Experienced Clinical Research Associate – CRA II/Sr CRA

This is a fully remote position, open to applicants in Kansas, +4 more states.

📋 Description

• Execute and coordinate clinical monitoring and site management tasks.

• Carry out remote and on-site visits to evaluate compliance with protocols and regulations.

• Manage sponsor procedures and guidelines across various monitoring settings.

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

• Maintain audit readiness and foster collaborative relationships with investigational sites.

• Monitor investigator sites utilizing risk-based monitoring techniques, including root cause analysis and corrective/preventive actions.

• Ensure data integrity by reviewing source documents, performing source data verification, and checking CRFs.

• Evaluate investigational products through physical inventory and review of records.

• Document findings in reports and correspondence, escalating deficiencies to clinical management.

• Stay in contact with investigative sites between monitoring visits and follow up on issues until resolved.

• Engage in investigator payment processes and participate in investigator meetings.

• Identify potential investigators and initiate clinical trial sites.

• Conduct trial closeout and retrieve trial materials.

• Ensure that essential documents are complete and perform on-site file reviews.

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

• Update study systems such as Clinical Trial Management Systems.

• 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/tools and contribute to process improvement initiatives.

⛳️ Requirements

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

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

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

• Valid driver's license where applicable.

• Demonstrated clinical monitoring skills.

• Knowledge of medical/therapeutic areas and medical terminology.

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

• Critical thinking skills along with the ability to conduct root cause analysis and problem-solving.

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

• Strong oral and written communication abilities.

• Excellent organizational and time management skills.

• Effective interpersonal skills with a keen attention to detail.

• Flexibility and adaptability to changing situations.

• Ability to work independently or as part of a team.

• Proficient in Microsoft Office with the ability to learn relevant software.

• Good command of the English language and grammar.

• Strong presentation skills.

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

• Willingness to travel frequently, typically 60–80% of the time.

• Ability to use necessary personal protective equipment and work with potential exposure to biological fluids and infectious organisms.

🏝️ Benefits

• Frequent travel requirements, generally 60–80%, with possible extended overnight stays.

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.