CRA (Level I)

Thermo Fisher Scientific; São Paulo; Presencial; BRL 40.000 - 80.000; Tempo integral

Resumo da oferta

An established industry player is seeking a CRA (Level I) to join their team. This role involves monitoring clinical trial sites, ensuring compliance with protocols, and maintaining data accuracy through thorough reviews. The ideal candidate will possess strong critical thinking and problem-solving skills, with a background in life sciences or nursing. Frequent travel is expected, providing opportunities to engage with diverse teams and contribute to impactful research. If you're passionate about clinical trials and eager to make a difference in healthcare, this position offers a dynamic and rewarding environment.

Qualificações

• 2+ years of clinical monitoring experience in a clinical environment.
• Knowledge of medical terminology and anatomy is essential.

Responsabilidades

• Monitor investigator sites and ensure compliance with protocols.
• Document observations and escalate issues to clinical management.
• Conduct on-site file reviews and maintain communication with sites.

Conhecimentos

Critical Thinking

Problem-Solving

Data Accuracy

Root Cause Analysis

Communication Skills

Formação académica

Bachelor's degree in Life Sciences

Registered Nursing Certification

Ferramentas

Clinical Trial Management System

Descrição da oferta de emprego

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Essential Functions

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
• Ensures data accuracy through SDR, SDV and 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.
• Maintains regular contact between monitoring visits with investigative sites to confirm protocol adherence, issue resolution, and timely data recording.
• Conducts monitoring tasks in accordance with the approved monitoring plan.
• Participates in the investigator payment process and ensures shared responsibility with other project team members on issues/finding resolution.
• Investigates and follows-up on findings as applicable.
• Participates in investigator meetings as necessary.
• Helps identify potential investigators in collaboration with the client to ensure qualified investigative sites.
• Initiates clinical trial sites according to procedures to ensure compliance with the protocol, regulatory, and ICH GCP obligations, making recommendations where warranted.
• Performs 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.
• Provides trial status tracking and progress update reports to the team as required.
• Ensures study systems are complete, accurate, and updated per study conventions (e.g., Clinical Trial Management System).
• Facilitates effective communication between investigative sites, the client company, and internal project teams through written, oral, and electronic contacts.
• Responds to company, client, and applicable regulatory queries.

Qualifications

Education and Experience:

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

Working Conditions and Environment

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