Senior Clinical Research Associate

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Oversee and manage clinical sites to ensure adherence to CFR and ICH/GCP standards.

• Assess, initiate, supervise, and conclude clinical site activities.

• Identify and evaluate potential investigators for participation.

• Conduct pre-study assessments, site initiation, interim monitoring, and close-out visits.

• Support site start-up, review essential documents, and facilitate their collection.

• Provide training to investigators and site personnel on protocols, procedures, documentation, and regulatory obligations.

• Monitor compliance with protocols and GCP guidelines.

• Perform source data reviews and validate clinical data against original documents.

• Ensure prompt data entry and address queries effectively.

• Conduct drug accountability and confirm sufficient drug supply.

• Review documentation regarding research specimens, including their storage, processing, and shipment.

• Collaborate with drug safety teams on reporting serious adverse events.

• Maintain comprehensive and accurate regulatory files for sites and ensure IRB compliance.

• Track and report on study progress, protocol deviations, issue resolutions, and compliance follow-ups.

• Prepare visit reports, confirmation letters, and follow-up correspondence.

• Manage the Clinical Trial Management System (CTMS).

• Address site-related issues and action items or escalate them according to the Clinical Monitoring Plan.

• Assist Data Management and offer co-monitoring support when necessary.

• Participate in quality audits, departmental initiatives, study documentation, and vendor management or data review activities.

• Attend mandatory staff meetings and training sessions.

• Complete required training, timesheets, expense reports, and updates to your CV.

⛳️ Requirements

• Experience in monitoring Phase I clinical trials is mandatory.

• A minimum of 4 years of prior CRA monitoring experience within a CRO or pharmaceutical organization is essential.

• A Bachelor of Arts/Science (BA/BS) degree, or equivalent experience and training, with at least six (6) years in the pharmaceutical/biotech field.

• Proficiency in both written and spoken English is required.

• Proficiency in local languages, where applicable.

• Willingness and capability to travel 55–75% of the time.

• Previous experience with Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and CTMS systems.

• Proficient in Microsoft Office Suite: Word, Excel, PowerPoint, SharePoint.

• Exceptional communication and organizational abilities.

• Ability to engage in discussions regarding scientific, medical, and therapeutic information with healthcare professionals.

• Capable of managing multiple tasks, prioritizing workload, and addressing problems concurrently.

• Flexibility regarding work assignments, learning opportunities, and travel commitments.

• A background as an RN or healthcare professional is preferred.

• Experience in oncology or immunology is preferred.

• Experience with global clinical trials is preferred.

• Readiness for FDA/EMEA inspections is preferred.

🏝️ Benefits

• Full-time employment.

• Equal opportunity employment.