Oncology Clinical Research Associate – Site Monitoring

InnoCare Pharma; Boston (MA); Presencial; USD 90.000 - 120.000; Tempo integral

Resumo da vaga

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Communication skills

English proficiency

Mandarin (spoken)

Formação

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

Ferramentas

CTMS

eTMF

EDC

IWRS/IVRS

Descrição da vaga

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.