About the role
Inno Care (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune disease, with unmet medical needs worldwide. Inno Care has built up a fully integrated platform in terms of research and development, clinical development, manufacturing and commercialization. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), and more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. Inno Care has successfully got listed on both Hong Kong Stock Exchange and the STAR Board of Shanghai Stoch Exchange. Our world-class team exhibits remarkable synergy and efficient execution, with entrepreneurial spirit, which has made outstanding achievements in innovation, commercialization and globalization. If you would like to join us, we will develop innovative drugs for the benefit of patients worldwide. Website link: https://www.innocarepharma.com/en. Linked In: Inno Care Pharma. Key Responsibilties Conduct site selection, initiation, routine monitoring, and close-out visits per ICH-GCP and study-specific monitoring plans. Perform source data review (SDR), source data verification (SDV), and CRF review to ensure data accuracy and completeness. Manage site performance, including patient recruitment, retention, and issue resolution. Oversee investigational product (IP) accountability, storage, and handling at sites. Ensure timely collection and filing of essential documents in eTMF, maintaining audit readiness. Apply oncology-specific knowledge including RECIST 1.1 and CTCAE grading for adverse event and tumor response monitoring. Track and report SAEs, protocol deviations, and escalate compliance issues as needed. Prepare and finalize monitoring visit reports within required timelines using CTMS.Serve as primary site contact, building strong site partnerships. Collaborate with Data Management, Drug Safety, and cross-functional study teams.
Requirements:
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field. Minimum 2–3 years of on-site CRA monitoring experience in a CRO, pharma, or biotech. Minimum 2 years of direct oncology trial monitoring experience (Phase I–III/IV) – non-negotiable. Solid knowledge of ICH-GCP, FDA regulations, and US clinical research requirements. Familiarity with RECIST criteria and CTCAE grading system. Proficiency with CTMS, eTMF, EDC, and IWRS/IVRS.Strong written/verbal communication skills in English. Mandarin (spoken) – a plus This job is locate in China or USA
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