CRA (Level II) FSP - Bulgaria
On-siteSofia, Sofia-Capital, Bulgaria
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, while assessing investigational product through physical inventory and records checks. Manage procedures across various environments, ensure audit readiness, and facilitate communication between sites, clients, and project teams. Initiate clinical trial sites, perform trial closeouts, and provide status tracking reports to the Clinical Team Manager. Respond to regulatory requirements and audits, maintaining essential documents and completing administrative tasks such as expense reports.
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, 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
- May also include extended overnight stays
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