Clinical Research Associate – Level I/II, FSP, Multi Therapeutics

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 evaluations to ensure adherence to protocols and regulatory standards.

• Manage necessary documentation and guarantee readiness for audits.

• Supervise investigator sites utilizing a risk-based monitoring methodology.

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

• Ensure data integrity by reviewing source documents, verifying source data, and examining CRFs.

• Evaluate investigational products through inventory checks and records assessments.

• Record findings in reports and letters, escalating any deficiencies to clinical management.

• Maintain communication with investigative sites between monitoring visits and ensure resolution of any issues.

• Participate in investigator meetings.

• Collaborate daily with sponsor staff and other team members.

• Qualify and initiate clinical trial sites in partnership with the client organization.

• Conduct trial close-out procedures and retrieve trial materials.

• Ensure that essential documents are complete and conduct on-site file evaluations.

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

• Update study systems, such as the Clinical Trial Management System.

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

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

• Complete expense reports and timesheets.

• Assist with project publications and tools, contributing innovative ideas.

• Participate in initiatives aimed at process improvement.

⛳️ Requirements

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

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

• Valid driver's license where applicable.

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

• Demonstrated clinical monitoring capabilities.

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

• Customer-oriented with strong listening skills and attention to detail.

• Strong organizational and time management abilities.

• Effective interpersonal communication skills.

• Adaptability and flexibility in work approach.

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

• Proficiency in Microsoft Office and capability to learn relevant software.

• Strong English language skills, including grammar.

• Effective presentation abilities.

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

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Flexible working arrangements.

• Supportive and inclusive work environment.