Senior Clinical Research Associate, Chile

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

📋 Description

• Take charge of study site management independently to ensure patient safety and maintain high standards of data quality.

• Provide guidance at both site and project levels to ensure audit readiness and assist with audit preparation and follow-up procedures.

• Keep study-specific trial management tools, systems, and status reports updated.

• Oversee site start-up, assess investigator feasibility and recruitment, manage EC/IRB submissions, handle regulatory documents, informed consents, notifications, translations, and organize meetings.

• Assist with negotiations regarding study budgets and execution of investigator contracts as required.

• Verify the processes for informed consent and evaluate patient safety, data integrity, protocol deviations, violations, and pharmacovigilance issues.

• Conduct visits for pre-study, qualification, initiation, routine monitoring, close-out, and provide monitoring oversight, both on-site and remotely.

• Prepare monitoring reports in a timely manner and document activities in accordance with SOPs, monitoring plans, and client specifications.

• Support strategies for patient recruitment, retention, and awareness; track observations and resolve action items.

• Review Investigator Site Files and ensure they align with Trial Master Files.

• Communicate any study-related issues to site personnel as well as Precision project and clinical trial management teams.

• Foster relationships with investigators and study staff while embodying Precision’s professional image.

• Manage the inventory of investigational products, ensuring compliance in reconciliation, storage, security, dispensing, administration, labeling, import, and return/release.

• Conduct reviews of EDC CRF and patient-profile data, address queries, and assist with data discrepancies.

• Identify and process Serious Adverse Events following study protocols.

• Recognize site risks, escalate them appropriately, and ensure timely resolution with project-team oversight.

• Attend meetings for investigators, sponsors, global monitoring, and clinical training.

• Assist in the development of protocols, study documentation, CRF design, monitoring materials, and clinical study reports.

• Mentor and train new hires and junior monitors.

• Engage with clients and contribute to proposals and client presentations.

• Initiate requests for investigator payments.

• Travel as required based on project needs.

⛳️ Requirements

• A 4-year college degree or equivalent experience in a scientific or healthcare field.

• At least 5 years of experience as a CRA in a CRO or the pharmaceutical/biotech industry, or relevant experience and demonstrated competencies.

• Significant experience in site management or similar experience in clinical research.

• Strong professional-level English communication skills, both verbal and written.

• Experience in monitoring rare and complex therapeutic areas.

• Proficient in monitoring EDC trials and EHR records.

• Background in biopharma or a relevant therapeutic area.

• Relevant country-specific experience in site start-up, including feasibility assessments, contract negotiations, and submissions.

• Capability to monitor study sites according to protocol monitoring guidelines, SOPs, GCP, and ICH standards.

• Willingness to travel overnight; average travel up to 60%, including international travel as necessary.

• Oncology experience may be necessary for certain opportunities, preferably in early phases.

• Familiarity with clinical trial methodology, protocols, and study indications.

• Ability to deliver formal presentations to colleagues, investigative staff, and clients.

• Capacity to work independently and collaboratively within a team environment.

🏝️ Benefits

• Flexible remote work arrangement.

• Commitment to equal opportunity employment.

• Reasonable accommodations available for applicants with disabilities.