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Clinical Research Associate
2 meses atrás
We are seeking a highly skilled and experienced Clinical Research Associate (CRA) to join our team at Thermo Fisher Scientific. As a Sr. CRA, you will play a critical role in the success of our clinical trials, working closely with investigators, clients, and project teams to ensure the smooth execution of studies.
Key Responsibilities- Monitor investigator sites with a risk-based approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site processes failures and implement corrective/preventive actions.
- Ensure data accuracy through source document verification, site visits, and CRF review, as applicable.
- Assess investigational products through physical inventory and records review.
- Document observations in reports and letters in a timely manner, adhering to approved business writing standards.
- Escalate observed deficiencies and issues to clinical management promptly and follow through to resolution.
- Maintain regular contact with investigative sites to confirm protocol adherence, resolve issues, and ensure timely data recording.
- Conduct monitoring tasks in accordance with the approved monitoring plan.
- Participate in investigator meetings, identify potential investigators, and ensure site acceptability.
- Initiate clinical trial sites, ensuring compliance with protocols, regulatory, and ICH GCP obligations.
- Ensure trial close-out and retrieval of trial materials.
- Contribute to the project team by mentoring new members, assisting in project publications, and sharing ideas/suggestions.
- Perform additional tasks as assigned by the Clinical Team Manager or Clinical Manager of CRAs.
- Bachelor's degree in a life science-related field or a Registered Nursing certification or equivalent.
- Previous experience as a clinical research monitor, with a minimum of 3 years of experience.
- Valid driver's license, where applicable.
- Knowledge, skills, and abilities in clinical monitoring, critical thinking, problem-solving, and effective communication.