Clinical Research Associate
hace 2 semanas
We are seeking a highly skilled Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Clinical Research Associate, you will be responsible for conducting site visits to assess protocol and regulatory compliance, managing required documentation, and ensuring that data will pass international quality assurance audits.
Key Responsibilities- Monitor investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification).
- Assess investigational product through physical inventory and records review, documenting observations in reports and letters in a timely manner using approved business writing standards.
- Escalate observed deficiencies and issues to clinical management expeditiously, propose solutions, and follow all issues through to resolution.
- Maintain regular contact between monitoring visits with investigative sites to ensure that the protocol is being followed, that previously identified issues are being resolved, and that the data is being recorded in a timely manner.
- Conduct monitoring tasks in accordance with the approved monitoring plan.
- Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as needed, ensuring study systems are updated per agreed study conventions (Clinical Trial Management System, CTMS).
- Participate in investigator meetings as necessary, identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites, and initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations.
- Contribute to the project team by assisting in preparation of project publications/tools, sharing ideas/suggestions with team members, and performing additional study tasks as assigned by CTM.
- Manage crucial documents, as required by local regulations and ICH GCP, before, during, and after a clinical trial.
- Facilitate effective communication between investigative sites, the client company, and the PPD project team through written, oral, and/or electronic contacts, responding to company, client, and federal regulatory requirements/audits.
- Maintain and complete administrative tasks, such as expense reports and timesheets, in a timely manner.
We are looking for a candidate with a 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 4+ years as a clinical research monitor) is required. A valid driver's license where applicable is also necessary. In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Based on Barranquilla or Cali, availability to travel/visit sites is required.
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Clinical Research Associate
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Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo{"title": "Clinical Research Associate", "content": "Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Clinical Research Associate, you will be responsible for coordinating all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, and...
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