control and surveillance, clinical data capture, and multidisciplinary team communication. The Coordinator ensures compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) as applicable, institutional biosafety, and program-specific SOPs while optimizing patient safety, organ viability, and study integrity.

Key SEO keywords: xenotransplant, xenotransplantation coordinator, porcine xenograft, xenotransplant program, clinical research coordinator, FDA IDE, IACUC, GCP, GMP, infection surveillance.

📈 Career Progression

Typical Career Path

Entry Point From:

Solid Organ Transplant Coordinator (heart, kidney, liver)
Clinical Research Coordinator (phase I–III)
Operating Room / Perioperative Nurse with transplant experience

Advancement To:

Senior Xenotransplant Program Manager
Director of Clinical Transplantation Innovation
Clinical Research Director — Transplantation Programs

Lateral Moves:

Tissue & Cellular Therapy Program Manager
Regulatory Affairs Specialist — Biologics/Devices
Clinical Trials Manager — Novel Therapeutics

Core Responsibilities

Primary Functions

Coordinate all aspects of xenotransplant clinical cases, including patient eligibility screening, informed consent processes, preoperative assessments, perioperative coordination, and post-transplant follow-up to ensure safety and protocol adherence.
Serve as the primary operational lead for xenotransplant procedures, orchestrating scheduling, operating room resources, surgical team assignments, and cold ischemia logistics to optimize graft viability.
Manage donor animal logistics and traceability: coordinate with veterinary partners, breeding facilities, and biomanufacture sites for procurement, transport, quarantine, and documentation of porcine donors or other donor species.
Maintain regulatory oversight and documentation for investigational xenotransplant programs, preparing and submitting IDE/IND support materials, FDA correspondence, IRB submissions, and responding to agency queries in partnership with regulatory affairs.
Coordinate Institutional Animal Care and Use Committee (IACUC) interactions related to donor animal use, ensuring compliance with animal welfare, quarantine, and biosecurity protocols.
Implement and monitor infection prevention and surveillance programs specific to xenotransplantation, including pre-transplant pathogen screening, post-transplant infectious disease monitoring, PERV testing strategies, and reporting of adverse events.
Develop, update, and enforce program-specific Standard Operating Procedures (SOPs), workflows, checklists, and emergency contingency plans related to xenotransplant operations, organ handling, and patient safety.
Oversee sample management and chain-of-custody for biologic specimens (tissue, blood, swabs) collected during xenotransplant studies; coordinate storage, transport, and shipment to central labs under appropriate cold chain and labeling requirements.
Lead cross-functional coordination between clinical teams, veterinary staff, cell/bioprocessing vendors, IRB, IACUC, microbiology labs, and regulatory partners to align timelines and ensure protocol compliance.
Manage informed consent and patient education specific to xenotransplantation, ensuring patients understand unique risks (zoonoses, immunologic considerations), follow-up schedules, and reporting obligations.
Track and report clinical metrics and quality indicators for the xenotransplant program, including graft function, patient outcomes, infection events, readmissions, and protocol deviations; prepare monthly and quarterly performance reports.
Serve as the primary point of contact for emergency responses related to xenotransplant patients (e.g., suspected zoonotic infections, unexpected graft failure), coordinating rapid multidisciplinary action and regulatory reporting.
Coordinate immunosuppression and adjunctive therapy protocols with transplant physicians and pharmacists, ensuring medication reconciliation, monitoring schedules, and adherence to study-specific regimens.
Maintain and audit complete study documentation (regulatory binder, source documents, eCRFs), ensuring GCP-compliant data quality, timely entry, and readiness for sponsor or regulatory inspections.
Train and supervise clinical research staff, nurses, and allied health personnel in xenotransplant-specific procedures, biosafety practices, specimen handling, and documentation requirements.
Oversee budgetary and resource planning for xenotransplant cases, including tracking procurement costs, vendor agreements, specialized disposables, and facility requirements for barrier or biocontainment spaces.
Coordinate quality assurance and continuous improvement initiatives, implementing corrective and preventive actions (CAPA) for process gaps discovered in audits, mock drills, or real cases.
Manage communication and consent for long-term patient registries and surveillance studies tied to xenotransplant recipients, ensuring data privacy (HIPAA) and long-term follow-up compliance.
Facilitate training and compliance for staff with biosafety level requirements, PPE protocols, and transport regulations for high-risk biologic materials tied to xenotransplant activities.
Collaborate with institutional legal and risk management teams to evaluate liability, indemnification, and contractual language for xenotransplant clinical trials, compassionate use, or expanded access cases.
Coordinate vendor and contract management for bioprocessing, pathogen screening assays, organ preservation technologies, and specialized equipment required for xenotransplantation procedures.

Secondary Functions

Support development of protocol amendments, SOP revisions, and training materials based on evolving regulatory guidance and scientific advances in xenotransplantation.
Participate in multidisciplinary case reviews, morbidity & mortality meetings, and ethics consultations to evaluate outcomes and inform program policy updates.
Assist with grant applications, industry partnerships, and investigator-initiated study coordination by providing operational feasibility, budget inputs, and recruitment strategies.
Maintain a searchable knowledge base and lessons-learned repository for xenotransplant cases to support continuous process optimization and institutional learning.
Coordinate mock drills and readiness assessments for xenotransplant scenarios, including simulated infection control breaches, organ transport failures, and emergency reoperation workflows.
Provide ad-hoc data extracts and support for outcomes analysis and registries, collaborating with biostatistics and data management teams to ensure accurate reporting.

Required Skills & Competencies

Hard Skills (Technical)

Clinical coordination of complex transplant procedures, including solid organ or xenotransplant cases.
Regulatory submission experience: FDA IDE/IND support, IRB application/maintenance, IACUC coordination.
Knowledge of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) as applicable, and clinical quality systems.
Biosafety and infection control expertise, including zoonotic risk mitigation and pathogen surveillance strategies (e.g., PERV screening).
Clinical data management: source documentation, eCRF entry, REDCap or sponsor EDC systems, and clinical registries.
Specimen chain-of-custody, cold chain logistics, and biorepository coordination.
Proficiency with medical record systems and clinical documentation (EPIC/Cerner or equivalent).
Project and program management skills: scheduling, resource allocation, vendor contracting, and budget tracking.
Surgical suite logistics and perioperative coordination, including OR scheduling and sterile processing interface.
Quality assurance skills: internal audits, CAPA management, SOP development, and inspection readiness.

Soft Skills

Clear, concise communicator who can convey complex scientific and regulatory information to clinicians, patients, and partners.
Strong organizational and time-management skills for high-stakes, time-sensitive coordination.
Leadership and team-building ability to align cross-disciplinary stakeholders (surgeons, veterinarians, lab scientists).
Problem-solving mindset, with the ability to make rapid, evidence-based decisions under pressure.
High emotional intelligence and patient-centered approach for managing consent and long-term follow-up complexities.
Attention to detail to ensure documentation, compliance, and patient safety in a regulated environment.
Adaptability and willingness to incorporate new scientific findings and regulatory changes into program operations.

Education & Experience

Educational Background

Minimum Education:

Bachelor’s degree in Nursing, Biology, Biomedical Sciences, Health Sciences, or related field. Equivalent clinical experience (e.g., RN) may substitute.

Preferred Education:

Bachelor of Science in Nursing (BSN) or Master’s degree in Clinical Research, Public Health, or related discipline.
Certifications such as CCRC/CCRP (SoCRA/ACRP), Certified Transplant Coordinator (CTC), or relevant regulatory training.

Relevant Fields of Study:

Nursing
Clinical Research / Clinical Trials Management
Biomedical Sciences / Microbiology / Immunology
Public Health / Health Administration

Experience Requirements

Typical Experience Range: 3–7 years clinical coordination experience with at least 2–3 years in transplant programs or complex clinical trials.

Preferred:

5+ years experience in solid organ transplant coordination, translational research programs, or xenotransplantation initiatives.
Direct experience managing regulatory submissions (FDA/IRB/IACUC), infection surveillance protocols, and multidisciplinary clinical teams.
Previous exposure to GMP/GCP environments, bioprocessing vendor coordination, and biosafety/biocontainment requirements.

If you would like, I can tailor this job description further to a specific institution (academic medical center, private hospital, or biotech sponsor) or produce a concise one-page posting optimized for applicant tracking systems (ATS).