Clinical Research Associate, Level II – FSP Oncology
Posted 2026-05-06
Remote, USA
Full-time
Immediate Start
- Job Description:
- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
- Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
- Assess investigational product through physical inventory and records review.
- Documents observations in reports and letters in a timely manner using approved business writing standards.
- Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
- Conducts monitoring tasks in accordance with the approved monitoring plan.
- Participates in investigator meetings as necessary.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
- Requirements:
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
- Minimum 1 year oncology therapeutic experience.
- Valid driver's license where applicable.
- Benefits:
- Work Schedule Standard (Mon-Fri)
- Office
- Flexible working hours