Clinical Research Associate

InnoCare Pharma; Boston (MA); On-site; USD 85,000 - 125,000; Full time

Job summary

InnoCare Pharma in the United States seeks an experienced on-site Clinical Research Associate to monitor oncology trials (Phase I-III/IV) per ICH-GCP and study plans, ensuring data accuracy and site performance.

You will manage IP accountability, oversee essential documents in eTMF, and collaborate with cross-functional teams, requiring a life sciences degree and 2–3 years of on-site monitoring experience.

Qualifications

• Bachelor's degree in Life Sciences, Nursing or Pharmacy.
• Minimum 2–3 years of on-site CRA monitoring experience.
• Direct oncology trial monitoring experience (Phase I-III/IV) required.

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 and completeness.
• Manage site performance, including patient recruitment, retention, and issue resolution.
• Oversee investigational product 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 for monitoring.
• Track and report SAEs, deviations, and escalate compliance issues.
• Prepare monitoring visit reports using CTMS within timelines.
• Serve as primary site contact and collaborate with cross-functional teams.

Skills

On-site monitoring

Clinical Research Associate

IP/SAE tracking

Communication skills

Education

Bachelor's degree in Life Sciences/Nursing/Pharmacy

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