About this role

Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation
Monitor investigator sites with a risk-based monitoring approach
Escalate observed deficiencies and issues to clinical management, following all issues through to resolution
Ensure that required essential documents are complete and in place, according to ICH-GCP and applicable regulations
Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required

Must live in the South/ SE region of the US and have a minimum of 1 year travel monitoring experience in Oncology
Must be Bilingual (English/ Spanish)
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 year as a clinical research monitor) or completion of PPD Drug Development Fellowship
Valid driver's license where applicable

Frequent drives to site locations
Frequent travel, generally 60-80% but more for some individuals
Extended overnight stays required
Personal protective equipment required such as protective eyewear, garments and gloves

Clinical Research Associate II, Bilingual, Oncology

Key skills