Key Responsibilities and Required Skills for Xenotransplant Research Coordinator

🎯 Role Definition

We are seeking an experienced Xenotransplant Research Coordinator to manage and operationalize preclinical and clinical xenotransplantation studies. The coordinator will act as the central point of contact across surgical teams, veterinarians, laboratory scientists, regulatory affairs, and external vendors to ensure studies are executed to protocol, within regulatory frameworks (IACUC, IRB, FDA), and aligned with GMP/GLP requirements. This role requires strong project management, detailed regulatory documentation, specimen and data stewardship, and the ability to translate scientific objectives into safe, compliant operational plans. Keywords: xenotransplantation, xenograft, clinical research, preclinical studies, IACUC, IRB, GMP, GLP, biosafety, transplant surgery, xenotransplant research coordinator.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Coordinator (CRC) with experience in transplantation or immunology.
Animal Research Technician / Veterinary Research Assistant familiar with IACUC-regulated work.
Research Assistant or Lab Manager in transplant or immunology labs.

Advancement To:

Senior Xenotransplant Research Coordinator / Study Manager.
Clinical Trials Manager or Program Manager for transplantation research.
Regulatory Affairs Manager or Director of Translational Research.

Lateral Moves:

Quality Assurance Specialist (GMP/GLP focus).
Clinical Project Manager for surgical or device trials.

Core Responsibilities

Primary Functions

Serve as the operational lead for xenotransplantation studies, coordinating all study activities from protocol initiation through closeout, ensuring adherence to protocol timelines, milestones, and deliverables while proactively identifying and mitigating risks.
Plan, manage and coordinate surgical schedules, animal procurement and care logistics, and operating room resources in collaboration with transplant surgeons, veterinary teams, and facility managers to ensure timely and ethical execution of xenotransplant procedures.
Prepare, submit, and maintain regulatory documents for IACUC and IRB approvals, including protocol amendments, study renewals, and safety reports, and act as the point person for responding to regulatory queries and inspections.
Oversee biospecimen management workflows including collection, labeling, chain-of-custody, processing, storage, and shipment of xenograft material and biological samples in accordance with biosafety regulations, chain-of-custody requirements, and study SOPs.
Coordinate and document Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) interactions related to xenograft production, storage, and release testing, partnering with manufacturing and QC teams to ensure product traceability and batch documentation.
Implement and maintain study-specific standard operating procedures (SOPs), work instructions, and training logs, ensuring all team members are trained on xenotransplant-specific hazards, aseptic techniques, animal welfare protocols, and emergency procedures.
Manage study budgets, purchasing, vendor selection and contract negotiation for xenograft supply, surgical disposables, specialized instrumentation, and lab services while tracking spend against grant or departmental budgets.
Maintain the electronic Trial Master File (eTMF), site files, and study documentation with complete, audit-ready records including consent forms, protocol versions, monitoring reports, and deviation logs.
Coordinate adverse event (AE) and serious adverse event (SAE) reporting processes for preclinical and clinical xenotransplant studies, ensuring timely internal escalation and regulatory reporting to sponsors and relevant oversight bodies.
Facilitate multidisciplinary study meetings, prepare study reports, meeting minutes, and materials for investigators, sponsors, and oversight committees, and translate technical findings into clear operational action items.
Oversee data capture and integrity by managing electronic data capture (EDC) systems, REDCap instances, or CTMS entries; implement data validation checks, resolve queries, and work with biostatistics and data management to ensure high-quality datasets suitable for publication and regulatory submission.
Supervise and mentor junior research staff, animal technicians, and clinical coordinators assigned to xenotransplant studies, conducting performance management, training needs assessments, and cross-functional onboarding.
Ensure compliant handling, transport, and import/export documentation for xenogeneic tissues and biological materials, working with institutional biosafety officers and customs specialists to meet local and international regulatory requirements.
Manage vendor and CRO relationships for specialized services such as pathogen screening, immunologic assays, histopathology, and device testing, defining scopes of work, monitoring deliverables, and ensuring contractual compliance.
Coordinate quality assurance activities including internal and external audits, corrective and preventive actions (CAPAs), root cause analyses for deviations, and continuous improvement initiatives specific to xenotransplant operations.
Oversee environmental monitoring, sterilization validation, and facility certifications relevant to xenotransplant workspaces, ensuring cleanroom, BSL (biosafety level), and surgical suite compliance where applicable.
Develop and manage the sample tracking and inventory system for xenograft lots, reagents, and critical supplies, implementing barcoding or RFID systems where possible to reduce human error and improve traceability.
Support translational endpoints by coordinating collection of clinical and laboratory outcome measures, immunological monitoring, imaging, and functional assessments, ensuring data are collected per protocol and standardized across sites.
Lead pre-study site assessments and readiness checks, including equipment calibration, cold-chain logistics verification, staffing adequacy, and biosafety risk assessments prior to study start.
Prepare and contribute to regulatory submissions and sponsor-facing documentation such as IND/IDE packages (as applicable), investigator brochures, and clinical trial applications by compiling operational and compliance-related content.
Design and coordinate study-specific training programs for surgical staff, veterinary personnel, lab technicians, and external collaborators on xenotransplant workflows, animal welfare, biosafety, and emergency response procedures.
Serve as the primary contact for institutional biosafety committees, transplant oversight committees, and external sponsors on operational questions, ensuring transparent communication and timely resolution of issues.
Track study metrics and KPIs (recruitment, enrollment, procedural success rates, sample quality metrics, regulatory milestones) and prepare executive-level dashboards and reports to inform leadership decisions and strategic planning.

Secondary Functions

Support manuscript preparation, posters, and grant applications by providing study-level operational data, timelines, and methods descriptions.
Assist in the development and continuous refinement of institutional xenotransplant policies and best practices based on lessons learned and regulatory updates.
Contribute to vendor qualification initiatives and support procurement-led due diligence for new suppliers of xenograft materials and testing services.
Provide on-call support for study-related urgent events and coordinate emergency responses involving xenograft material or adverse animal/human events.
Participate in cross-functional strategic planning to harmonize xenotransplant initiatives with institutional translational research goals.
Facilitate knowledge transfer by maintaining a centralized repository of study templates, SOPs, and training materials optimized for reuse across projects.

Required Skills & Competencies

Hard Skills (Technical)

Clinical/Preclinical Study Coordination: Proven experience coordinating complex translational studies including surgical schedules, specimen workflows, and multidisciplinary teams.
Regulatory Submissions & Compliance: Hands-on experience preparing IACUC and IRB submissions, protocol amendments, renewals, and safety reporting; familiarity with FDA frameworks (IND/IDE) is highly desirable.
Good Manufacturing/Good Laboratory Practices: Knowledge of GMP/GLP requirements, batch documentation, and manufacturing release processes relevant to xenograft production.
Biosafety & Animal Welfare: Strong understanding of biosafety principles, zoonotic risk mitigation, animal welfare regulations, and institutional biosafety committee processes.
Data Management & EDC Tools: Proficiency with REDCap, eCRFs, CTMS, eTMF, and basic data management practices including query resolution and data cleaning.
Laboratory & Specimen Logistics: Experience designing and overseeing sample collection, processing, cold-chain logistics, labeling, and chain-of-custody documentation.
Quality Systems & Audits: Experience with internal/external audits, CAPA processes, SOP development, and corrective action implementation.
Vendor & Contract Management: Experience creating statements of work, managing CROs and vendors, and tracking deliverables and SLAs.
Project Management: Strong project planning skills including Gantt chart development, milestone tracking, budget management, and risk mitigation.
Clinical/Preclinical Safety Reporting: Familiarity with AE/SAE documentation, escalation processes, and regulatory timelines.
Technical Writing: Ability to draft operational sections of regulatory submissions, SOPs, study manuals, and scientific abstracts.
Systems & Tools: Comfortable with Microsoft Office, electronic lab notebooks (ELNs), inventory management systems, and basic statistics or data visualization tools (e.g., Excel, Tableau).

Soft Skills

Excellent written and verbal communication, able to translate technical / scientific concepts into clear operational plans for diverse stakeholders.
Strong organizational skills with attention to detail and the ability to manage multiple concurrent studies and competing priorities.
Leadership and team-building experience, including mentoring junior staff and coordinating cross-disciplinary teams.
Critical thinking and problem-solving aptitude to identify root causes and implement pragmatic solutions under time pressure.
Stakeholder management and diplomacy, able to negotiate schedules, resources, and competing priorities across clinical, veterinary, and laboratory teams.
Adaptability and resilience in a high-regulation, high-stakes research environment.
Ethical judgment and sound decision-making with a focus on patient safety and animal welfare.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree in Biological Sciences, Nursing, Veterinary Science, Health Sciences, or related field.

Preferred Education:

Master's degree in Transplant Immunology, Clinical Research, Public Health, or an MD/PharmD/RN with research experience.
Certifications such as CCRP (Certified Clinical Research Professional), CCRC, or RAC are advantageous.

Relevant Fields of Study:

Transplantation Biology
Immunology / Immunoengineering
Veterinary Medicine / Comparative Medicine
Clinical Research / Public Health
Biomedical Engineering / Biomanufacturing

Experience Requirements

Typical Experience Range: 3–7 years coordinating clinical or preclinical transplant, immunology, or surgical research studies, with demonstrated exposure to IACUC and IRB processes.

Preferred: 5+ years of direct xenotransplantation or organ transplantation research coordination, hands-on experience with GMP/GLP workflows, and documented involvement in regulatory submissions and sponsor-facing study management.