Senior Clinical Research Associate - Oncology

Must be located in Florida.

JOB SUMMARY:

As a Senior Clinical Research Associate (SrCRA) specializing in Oncology, you will play a crucial role in overseeing site monitoring and management for client-sponsored studies. Your expertise will ensure adherence to ICH GCP guidelines, local regulations, and client standard operating procedures (SOPs). You will interact with investigator site personnel both on-site and remotely, documenting all interactions in the Clinical Trial Management System (CTMS). This role requires collaboration with diverse clinical study teams to efficiently meet study goals while also managing oversight activities in conjunction with CRO partners.

KEY RESPONSIBILITIES:

Site Management and Monitoring Activities:
• Conduct comprehensive site management activities to guarantee compliance with the study protocol, monitoring plan, ICH GCP, local regulations, and client SOPs.
• Execute site qualification, initiation, interim, and close-out visits through both in-person and remote methodologies.
• Collaborate with Clinical Trial Liaison (CTL) and other interdisciplinary teams, such as Study Start-Up and Trial Optimization, to facilitate site activation and ensure the timely achievement of deliverables.
• Build and sustain productive, professional relationships with site staff, fostering effective communication and addressing challenges throughout study execution.
• Ensure drug accountability and proper reconciliation, as well as manage protocol compliance regarding storage and shipment of study medications.

Oversight Monitoring:
• Compile and maintain the Oversight Monitoring Plan to ensure the integrity of study execution.
• Review key study metrics and assess the performance of CRO Clinical Research Associates (CRAs) and investigator sites to identify candidates for oversight monitoring visits.
• Conduct Oversight Monitoring Visits, independently or alongside CRO CRAs, to review site documentation and ensure accurate data capture in line with ALCOA principles.
• Provide status updates regarding study conduct at investigator sites, ensuring prompt follow-up on identified issues or action items.

Documentation and Reporting:
• Maintain current site regulatory files, ensuring timely submission of all required study documentation, including safety reporting.
• Draft and submit precise monitoring visit reports, oversight monitoring reports, and correspondence in a timely manner.
• Regularly verify the completeness of site documentation, including the investigator site file and regulatory binder contents.

Issue Management and Escalation:
• Identify, document, and escalate any protocol deviations or non-compliance issues, resolving study-related challenges as necessary.
• Track, analyze, and report issues, escalating to relevant teams when applicable.

Collaboration and Communication:
• Maintain ongoing communication with site staff, study teams, CTLs, Central Monitors, and CRO CRAs to promote a collaborative environment.
• Engage in team meetings and contribute to process improvement initiatives aimed at enhancing study outcomes.

Inspection Readiness:
• Support inspection readiness efforts, ensuring that sites maintain data integrity and fulfill protocol expectations.

JOB REQUIREMENTS:

Education:

Bachelor's degree (or equivalent)

Experience:
• A minimum of 5 years of hands-on onsite monitoring/CRA experience in a CRO or pharmaceutical environment.
• Required experience in Phase I Oncology monitoring.
• Strong analytical problem-solving skills paired with critical thinking abilities.
• Proficient knowledge of the clinical drug development lifecycle, ICH GCP guidelines, and pertinent regulatory requirements (e.g., FDA, EMA, PMDA).

Skills:
• Exceptional communication and interpersonal skills for fostering relationships internally and externally.
• Familiarity with medical terminology and competence in IT applications including Microsoft Office, EDC, CTMS, and data repositories.
• Proven ability to produce clear and concise written reports.
• Effective prioritization and time management skills.

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EEO Disclaimer: Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.