CRA SSU – Regulatory and Monitoring Specialist

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

📋 Description

• Conducts site qualification, site initiation, interim monitoring, site management tasks, and close-out visits (either on-site or remotely), ensuring adherence to regulatory standards, ICH-GCP, Good Pharmacoepidemiological Practices (GPP), and protocol compliance.

• Utilizes judgment and expertise to assess the overall performance of sites and their personnel, providing recommendations for site-specific actions; promptly communicates/escalates significant issues to the project team and collaborates on developing action plans.

• Maintains a thorough understanding of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.

• Ensures that the process of obtaining informed consent has been properly executed and documented for each subject/patient, as required or appropriate.

• Shows diligence in safeguarding the confidentiality of each subject/patient.

• Evaluates factors that may impact the safety of subjects/patients and the integrity of clinical data at an investigator/physician site, including protocol deviations/violations and pharmacovigilance concerns.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other applicable regulatory standards.

• Must possess strong computer skills and be open to adopting new technologies.

• Exceptional communication, presentation, and interpersonal abilities.

• Willingness to manage required travel of up to 75% on a regular basis.

🏝️ Benefits

• We are dedicated to nurturing our employees through career development and progression, supportive and engaged line management, technical and therapeutic training, peer recognition, and a comprehensive rewards program.

• We are devoted to fostering an inclusive culture where you can genuinely be yourself. This is central to our mission – Driven to Deliver – which embodies the enthusiasm of our colleagues to show up daily and create solutions that can significantly impact lives.

• We are continually working towards building a company that our employees are proud to work for and that our clients are eager to collaborate with.