Senior Clinical Research Associate

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

📋 Description

• Oversee and coordinate clinical monitoring along with site management responsibilities.

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

• Manage necessary clinical trial documentation and uphold sponsor procedures.

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

• Foster collaborative relationships with investigational sites and client personnel.

• Assist project managers and clinical team leaders, taking the lead when necessary.

• Mentor, train, and actively contribute to the development of junior members of the clinical team.

• Monitor investigator sites utilizing a risk-based approach to monitoring.

• Conduct root cause analyses and identify corrective and preventive actions.

• Ensure data integrity through source data review (SDR), source data verification (SDV), and case report form (CRF) assessments.

• Evaluate the inventory and records of investigational products.

• Prepare timely reports and correspondence documenting observations.

• Report deficiencies and track issues until they are resolved.

• Maintain communication with sites between monitoring visits.

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

• Update clinical trial systems, including Clinical Trial Management Systems (CTMS), and conduct quality checks on reports.

• Participate in investigator meetings and identify suitable investigators and sites.

• Initiate clinical trial sites while ensuring compliance with regulatory standards and ICH-GCP guidelines.

• Facilitate trial closeout and retrieval of trial materials.

• Review essential documents and perform on-site file reviews.

• Assist with project publications, tools, trip report assessments, newsletters, and Clinical Research Associate (CRA) team meetings.

• Enhance communication between investigative sites, clients, and project teams.

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

• Complete expense reports, timesheets, and other administrative duties.

• Contribute to initiatives aimed at process improvement.

⛳️ Requirements

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

• Significant experience in clinical research monitoring, typically comparable to 5+ years.

• Proven expertise in all facets of clinical monitoring.

• Advanced clinical monitoring skills.

• In-depth 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.

• Capability to assess medical research data.

• Proficient knowledge of medical terminology.

• Exceptional oral and written communication abilities.

• Strong customer focus.

• Excellent interpersonal, organizational, and time management skills.

• High attention to detail.

• Adaptability and flexibility.

• Effective presentation skills.

• Good digital literacy and proficient use of Microsoft Office.

• Ability to work in an office, laboratory, clinical, and/or home office setting.

• Frequent travel to site locations, generally 60–80%, with potential extended overnight stays.

• Capability to stand and/or remain stationary for 6–8 hours a day.

• Frequent mobility.

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

• Regular and consistent attendance.

🏝️ Benefits

• Annual incentive plan bonus.

• Comprehensive healthcare.

• Employee benefits.

• Opportunities for career advancement and development.

• Innovative and forward-thinking company culture.