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 and 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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