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About the Role

The Clinical Research Associate (CRA) is responsible for monitoring clinical trial sites to ensure ethical, safe, and compliant study conduct. The CRA serves as the primary liaison between Lycia and clinical research sites.

Responsibilities

Assist with investigator recruitment, site selection, study startup, and close-out tasks.
Provide ongoing operational support to investigative sites via phone and email.
Collect, review, and track essential regulatory documents and Investigator Site Files (ISF).
Maintain the electronic Trial Master File (eTMF).
Review data points and findings within Electronic Data Capture (EDC) systems.
Write, track, and follow up on clinical data queries with site personnel.
Conduct remote monitoring activities, track site key performance indicators (KPIs), and update Clinical Trial Management Systems (CTMS).
Ensure trial conduct aligns with Good Clinical Practice (GCP), ICH guidelines, FDA/local regulations, and study-specific SOPs.
Escalate site non-compliance or protocol deviations to Clinical Operations Management.
Conduct qualification, site initiation, interim monitoring, and close-out visits in person or remotely.
Review source documents, medical records, and Case Report Forms (CRFs/EDC) to verify data accuracy, completeness, and integrity.
Ensure site staff adhere to the study protocol, ICH-GCP guidelines, FDA regulations, and SOPs.
Identify, document, and track protocol deviations, adverse events, and data queries.
Work with site investigators to implement corrective and preventive actions (CAPA).
Check accountability, storage, dispensing, and return of investigational drugs or devices at study sites.
Maintain comprehensive Trial Master File (TMF) documents.
Write detailed monitoring visit reports (trip reports) within required timelines.
Train investigators and clinical research coordinators (CRCs) on study protocols, EDC systems, and regulatory requirements.

Requirements

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

Skills

ICH-GCP guidelines
FDA regulations
EU and local ethics/IRB processes
Electronic Data Capture (EDC) systems
Clinical Trial Management Systems (CTMS)
Remote data review tools
Attention to detail
Problem-solving
Verbal communication
Written communication
Organization
Time management

Location

South San Francisco

Work Type

Onsite
Remote Monitoring

Experience Level

2+ years

Education Level

Bachelor's degree
Advanced degree

Salary/Compensations

$125,000 - $150,000

Benefits

Annual bonus
Equity
Generous benefits package

About the Company

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.
Visit https://lyciatx.com/ for more information.

Equal Opportunity

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.