Location - Hybrid role in South San Francisco 3x per week on site

About the Role

A forward-thinking biopharma company specializing in cutting-edge and computational drug discovery is seeking a Senior Clinical Research Associate (Sr CRA) to join their team. Utilizing an advanced platform that integrates molecular interaction visualization, computational chemistry, and data analytics, the organization focuses on developing orally available small molecules that address limitations of biologics and peptides. Their pipeline includes treatments targeting high-need chronic conditions such as cardiovascular, metabolic, and pulmonary diseases.

Backed by seasoned global drug development leaders and premier life sciences investors, the company successfully went public in 2023. They leverage the innovative ecosystems of both regions to drive progress in drug discovery and development.

Role Overview

The Sr CRA will oversee clinical trial operations for small to medium-sized studies or support major studies under guidance. Collaborating with cross-functional teams, vendors, and clinical sites, the Sr CRA ensures trials align with protocols, Good Clinical Practices (GCP), and internal policies. This position reports to a Senior Clinical Trial Manager (Sr CTM). While hybrid work in South San Francisco is preferred, remote options are considered.

Key Responsibilities

• Partner with the project team to execute clinical protocols according to GCP, SOPs, and corporate objectives.
• Support study activities across start-up, enrollment, maintenance, and closeout phases.
• Contribute to protocol creation, amendments, and updates in coordination with medical writing teams.
• Manage study vendors (e.g., IRT, eCOA, cardiac safety) to ensure data quality and timely deliverables.
• Supervise clinical site activities, including contract negotiations and monitoring CRO efforts.
• Ensure adherence to meeting agendas, action items, and accurate documentation.
• Assist with study design implementation and provide operational feedback.
• Support the development of study budgets, timelines, and vendor evaluations.
• Review trial documents like informed consent forms, monitoring plans, and site materials.
• Assist in the preparation of case report forms (CRFs) and oversee user testing and data integrity.
• Monitor drug supply needs and coordinate study-wide logistics.
• Ensure compliance with Trial Master File (TMF) requirements through quality checks.
• Contribute to company initiatives, such as SOP reviews and clinical operations improvements.

Qualifications

Education:

• Bachelor’s degree in a scientific discipline or related field.

Experience:

• At least 4 years of clinical trial management experience in a sponsor, CRO, or CRA role. Global trial exposure is a plus.
• Comprehensive knowledge of clinical trial processes, ICH guidelines, and medical terminology.
• Strong problem-solving, organizational, and communication skills.
• Advanced proficiency with Microsoft Office tools and other relevant applications.

Salary & Benefits

This role offers a competitive annual salary between $110,000 and $130,000, plus bonuses, equity, and benefits. Final compensation will depend on location, experience, and qualifications. Specific salary discussions will take place during the hiring process.