Senior CRA- Oncology- East region
RemoteGeorgia, United States
Job Summary
Monitor investigator sites using a risk-based approach, applying root cause analysis to identify process failures and corrective actions. Ensure data accuracy through source data review, site data verification, and CRF audits while assessing investigational product inventory. Manage procedures for sponsors and monitoring environments, guaranteeing trials adhere to protocol, ICH-GCP guidelines, and SOPs to protect subject rights and data reliability. Provide trial status updates to the Clinical Team Manager, perform QC checks on study system reports, and initiate clinical trial sites in collaboration with the client company. Facilitate communication between sites, the client, and the project team while responding to regulatory audits and inspections. Maintain administrative tasks such as expense reports and timesheets. This role supports top pharmaceutical companies and biotechs across global clinical trials, requiring frequent travel to site locations.
Required Qualifications
- 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 2+ years as a clinical research monitor)
- Minimum 2 years of direct oncology monitoring experience
- Valid driver's license where applicable
- Effective clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Excellent understanding and demonstrated application 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 manages Risk Based Monitoring concepts and processes
- Effective 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
- Effective interpersonal skills
- Strong attention to detail
- Effective organizational and time management skills
- Ability to remain flexible and adaptable in a wide range of scenarios
- Ability to work in a team or independently as required
- Good computer skills: proficient 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
- Exposure to biological fluids with potential exposure to infectious organisms
- Personal protective equipment required such as protective eyewear, garments and gloves
- Must be able to comply with specific sponsor/client/site requirements, even if not required by Thermo Fisher Scientific (e.g., disclosure of vaccination status, or other personal information)
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