FSP CRA I / CRA II, Multiple Therapeutic Areas

This is a fully remote position, open to applicants in Louisiana, +3 more states.

📋 Description

• Oversee and coordinate all elements of clinical monitoring and site management.

• Perform remote or on-site visits to evaluate compliance with protocols and regulations.

• Manage procedures and guidelines specific to sponsors.

• Utilize a risk-based monitoring approach to oversee investigator sites.

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

• Ensure the accuracy of data through reviews of source documents, source data verification, and CRF assessments.

• Evaluate investigational products through inventory checks and records examination.

• Document findings in reports and correspondence, escalating any deficiencies until resolved.

• Maintain communication with investigative sites between monitoring visits.

• Participate in investigator meetings and manage the investigator payment process.

• Initiate clinical trial sites, conduct trial closeout activities, and retrieve trial materials.

• Ensure all essential documents are complete in accordance with ICH-GCP and relevant regulations.

• Conduct reviews of on-site files.

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

• Update clinical trial systems per study conventions.

• Facilitate communication among 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 in project publications and development tools.

• Contribute to project work and initiatives aimed at process improvement.

⛳️ Requirements

• Bachelor's degree in a life sciences field or a Registered Nursing certification, or equivalent relevant 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.

• Consideration of equivalency through a combination of relevant education, training, and/or experience may be applicable.

• Proven abilities in clinical monitoring.

• Understanding of medical and therapeutic areas, along with medical terminology.

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

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

• Ability to manage Risk-Based Monitoring concepts and processes effectively.

• Excellent oral and written communication skills.

• Strong organizational and time management abilities.

• Effective interpersonal skills and attention to detail.

• Flexibility and adaptability in various situations.

• Capability to work both independently and collaboratively within a team.

• Proficient in Microsoft Office and capable of learning relevant software.

• Strong English language and grammar proficiency.

• Good presentation skills.

• Availability for frequent travel, generally 60–80%, including potential extended overnight stays.

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

🏝️ Benefits

• Fully remote work arrangement.

• Frequent travel, generally 60–80%.

• Exposure to biological fluids with a potential risk of infectious organisms.

• Access to personal protective equipment such as eyewear, garments, and gloves.