Senior Clinical Research Associate

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

📋 Description

• The Senior CRA is essential in aiding the clinical operations team throughout the execution of clinical trials.

• This role primarily emphasizes trial preparation, site monitoring, data quality management, as well as study tracking and reporting.

• Conduct regular monitoring visits to guarantee that the trial complies with the protocol and maintains subject safety, verifying data accuracy through thorough Source Document Verification (SDV).

• Ensure that investigational products, biological samples, and study supplies are managed according to relevant requirements, including receipt, storage, return, destruction, and accountability.

• Maintain the electronic and/or paper Trial Master File (TMF) to ensure adherence to proper documentation standards and perform tasks independently.

• Assist in the creation, distribution, management, and archiving of critical clinical trial documents.

• Support the preparation and upkeep of study-related materials, including but not limited to site and CRA training materials, regulatory document templates, study binders, study plans, communication records, and presentation materials.

• Facilitate training activities for clinical research teams and site personnel.

• Aid in the implementation and management of site-related contracts.

• Support the review of vendor and site contract terms and verify associated invoices for precision and compliance with the budget.

• Ensure that all responsibilities are executed in accordance with company regulations, safety policies, and standard operating procedures (SOPs).

• Oversee all operational aspects of clinical trials, from Study Start-up through Database Lock.

• Ensure that all activities align with stated goals, timelines, budgets, and strictly conform to applicable regulatory requirements, ICH/GCP, and SOP standards.

• Provide sponsor oversight of the CRO activities for the Global Phase 3 trial.

• Manage and oversee all study-related vendors, including Contract Research Organizations (CROs) and Contract Labs.

• Review and provide feedback on vendor contracts and Statements of Work (SOWs).

• Assist with invoice reconciliation and financial tracking as necessary.

• Act as the primary contact for key vendors and stakeholders, managing and coordinating parties to effectively resolve issues.

• Investigational Product (IP) Management: Oversee the Investigational Product (IP).

• Review protocol deviations and data listings as required to ensure sponsor oversight.

• Assist in the formulation of internal SOPs and processes to ensure continued compliance and readiness for inspection.

• Build and sustain strong relationships and trust with investigators and other stakeholders.

• Execute activities to ensure that investigators and stakeholders have the pertinent information/knowledge to conduct the studies as requested by the company.

• Provide necessary on-site assistance and guidance to trial centers (sites) to support their execution of Photoimmunotherapy (PIT), assuming a role akin to that of a Field Clinical Technician (FCT) when needed.

• Perform other duties as mutually agreed upon between the candidate and the company.

⛳️ Requirements

• Bachelor's degree or equivalent in the life sciences or a related field.

• A minimum of 3 years of relevant industry experience with a large company or 5 years with a smaller company.

• Previous experience in oncology (preferably head and neck cancer) and/or combination drug-device studies is advantageous.

• Strong organizational and project management abilities, including the capacity to multitask and manage/track information.

• Positive, service-oriented, and professional in all interactions.

• Proactive in recognizing issues as they arise, with resolution and/or appropriate escalation to management as necessary.

• Excellent interpersonal, written, and verbal communication skills.

• Self-motivated and capable of working independently with minimal supervision.

• Detail-oriented.

• Strong computer skills and a high level of proficiency with Microsoft Office (e.g., Word, Excel, PowerPoint, MS Project or other timeline management tools, Outlook) and Adobe Acrobat programs.

• Willingness and ability to travel up to 60% nationally and internationally, depending on trial activities.

🏝️ Benefits

• Flexible time off.

• Stock options.

• 401k.

• Medical plans.

• Dental plans.

• Vision plans.