Clinical Research Associate

Clinical Research Associate

Location: South San Francisco, California
Work Arrangement: Remote
Employment Type: Full-Time
Salary: $125,000–$150,000 annually
Travel: Up to 30%

Job Description

About Lycia Therapeutics

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. In October 2026, Lycia completed an initial public offering, and its common stock now trades on the Nasdaq Global Select Market under the ticker symbol LYCA. Lycia is headquartered in South San Francisco.

The Role

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

In-House

• 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 and 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 and Collaboration: Support traveling CRAs by conducting remote monitoring activities, tracking site key performance indicators (KPIs), and updating Clinical Trial Management Systems (CTMS).

• Compliance and Escalation: Ensure trial conduct aligns with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, FDA and 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 and 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 Management: Check accountability, storage, dispensing, and return of investigational drugs or devices at study sites.

• Documentation and Reporting: Maintain comprehensive Trial Master File (TMF) documents and write detailed monitoring visit reports (trip reports) within required timelines.

• Site Support and Training: Train investigators and clinical research coordinators (CRCs) on study protocols, electronic data capture systems, and regulatory requirements.

Required Qualifications and Skills

• Education: Bachelor's or advanced degree in a life science, nursing, pharmacy, or health-related field.

• Experience: At least two years of clinical research experience, such as previous experience as a Clinical Research Coordinator, clinical data assistant, or junior CRA.

• Regulatory Knowledge: Deep understanding of ICH-GCP guidelines, FDA regulations, EU requirements, and local ethics/IRB processes.

• Technical Skills: Proficiency with Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and remote data review tools.

Core Competencies

• 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 participate in co-monitoring activities, with up to 30% travel.

Compensation and Benefits

• Base Salary: $125,000–$150,000 annually.

• Annual Bonus.

• Equity Compensation.

• Generous Benefits Package.

Compensation will depend on experience, qualifications, and internal equity. Lycia encourages candidates at different experience levels to apply, as there may be flexibility in job title and responsibilities.

Additional Information

Lycia Therapeutics is an equal opportunity employer and values diversity. The company does not discriminate based on protected characteristics.

Lycia cautions applicants about fraudulent emails and social media messages targeting biotechnology job candidates. Legitimate job openings are posted directly on the company's website or through its recruitment partner, Lever. Applicants may contact Lycia to verify a job opening's legitimacy.

Artificial Intelligence in Hiring

Lycia may use artificial intelligence tools to assist with portions of the hiring process, including reviewing applications, analyzing resumes, assessing responses, and identifying potential inconsistencies or verification signals in application materials. These tools support the recruitment team but do not replace human judgment. Final hiring decisions are made by humans. Applicants may contact the company for additional information about how their data is processed.