Principal CRA

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

📋 Description

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

• Execute remote and on-site monitoring activities utilizing a risk-based monitoring strategy.

• Perform Source Data Review, Source Data Verification, and CRF assessments as needed.

• Evaluate investigational product accountability through inventory checks and record reviews.

• Detect site process challenges and implement corrective and preventive measures.

• Identify, document, escalate, and follow up on site deficiencies and issues until they are resolved.

• Maintain communication with investigational sites between monitoring visits.

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

• Verify that essential study documents are complete, accurate, and maintained in compliance with regulatory standards.

• Conduct on-site file assessments and assist in audit and inspection preparedness.

• Initiate clinical trial sites and assist in site close-out processes.

• Engage in investigator meetings and aid in identifying and assessing potential investigational sites.

• Address requirements from company, sponsor, and regulatory audits and inspections.

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

• Ensure accurate and timely information is maintained in study systems, including CTMS.

• Conduct quality checks on reports generated by CTMS.

• Facilitate communication among sites, sponsors, and project teams.

• Contribute to project tools, communications, publications, process enhancements, and sharing of best practices.

• Support additional study activities such as trip report assessments, newsletters, or leading CRA team meetings.

• Participate in the investigator payment process.

• Accurately complete expense reports and timesheets in a timely manner.

⛳️ Requirements

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

• Minimum of 2+ years of experience as a Clinical Research Monitor / CRA, or comparable relevant experience.

• Valid driver's license, if applicable.

• Equivalent combinations of education, training, and directly related experience may also be considered.

• Strong skills in clinical monitoring and site management.

• Comprehensive understanding and practical application of ICH-GCP, applicable regulations, and clinical research protocols.

• Good knowledge of medical terminology and relevant therapeutic areas.

• Experience implementing Risk-Based Monitoring (RBM) principles and processes.

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

• Excellent attention to detail along with strong organizational and time-management abilities.

• Effective written and verbal communication skills, including the ability to engage confidently with medical professionals and investigational site personnel.

• Strong interpersonal skills and a collaborative, customer-oriented approach.

• Ability to adapt to shifting priorities and work efficiently both independently and as part of a global team.

• Proficient in Microsoft Office and capable of quickly learning clinical trial systems and software.

• Good written and spoken English proficiency.

• Strong presentation skills.

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

• Ability to regularly travel to clinical trial sites.

• Willingness to undertake extended and overnight stays when necessary.

• Compliance with applicable sponsor, client, and investigational site requirements.

🏝️ Benefits

• The opportunity to engage in innovative and diverse global clinical research projects.

• Exposure to a wide range of sponsors, therapeutic areas, and clinical trial environments.

• A collaborative and inclusive culture that values your expertise and ideas.

• Continuous learning, professional development, and opportunities for career advancement.

• Competitive compensation and benefits package.

• Necessary personal protective equipment provided or required for exposure to biological materials.