CRA Level II
RemoteMexico
Job Summary
Monitor investigator sites using a risk-based approach, applying root cause analysis to identify process failures and drive corrective actions. Ensure data accuracy through source data review, site data verification, and CRF review during on-site and remote visits. Manage procedures for sponsors and monitoring environments, including investigator payments and trial closeouts. Initiate clinical trial sites, conduct file reviews, and maintain study systems per project specifications. Facilitate communication between sites, the client company, and the PPD project team while responding to regulatory audits. Provide trial status tracking reports and contribute to project publications and process improvement initiatives.
Required Qualifications
- Bachelor's degree in a life sciences related field
- Registered Nursing certification
- 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)
- completion of PPD Drug Development Fellowship
- Valid driver's license
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
- Ability to manage Risk Based Monitoring concepts and processes
- Good oral and written communication skills
- Ability to communicate effectively with medical personnel
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
- Good organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Ability to remain flexibile and adaptable in a wide range of scenarios
- Ability to work in a team or independently as required
- Good computer skills: solid knowledge of Microsoft Office
- ability to learn appropriate software
- Good English language and grammar skills
- Good presentation skills
- Frequent travel, generally 60-80% but more for some individuals
- extended overnight stays
- Exposure to biological fluids with potential exposure to infectious organisms
- Personal protective equipment required such as protective eyewear, garments and gloves
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