Senior Clinical Research Associate – Early Development

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

📋 Description

• Assist in monitoring and managing site activities for studies sponsored by clients.

• Execute site qualification, initiation, interim, and close-out visits, both in-person and remotely.

• Collaborate with the Clinical Trial Liaison and client departments to facilitate site activation and achieve deliverables.

• Build and nurture relationships with investigator site personnel.

• Oversee drug accountability, reconciliation, and destruction processes.

• Develop and uphold the Oversight Monitoring Plan.

• Analyze study metrics and evaluate the performance of CRO CRAs and investigator sites.

• Independently conduct oversight monitoring visits or alongside CRO CRAs.

• Examine source documentation and ensure precise data capture in alignment with ALCOA principles.

• Communicate the status of study conduct and address issues and action items.

• Maintain site regulatory documentation and confirm timely submission of study materials, including safety reports.

• Draft monitoring visit reports, oversight monitoring visit reports, and study-related correspondence.

• Identify, log, track, trend, and escalate protocol deviations and study-related challenges.

• Maintain communication with site staff, study teams, CTLs, Central Monitors, and CRO CRAs.

• Engage in team meetings and initiatives aimed at process enhancement.

• Assist with inspection readiness activities to ensure data integrity and adherence to protocol deliverables.

⛳️ Requirements

• Bachelor's degree or equivalent qualification.

• At least 5 years of relevant experience for Senior CRA position.

• Strong analytical and problem-solving skills along with critical thinking capabilities.

• Knowledge of the clinical drug development process, ICH GCP guidelines, and relevant regulatory standards (e.g., FDA, EMA, PMDA).

• Excellent communication and interpersonal abilities for fostering relationships both internally and externally.

• Familiarity with medical terminology.

• Proficient in Microsoft Office, EDC, CTMS, and data repositories.

• Proven ability to produce clear and concise written reports.

• Strong prioritization and time management skills.

🏝️ Benefits

• Equal opportunity employer.

• Consideration without regard to legally protected status.