Oncology Clinical Research Associate – Site Monitoring

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 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.