Clinical Research Associate

W2 Contract

Salary Range: $176,800 - $197,600 per year

Location: Bethesda, MD - Hybrid/Remote Role

Job Summary:

As a Clinical Research Associate, you will assist in managing the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, and company SOPs/ study protocols and to ensure timelines and metrics are met and maintained throughout the study. You will also provide support in the oversight and management of vendors.

Duties and Responsibilities:

• Ensure coordination of interim and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study.
• Perform regulatory document review and monitor adherence to the regulatory document collection process.
• Able to write clinical monitoring plans, source documents, and create other study tools when requested.
• Conduct monitoring activities for interim site monitoring and closeout visits conforming with all relevant laws, regulations, guidelines, protocols, and internal SOPs/policies.
• Identify and effectively document site findings with an equal ability to re-train, place corrective action in place with the site, and follow up as required.
• Verify that study documents (e.g. case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
• Reconcile clinical supplies and drug accountability records at study sites.
• Identify and effectively document site findings with an equal ability to re-train, place corrective action in place with the site, and follow up as required.
• Review, clarify, and obtain data changes via query resolutions with site personnel; collaborate with data management to resolve queries.
• Prepare telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to wholly and accurately document site status and activities.
• Understand and implement processes for distributing and tracking SAEs, safety documentation, and pregnancies. Monitor compliance with these processes.
• Facilitate investigator site payments, as applicable.
• Review, create, and track trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation.
• Obtain a complete understanding of all trial-related documents and operational procedures.
• Maintain clinical trial tracking information about the study, e.g., monitoring calendar, reports, and phone contacts.
• Assist with auditing study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation).
• Review and track study documents (including project files), both electronically and in the Trial Master File and Project Status Reports.
• Communicate and interact with relevant study personnel; develop and maintain collaborative relationships to manage study issues and support milestone achievement; convey project information and answer study questions in a timely manner while using discretion when to escalate to study management; troubleshoot and follow up on study progress, and reviews report data for completeness and accuracy.
• Assist with effective and timely audit and inspection responses and prepare key reports and documents on the study's progress for the study manager.
• Track study-specific tasks and the progress of the trial.
• Review study and site-specific ICF(s) for compliance with ICH/GCP and company SOPs.

Requirement and Qualifications:

• Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs.
• Experience working in phase 1 Oncology studies
• Preferred experience working with NCI
• Strong knowledge of ICH/GCP Guidelines and EDC process.
• Able to establish rapport with site personnel and colleagues

Desired Skills and Experience

Oncology, Phase 1, ICH/GCP Guidelines, SOPs, National Cancer Institute, travel

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