FSP Clinical Research Associate - Oncology
RemoteVietnam
Job Summary
Monitor investigator sites using a risk-based approach to identify process failures, apply root cause analysis, and implement corrective actions. Ensure data accuracy through source data review, site data verification, and CRF checks while assessing investigational product inventory. Manage procedures from various sponsors, maintain audit readiness, and facilitate communication between sites, the client company, and internal teams. Escalate deficiencies to clinical management and follow issues through to resolution. Participate in investigator meetings, initiate site openings, and perform trial closeouts. Provide status tracking reports and maintain study systems accuracy.
Required Qualifications
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
- Valid driver's license where applicable
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents
- Good oral and written communication skills, with the ability to communicate effectively with medical personnel
- Good interpersonal skills
- 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
- 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 computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills
- Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy
Desired Qualifications
- experience in a health sciences field with formal training in medical terminology and anatomy may be considered
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