Clinical Research Associate

This is a fully remote position, open to applicants in Portugal.

📋 Description

• Monitors investigator sites using a risk-based monitoring strategy: applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify failures in site processes and implement corrective/preventive actions to ensure compliance and mitigate risks.

• Guarantees data accuracy through the review of SDR, SDV, and CRF as applicable via on-site and remote monitoring activities.

• Evaluates investigational products through physical inventory and records assessment.

• Records observations in reports and correspondence promptly, adhering to approved business writing standards.

• Quickly escalates identified deficiencies and issues to clinical management, ensuring all matters are followed through to resolution.

• May be required to maintain regular communication with investigative sites between monitoring visits to verify protocol adherence, confirm resolution of previously identified issues, and ensure timely data recording.

• Executes monitoring tasks as per the approved monitoring plan.

• Engages in the investigator payment process.

• Shares responsibility with other project team members for resolving issues/findings.

• Investigates and follows up on findings as necessary.

• Participates in investigator meetings as required.

• May assist in identifying potential investigators in collaboration with the client company to ensure the qualification of acceptable investigative sites.

• Initiates clinical trial sites in accordance with relevant procedures to ensure adherence to protocols and regulatory and ICH GCP obligations, providing recommendations where appropriate.

• Conducts trial closeout and retrieval of trial materials.

• Ensures all essential documents are complete and compliant with ICH-GCP and applicable regulations.

• Performs on-site file reviews according to project specifications.

• Provides trial status tracking and progress reports to the team as necessary.

• Ensures study systems are complete, accurate, and updated according to agreed study conventions (e.g., Clinical Trial Management System).

• Facilitates effective communication among investigative sites, the client company, and internal project teams through written, oral, and/or electronic correspondence.

• Responds to company, client, and applicable regulatory requirements, audits, and inspections.

• Completes and maintains administrative tasks such as expense reports and timesheets in a timely manner.

• Contributes to the project team by assisting in the preparation of project publications/tools and sharing ideas and suggestions with team members.

• Participates in additional project work and initiatives aimed at process improvement, as necessary.

⛳️ Requirements

• Bachelor’s degree in a life sciences-related field or a Registered Nursing certification or equivalent relevant formal academic/vocational qualification.

• Minimal clinical monitoring experience that provides the knowledge, skills, and abilities necessary to perform the role (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research, or healthcare; or experience in a health sciences field with formal training in medical terminology and anatomy may also be considered.

• Valid driver’s license where applicable. In certain cases, a combination of appropriate education, training, and/or directly related experience may be deemed sufficient for an individual to meet the role’s requirements.

🏝️ Benefits

• Exposure to biological fluids with potential exposure to infectious organisms.

• Required personal protective equipment such as protective eyewear, garments, and gloves.