FSP CRA I/II, Gen Med, Respiratory, HIV, Oncology

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

📋 Description

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

• Perform remote and in-person visits to evaluate adherence to protocol and regulatory standards.

• Oversee necessary documentation and ensure preparedness for audits.

• Supervise investigator sites utilizing risk-based monitoring, root cause analysis, critical thinking, and problem-solving techniques.

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

• Evaluate investigational products through physical inventory assessments and records analysis.

• Record observations in reports and letters, escalating deficiencies until resolved.

• Maintain communication with investigative sites between monitoring visits to verify protocol compliance, resolve issues, and ensure timely data entry.

• Execute monitoring tasks in accordance with the approved monitoring plan.

• Take part in investigator payment processes and investigator meetings.

• Interact daily with sponsor staff and other collaborators.

• Work alongside the client company to qualify and initiate clinical trial sites.

• Complete trial closeout and retrieve trial materials as necessary.

• Ensure essential documents are complete and retained in compliance with ICH-GCP and relevant regulations.

• Conduct on-site file reviews following project specifications.

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

• Update study systems, such as 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, timesheets, and other administrative duties.

• Assist with project publications and tools, contributing ideas to the project team.

• Participate in process-improvement initiatives.

⛳️ Requirements

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

• Prior experience demonstrating knowledge, skills, and abilities equivalent to at least 1 year as a clinical research monitor or completion of the PPD Drug Development Fellowship.

• Valid driver's license where applicable.

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

• Knowledge in therapeutic areas such as Respiratory, HIV, and Oncology; preference for Respiratory and HIV.

• Demonstrated clinical monitoring skills.

• Comprehension of medical/therapeutic area knowledge and medical terminology.

• Proficiency in ICH GCPs, relevant regulations, and procedural documents.

• Familiarity with Risk-Based Monitoring concepts and processes.

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

• Excellent oral and written communication skills.

• Customer-oriented with good listening skills, attention to detail, and ability to identify underlying issues.

• Strong organizational and time management skills.

• Interpersonal skills to work effectively with others.

• Flexibility and adaptability in a dynamic work environment.

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

• Proficient in Microsoft Office and ability to learn relevant software.

• Strong English language and grammar skills.

• Presentation skills to convey information effectively.

• Ability to work in office, laboratory, clinical, and/or home-office settings.

• Willingness to travel frequently and drive to site locations.

• Capability to work with potential exposure to biological fluids and infectious organisms.

• Proficient in using necessary personal protective equipment.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday-Friday work schedule.

• Opportunity to collaborate with global pharmaceutical and biotechnology companies.

• Frequent travel, typically 60–80%, including potential extended overnight stays.