CRA II
RemoteGeorgia, United States
Job Summary
Monitor investigator sites using a risk-based approach, applying root cause analysis to identify process failures and drive corrective actions. Conduct on-site and remote monitoring activities including SDR, SDV, and CRF reviews to ensure data accuracy and protocol compliance. Manage procedures from various sponsors, perform physical inventory assessments, and document observations in reports using approved business standards. Escalate deficiencies to clinical management and facilitate communication between sites, the client company, and the project team. Initiate clinical trial sites, manage investigator meetings, and conduct file reviews to ensure regulatory and ICH-GCP obligations are met. Provide trial status tracking reports, maintain study systems, and respond to audits and inspections. Complete administrative tasks such as expense reports and timesheets while contributing to 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 where applicable
- 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, with the 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 and the 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
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