Senior Clinical Research Associate

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

📋 Description

• Oversee and coordinate clinical monitoring and site management tasks.

• Perform remote and on-site visits to evaluate adherence to protocols and regulatory standards.

• Manage necessary documentation, sponsor processes, and monitoring protocols.

• Ensure trials align with approved protocols, ICH-GCP standards, regulations, and SOPs.

• Cultivate collaborative relationships with investigational sites and client personnel.

• Assist project and clinical team managers and lead assigned tasks as needed.

• Mentor, train, and help develop junior clinical team members.

• Monitor investigator sites utilizing a risk-based monitoring strategy.

• Utilize root cause analysis, critical thinking, and problem-solving to pinpoint process failures and implement corrective and preventive actions.

• Guarantee data accuracy through SDR, SDV, and CRF reviews during both on-site and remote monitoring.

• Evaluate investigational product inventory and maintain records.

• Document findings in reports and letters, and escalate deficiencies until resolved.

• Maintain communication with investigative sites between monitoring visits.

• Track trial status and deliver progress updates to the Clinical Team Manager.

• Update clinical study systems, such as CTMS, and conduct quality-control checks on CTMS reports.

• Participate in investigator meetings.

• Identify potential investigators and initiate clinical trial sites.

• Oversee trial closeout and the retrieval of trial materials.

• Ensure all essential documents are complete and conduct on-site file reviews.

• Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls.

• Facilitate communication between sites, clients, and the PPD project team.

• Address company, client, and regulatory requirements, audits, and inspections.

• Complete expense reports and timesheets.

• Contribute to initiatives aimed at process improvement.

⛳️ Requirements

• A Bachelor's degree in a life science-related field or an equivalent formal academic/vocational qualification.

• Significant clinical research monitoring experience, typically over 5 years.

• Proven expertise in all facets of clinical monitoring.

• Advanced clinical monitoring skills.

• Thorough understanding of FDA guidelines, ICH GCPs, relevant regulations, and procedural documents.

• Outstanding critical thinking, root cause analysis, and problem-solving abilities.

• Proficient in Risk Based Monitoring concepts and procedures.

• Capability to assess medical research data.

• Strong knowledge of medical terminology.

• Exceptional oral and written communication skills.

• Customer-oriented approach.

• Excellent interpersonal abilities.

• Strong organizational and time management skills.

• High attention to detail.

• Flexibility and adaptability.

• Effective presentation skills.

• Good digital literacy and proficiency in Microsoft Office applications.

• Willingness to travel frequently, typically 60–80%, including potential extended overnight stays.

• Ability to work in various environments such as offices, laboratories, clinical settings, and home offices.

• Capability to remain upright and/or stationary for 6–8 hours per day.

• Frequent mobility required.

• Ability to lift and carry weights of 15–20 lbs.

• Capacity to access and use a range of computer software.

• Regular and consistent attendance is expected.

🏝️ Benefits

• Annual incentive plan bonus.

• Comprehensive healthcare coverage.

• Employee benefits package.

• Opportunities for career and professional development.

• Be part of an innovative, forward-thinking organization.

• Company culture focused on integrity, intensity, involvement, and innovation.