Sr CRA (Level I)

Thermo Fisher Scientific; México; A distancia; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A leading scientific company in Mexico is seeking a Clinical Monitor to ensure compliance with clinical trial processes. The role involves monitoring investigator sites, conducting source data verification, and facilitating communication between stakeholders. Ideal candidates will have strong problem-solving skills and experience in clinical monitoring. This position is crucial for ensuring data integrity and compliance with regulatory requirements.

Formación

• Strong critical thinking and problem-solving skills.
• Proven experience in risk-based monitoring and data accuracy verification.
• Excellent documentation and report writing capabilities.

Responsabilidades

• Monitors investigator sites to ensure compliance and reduce risks.
• Conducts monitoring tasks in line with the approved monitoring plan.
• Communicates effectively with investigative sites and project teams.

Descripción del empleo

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Monitors investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify site processes failures and corrective/preventive actions to bring the site into compliance and decrease risks.

Ensures data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review as applicable through on-site and remote monitoring activities. 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 and follows all issues through to resolution.

Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process and ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.

Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System, CTMS). Performs Quality Control (QC) check of reports generated from the CTMS system where required.

Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the 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. Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.

Contributes to the project team by assisting in the preparation of project publications/tools and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by the CTM (e.g., trip report review, newsletter creation, lead CRA team calls, etc.).

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 applicable regulatory requirements/audits/inspections.

Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner. Contributes to other project work and initiatives for process improvement, as required.