CRA (Level I)

Thermo Fisher Scientific; São Paulo; Presencial; BRL 45.000 - 70.000; Tempo integral

Resumo da oferta

An established industry player is seeking a dedicated Clinical Monitor to oversee investigator sites and ensure compliance with protocols. In this role, you will apply critical thinking and problem-solving skills to identify and resolve issues, ensuring data accuracy and adherence to regulations. Your responsibilities will include conducting monitoring tasks, documenting observations, and facilitating communication between investigative sites and internal teams. This position offers the chance to work in a dynamic environment with significant travel opportunities, making it ideal for those passionate about clinical research and patient care.

Qualificações

• 2+ years of clinical monitoring experience in clinical trials or healthcare.
• Formal training in medical terminology and anatomy is a plus.

Responsabilidades

• Monitor investigator sites and ensure compliance with protocols.
• Document observations and escalate issues to clinical management.
• Conduct on-site file reviews and provide trial status updates.

Conhecimentos

Critical Thinking

Problem-Solving

Root Cause Analysis

Data Accuracy

Formação académica

Bachelor's degree in life sciences

Registered Nursing certification

Descrição da oferta de emprego

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Essential Functions

Monitors investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions to ensure compliance and reduce risks. Ensures data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring activities. Assesses investigational products via physical inventory and records review. Documents observations in reports and letters promptly, following approved business writing standards. Escalates deficiencies and issues to clinical management and follows up to resolution. Maintains regular contact with investigative sites between visits to confirm protocol adherence, resolution of previous issues, and timely data recording. Conducts monitoring tasks according to the approved monitoring plan. Participates in the investigator payment process and collaborates with other project team members on issue resolution. Investigates and follows up on findings as needed. Participates in investigator meetings and helps identify potential investigators in collaboration with the client to ensure site suitability. Initiates clinical trial sites in compliance with protocol, regulatory, and ICH GCP obligations, providing recommendations when necessary. Performs trial close-out and retrieval of trial materials. Ensures the completeness and accuracy of essential documents per ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. Provides trial status updates and reports to the team. Ensures study systems are complete, accurate, and updated according to study conventions. Facilitates effective communication between investigative sites, the client, and internal teams via written, oral, and electronic contacts. Responds to company, client, and regulatory inquiries.

Qualifications: Education and Experience

Bachelor's degree in a life sciences-related field, Registered Nursing certification, or equivalent relevant qualification. Minimal clinical monitoring experience (approximately 2 years) in a clinical environment, including clinical trials, medical terminology, research, or healthcare, or formal training in medical terminology and anatomy. Valid driver's license where applicable.

Working Conditions and Environment

Work is performed in office, laboratory, clinical, or home settings with exposure to electrical equipment. Frequent travel to site locations, typically 60-80%, with potential for extended overnight stays. Exposure to biological fluids and infectious organisms, requiring personal protective equipment such as eyewear, garments, and gloves. Occasional exposure to extreme temperatures.