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.

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.

Clinical Research Associate, Level II – FSP Oncology

Key skills