Note: The job is a remote job and is open to candidates in USA. InnoCare Pharma is a commercial-stage biopharmaceutical company developing and commercializing innovative treatments for cancer and autoimmune diseases. The Clinical Research Associate will conduct and oversee clinical trial site monitoring activities, ensure data quality and regulatory compliance, manage site performance and investigational products, and collaborate with cross-functional study teams in oncology trials.
Responsibilities
- 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
Skills
- 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
- This job is locate in China or USA
- Mandarin (spoken) – a plus
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