Senior CRA, FSP

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

📋 Description

• Assist in the identification of potential investigators.

• Provide support for study initiation and regulatory upkeep, which includes conducting site qualification visits and submitting necessary documents to EC/IRB and regulatory authorities.

• Educate, assist, and guide investigators and site personnel on study-related issues, incorporating Risk Based Quality Management principles.

• Verify that site staff complete the required training and maintain readiness for inspections.

• Participate in Local Study Team meetings and National Investigators meetings as necessary.

• Initiate, oversee, and close study sites in accordance with relevant procedures.

• Communicate patient recruitment and site quality/performance data with the Local Study Team.

• Enhance site performance, address study-related challenges, and appropriately escalate issues.

• Update the CTMS and other systems with site information within specified timelines.

• Manage study supplies, including drug supplies and accountability; prepare study drugs for destruction when necessary.

• Conduct remote and onsite monitoring visits along with remote data checks following the study Monitoring Plan.

• Execute Source Data Review, Case Report Form review, and Source Data Verification.

• Perform Site Quality Risk Assessments and adjust monitoring intensity throughout the study.

• Ensure prompt resolution of data queries and collaborate with data management to maintain study data quality.

• Guarantee accurate and timely reporting and follow-up of Serious Adverse Events.

• Prepare and finalize monitoring visit reports in the CTMS, providing timely feedback to Principal Investigators.

• Follow up on pending site actions.

• Escalate any systematic or significant quality problems, data privacy violations, or compliance issues related to CSP or ICH-GCP.

• Aid sites in keeping inspection-ready Investigator Site Files.

• Prepare for and collaborate during audits and regulatory inspections.

• Ensure timely collection and upload of essential documents into the eTMF and assist with quality-control checks.

• Confirm that study documents are prepared for final archiving and completion of the local eTMF.

• Provide market feedback related to research on sites, investigators, and competing studies.

• Adhere to AstraZeneca’s Code of Ethics, policies, procedures, and applicable legislation.

• Collaborate with local MSLs as directed.

⛳️ Requirements

• A minimum of 3–5 years' experience in a monitoring role.

• Capability to work autonomously and monitor all phases of a study across different stages.

• Specialized therapeutic knowledge in oncology.

• Ability to undertake LST responsibilities and assist the LST with coordination or document preparation as necessary.

• Willingness to travel internationally as needed.

• Valid driver's license.

• Knowledge of ICH-GCP and adherence to its requirements.

• Ability to comply with AZ Procedural Documents and relevant local regulations.

• Proficiency in conducting monitoring, source data review, CRF review, and source data verification activities.

• Competence in managing study-site documentation, supplies, drug accountability, and essential documents.

• Familiarity with CTMS and other study systems.

• Skill in ensuring timely resolution of data queries and reporting of serious adverse events.

• Capability to assist with audits, regulatory inspections, quality processes, and maintaining inspection readiness.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work hours.