Clinical Research Associate
Vor 7 Tagen
Thermo Fisher Scientific is seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will play a critical role in ensuring the success of our clinical trials by providing site management and monitoring services.
Key Responsibilities- Perform and coordinate all aspects of clinical monitoring and site management, ensuring compliance with regulatory requirements and company policies.
- Conduct remote or on-site visits to assess protocol and regulatory compliance, and manage required documentation.
- Act as a site processes specialist, ensuring that trials are conducted in accordance with approved protocols, ICH-GCP guidelines, and applicable regulations.
- Ensure audit readiness and develop collaborative relationships with investigational sites.
- Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site processes failures and implement corrective actions.
- Ensure data accuracy through source data verification, site data review, and CRF review, as applicable.
- Assess investigational products through physical inventory and records review.
- Document observations in reports and letters in a timely manner, using approved business writing standards.
- Bring up observed deficiencies and issues to clinical management promptly and follow through to resolution.
- Participate in investigator meetings, as necessary, and provide trial status tracking and progress update reports to the Clinical Team Manager.
- Ensure study systems are updated per agreed study conventions, and perform quality control checks of reports generated from the Clinical Trial Management System.
- Bachelor's degree in a life sciences-related field or a Registered Nursing certification, or equivalent and relevant formal academic/vocational qualification.
- Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
- Valid driver's license.
- Full right to work in Germany.
- Fluency in English and German language to at least C1 level.
- 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 critical attitude, in-depth investigation for appropriate root cause analysis, and decision-making.
- Ability to handle 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 good listening skills, attention to detail, and the ability to perceive customers' underlying issues.
- Effective social 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 presentation skills.
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