FSP CRA I/II

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

📋 Description

• Execute and oversee clinical monitoring and site management tasks for a designated sponsor.

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

• Manage essential documentation and ensure readiness for audits.

• Ensure that trials comply with approved protocols, ICH-GCP guidelines, relevant regulations, and SOPs.

• Safeguard the rights and well-being of participants while ensuring the reliability of data.

• Build collaborative relationships with investigational sites.

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

• Employ root cause analysis, critical thinking, and problem-solving to detect process failures and implement corrective/preventive measures.

• Ensure data integrity through source document review, source data verification, and CRF evaluation.

• Evaluate investigational products via inventory and records assessment.

• Document findings in reports and letters, escalating issues until resolved.

• Maintain communication with investigative sites between monitoring visits.

• Take part in investigator payment processes and meetings.

• Engage daily with sponsor personnel and complementary staff.

• Initiate, manage, and close clinical trial sites in partnership with the client.

• Retrieve trial materials and ensure that all essential documentation is complete and compliant.

• Conduct on-site file assessments.

• Provide trial status tracking and updates to the Clinical Team Manager.

• Update study systems, including the Clinical Trial Management System.

• Facilitate communication among investigative sites, the client company, and the PPD project team.

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

• Complete expense reports and timesheets.

• Assist with project publications and tools.

• Contribute to project initiatives and enhance processes.

⛳️ Requirements

• Bachelor's degree in a life sciences discipline, or Registered Nursing certification or equivalent formal academic/vocational qualification.

• Minimum of 1 year of experience as a clinical research monitor, or completion of the PPD Drug Development Fellowship.

• Equivalence through a combination of relevant education, training, and/or directly related experience may be considered.

• Valid driver's license, where applicable.

• Demonstrated clinical monitoring expertise.

• Knowledge of medical/therapeutic areas and medical terminology.

• Familiarity with ICH GCPs, relevant regulations, and procedural documents.

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

• Capability to manage Risk-Based Monitoring concepts and processes.

• Excellent verbal and written communication skills, including interactions with medical personnel.

• Customer-focused with strong listening abilities and attention to detail.

• Strong organizational and time management skills.

• Effective interpersonal skills.

• Adaptability and flexibility.

• Ability to work independently as well as collaboratively in a team.

• Proficiency in Microsoft Office and aptitude for learning relevant software.

• Strong English language and grammar skills.

• Good presentation skills.

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

• Ability to work in settings that may expose one to biological fluids and infectious organisms.

• Capability to use necessary personal protective equipment, including eyewear, garments, and gloves.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Opportunity to collaborate with global pharmaceutical and biotechnology firms.

• Professional engagement in clinical trials across various countries and therapeutic domains.

• Experience related to travel, including site visits and investigator meetings.