Clinical Research Associate

hace 2 días

Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo

Clinical Research Associate Job Summary:


We are seeking a highly skilled Clinical Research Associate to join our team at Thermo Fisher Scientific. This role 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:



  • Monitors investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification).
  • Assesses investigational product through physical inventory and records review.
  • Documents observations in reports and letters in a timely manner using approved business writing standards.
  • Escalates observed deficiencies and issues to clinical management expeditiously, proposes solutions and follows all issues through to resolution.
  • Maintains 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.
  • Conducts monitoring tasks in accordance with the approved monitoring plan.
  • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as needed.
  • Participates in investigator meetings as vital and identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
  • Initiates clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
  • Ensures trial close out and retrieval of trial materials.
  • Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
  • Performs additional study tasks as assigned by CTM (trip report review, newsletter creation, lead CRA team calls, etc.).
  • Manages crucial documents, as required by local regulations and ICH GCP, before, during, and after a clinical trial.
  • Facilitates effective communication between investigative sites, the client company, and the PPD project team through written, oral, and/or electronic contacts.
  • Responds to company, client, and federal regulatory requirements/audits.
  • Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.

Requirements:


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).


Valid driver's license where applicable.


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.


Additional Requirements:


Based on Barranquilla or Cali.


Availability to travel/visit sites.

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