• Lead clinical study in execution, including planning, conduct, data review, and reporting for Phase I and II trials in hematologic malignancies • Own ongoing clinical data review, ensuring patient safety and data integrity; identify trends and drive data informed decisions • Lead safety monitoring activities including review of adverse events and CAR-T associated toxicities (ie: CRS, ICANS) and contribute to dose escalation decisions • Drive cross-functional collaboration with Clinical Operations, Translational Sciences, Data Management, Biostatistics, Regulatory, and CMC teams to ensure high-quality study execution • Lead authorship of key study documents, including protocols, Investigator’s Brochures, clinical study reports, regulatory documents, and safety narratives • Integrate clinical and translational data (ie: cell expansion, persistence, biomarker data) to generate insights and inform program strategy • Contribute to regulatory strategy and submissions, including IND-related documents and health authority responses • Serve as a scientific lead at the study level, engaging with investigators, CROs, and key opinion leaders • Support development of publications, abstracts, and presentations for scientific conferences • Ensure compliance with GCP, internal SOPs, and regulatory requirements

Role Description The Clinical Education Fellow (CEF) position will assist students in their transition to clinical training beginning during the Step 1 LOA and into year 3. CEFs will work closely with students during the Step 1 LOA to coach, advise, and assess readiness for Step 1 through recommendation of resources, study plans, practice exams and connection to AUC. They will also support students after Step 1 during the Transition to Clinical Medicine Program (TCM) as students begin clerkships. - Act as coach for students as they navigate their third year of medical school, including expectations for clerkships, examination information and guidance for NBME Shelf Exams, as well as Step 1 and Step 2. - Meet with AUC students during their Step 1 LOA and during clerkships in TCM. - Provide instruction and facilitate students’ use of Canvas and Medtrics. - Demonstrate learning resources available to students and encourage their use in preparation for exams and clerkships. - Review students’ use of learning resources and facilitate students’ ongoing use of Medtrics for patient logging and completion of evaluations. - Create a sense of connectedness among student cohorts and AUC through ongoing engagement. - Facilitate discussion and reflective practice regarding academic performance, progress, and readiness as appropriate. - Refer students to the appropriate departments and resources. - Completes other duties as assigned. - Performs other duties as assigned. - Complies with all policies and standards. Qualifications - Must be a recent medical school graduate of AUC. - Must have the M.D. degree and completion of all rotations. - Satisfactory or better grade in 5th semester. - Excellent English communication skills. - Strong teaching skills and experience or evidence of potential. - Desire for self-improvement. - Flexibility and ability to work well on a team. - Must demonstrate exceptional professionalism. - Ability to research queries independently. - Understanding of when to handle something independently and when to take it to the team or manager. - Experience with some of AUC’s clinical education placements. - Strong writing skills. - Strong study skills. - Familiarity working with medical students and familiarity with NBME and USMLE exams. Requirements - Note: position is ONLY for American University of the Caribbean School of Medicine 2025 and 2026 graduates. Benefits - Health, dental, life and disability insurance. - 401k Retirement Program + 6% employer match. - 7.5 Days of Paid Time Off (PTO) each Calendar Year. - 12 Paid Holidays + 1 floating holiday.

• Develop designs of clinical studies to support regulatory submissions (FDA 510(k), PMA, CE-IVDR) for Immunohistochemistry (IHC) & In Situ Hybridization (ISH), Companion Diagnostics (CDx) and Medical Device, ensuring compliance with Good Clinical Practice (GCP), ISO standards, and applicable regulatory requirements. • Serve as a clinical and scientific liaison with regulatory agencies, key opinion leaders, and external clinical sites, providing expert guidance through creation of study protocols, clinical claims, and evidence generation strategies. • Author and review critical regulatory documents including clinical study reports, technical files, and scientific publications to support product clearance, approval, and commercialization. • Establish and maintain strong collaborative relationships with internal cross-functional teams (e.g., R&D, Regulatory Affairs, Medical Affairs, Quality Assurance, Data Management, Clinical Operations, Commercial) and external partners (e.g., CROs, investigators, key opinion leaders) to ensure successful clinical program execution. • Support and mentor junior clinical scientists and contribute technical expertise to cross-functional teams, while staying informed on relevant regulatory expectations, clinical guidelines, and emerging diagnostic technologies in the IVD space.

• Provide leadership and direction to clinical site management team members from study start through to closure • Serve as Site Management primary point of contact and representative for clinical monitoring and site activities within the project • Manage monitoring deliverables to achieve study budget and identify Out of Scope Activities • Oversee compliance to the Clinical Monitoring Plan