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