Senior Clinical Research Associate

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

📋 Description

• Oversee and coordinate clinical monitoring and site management tasks.

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

• Manage essential documentation and sponsor-related procedures.

• Ensure that trials are in compliance with approved protocols, ICH-GCP guidelines, regulations, and standard operating procedures (SOPs).

• Foster collaborative relationships with investigative sites and client personnel.

• Support project or clinical team managers and lead initiatives when necessary.

• Mentor, train, and assist in the development of junior clinical team members.

• Monitor investigator sites using a risk-based approach.

• Utilize root cause analysis, critical thinking, and problem-solving skills to address site process failures.

• Ensure data integrity through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review.

• Evaluate investigational product inventory and maintain accurate records.

• Document findings in reports and letters and escalate any deficiencies as needed.

• Maintain communication with investigative sites between monitoring visits.

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

• Update clinical study systems and conduct quality checks on CTMS reports.

• Participate in investigator meetings and pinpoint potential investigators.

• Initiate clinical trial sites and ensure adherence to regulatory obligations and ICH-GCP standards.

• Oversee trial closeout and retrieval of trial materials.

• Confirm that essential documents are complete and conduct on-site file assessments.

• Assist with project publications, tools, trip report evaluations, newsletters, and CRA team meetings.

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

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

• Complete expense reports and timesheets.

• Contribute to project initiatives and process enhancement efforts.

⛳️ Requirements

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

• Significant clinical research monitoring experience, equivalent to 5+ years.

• Proven expertise in all aspects of clinical monitoring.

• Comprehensive knowledge of FDA guidelines, ICH GCPs, applicable regulations, and procedural documents.

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

• Proficient understanding of Risk-Based Monitoring concepts and processes.

• Demonstrated capability to assess medical research data.

• Solid knowledge of medical terminology.

• Exceptional oral and written communication skills.

• Ability to maintain a customer-focused approach.

• Excellent interpersonal, organizational, and time management abilities.

• Strong attention to detail.

• Flexibility and adaptability across various scenarios.

• Effective presentation skills.

• Good digital literacy and advanced proficiency in Microsoft Office.

• Capability to work in an office, laboratory, clinical, and/or home office environment.

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

• Ability to work upright and/or stationary for 6–8 hours daily.

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

• Regular and consistent attendance is required.

🏝️ Benefits

• Annual incentive plan bonus.

• Healthcare coverage.

• Employee benefits.

• Opportunities for career growth and development.

• Innovative and forward-thinking company culture.

• Accessibility services and accommodations during the application process.