Clinical Research Associate

InnoCare Pharma; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

InnoCare Pharma is seeking an experienced Clinical Research Associate (CRA) to monitor oncology trials in the United States. You will perform site visits, data reviews, and ensure regulatory compliance across study sites.

The ideal candidate has 2–3 years of on-site CRA experience, familiarity with RECIST/CTCAE, and proficiency with CTMS/eTMF/EDC. Mandarin is a plus. This role requires strong communication skills and collaboration with cross-functional teams.

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
• 2–3 years of on-site CRA monitoring experience in a CRO/pharma/biotech.
• 2 years of direct oncology trial monitoring (Phase I–III/IV) required.
• Solid knowledge of ICH-GCP, FDA regulations, and US clinical research.
• Familiarity with RECIST criteria and CTCAE grading.

Responsibilities

• Conduct site selection, initiation, routine monitoring, and close-out visits per ICH-GCP and study plans.
• Perform SDR, SDV, and CRF review to ensure data accuracy.
• Manage site performance including patient recruitment, retention, and issue resolution.
• Oversee IP accountability, storage, and handling at sites.
• Ensure timely collection and filing of essential documents in eTMF.
• Apply oncology knowledge including RECIST 1.1 and CTCAE grading.
• Prepare monitoring visit reports within timelines using CTMS.
• Serve as primary site contact, building strong site partnerships.

Skills

Communication skills

English proficiency

Mandarin (spoken)

Education

Bachelor’s degree in Life Sciences/Nursing/Pharmacy or related field

Tools

CTMS

eTMF

EDC

IWRS/IVRS

Job description

InnoCare (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. InnoCare 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. InnoCare 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. LinkedIn: InnoCare 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 elevate 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