[Hiring] Clinical Research Associate @Lycia Therapeutics

Role Description

The Clinical Research Associate is responsible for monitoring clinical trial sites to ensure that studies are conducted ethically, safely, and in full compliance with the trial protocol, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements. The CRA will act as the primary bridge between Lycia and the clinical research sites.

Key Responsibilities

• Site Management and Support: Assist with investigator recruitment, site selection activities, study startup, and close-out tasks. Provide ongoing operational support to investigative sites via phone and email.
• Document & Regulatory Tracking: Collect, review, and track essential regulatory documents and Investigator Site Files (ISF) to ensure audit and inspection readiness. Maintain the electronic Trial Master File (eTMF).
• Data and Query Management: Review data points and findings within Electronic Data Capture (EDC) systems. Write, track, and follow up on clinical data queries with site personnel.
• Remote Monitoring & Collaboration: Support traveling CRAs by conducting remote monitoring activities, tracking site key performance indicators (KPIs), and updating Clinical Trial Management Systems (CTMS).
• Compliance & Escalation: Ensure trial conduct aligns with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, FDA/local regulations, and study-specific standard operating procedures (SOPs). Escalate site non-compliance or protocol deviations to Clinical Operations Management.

Clinical Research Site Oversight

• Site Monitoring Visits: Conduct qualification, site initiation, interim monitoring, and close-out visits in person or via remote monitoring tools.
• Data Verification: Review source documents, medical records, and Case Report Forms (CRFs/EDC) to verify data accuracy, completeness, and integrity.
• Protocol & Regulatory Compliance: Ensure site staff adhere to the study protocol, ICH-GCP guidelines, FDA regulations, and standard operating procedures (SOPs).
• Issue Escalation: Identify, document, and track protocol deviations, adverse events, and data queries, working with site investigators to implement corrective and preventive actions (CAPA).
• Investigational Product (IP) Management: Check accountability, storage, dispensing, and return of investigational drugs or devices at study sites.
• Documentation & Reporting: Maintain comprehensive Trial Master File (TMF) documents and write detailed monitoring visit reports (trip reports) within required timelines.
• Site Support & Training: Train investigators and clinical research coordinators (CRCs) on study protocols, electronic data capture systems, and regulatory requirements.

Qualifications

• Education: Bachelor’s or advanced degree in a life science, nursing, pharmacy, or health-related field.
• Experience: 2+ years of clinical research experience (e.g., prior experience as a Clinical Research Coordinator, clinical data assistant, or junior CRA).
• Regulatory Knowledge: Deep understanding of ICH-GCP guidelines, FDA regulations, EU, and local ethics/IRB processes.
• Technical Skills: Proficiency with Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and remote data review tools.

Requirements

• Strong attention to detail and problem-solving skills.
• Effective verbal and written communication.
• High level of organization and time management.
• Ability and willingness to travel to assigned clinical trial sites or co-monitoring (up to 30% travel).

Benefits

• Expected base salary range: $125,000 - $150,000 a year.
• Compensation based on experience, qualifications, and internal equity.
• Competitive employment package including an annual bonus, equity, and a generous benefits package.

Company Description

Lycia Therapeutics (Nasdaq: LYCA) is a clinical-stage biotechnology company using its proprietary lysosomal targeting chimera (LYTAC) platform to discover and develop therapeutics that degrade extracellular and membrane-bound proteins. These proteins drive a wide range of difficult-to-treat diseases, including autoimmune, inflammatory, and allergic conditions. Lycia was established in 2019 in collaboration with academic founder and Nobel Laureate Carolyn Bertozzi, Ph.D., professor of chemistry and HHMI investigator at Stanford University. Lycia is headquartered in South San Francisco.