Clinical Research Associate

Lycia Therapeutics•South San Francisco, CA

9d•$125,000 - $150,000

About The Position

The Clinical Research Associate (CRA) monitors clinical trial sites to ensure studies are conducted ethically and safely, and comply with the trial protocol, Good Clinical Practice (GCP), and applicable regulatory requirements. The CRA serves as the primary liaison between Lycia Therapeutics and clinical research sites. The role combines in-house site support and documentation activities with clinical research site oversight. It includes supporting site selection and study startup, maintaining regulatory documentation and the electronic Trial Master File, reviewing clinical data, conducting monitoring visits, and helping sites meet protocol and regulatory requirements. The CRA also identifies and escalates compliance issues and supports site staff through training and follow-up. Lycia Therapeutics is a clinical-stage biotechnology company developing therapeutics using its lysosomal targeting chimera (LYTAC) platform. The company is headquartered in South San Francisco.

Requirements

Bachelor’s or advanced degree in a life science, nursing, pharmacy, or health-related field.
At least 2 years of clinical research experience, such as experience as a Clinical Research Coordinator, clinical data assistant, or junior CRA.
Deep understanding of ICH-GCP guidelines, FDA regulations, and EU and local ethics/IRB processes.
Proficiency with EDC systems, CTMS, and remote data review tools.
Strong attention to detail and problem-solving skills.
Effective verbal and written communication skills.
Strong organization and time-management skills.
Ability and willingness to travel to assigned clinical trial sites or for co-monitoring, up to 30%.

Responsibilities

Assist with investigator recruitment, site selection, study startup, and study close-out activities.
Provide ongoing operational support to investigative sites by phone and email.
Collect, review, and track essential regulatory documents and Investigator Site Files (ISFs), and maintain the electronic Trial Master File (eTMF).
Review clinical data in Electronic Data Capture (EDC) systems and write, track, and follow up on data queries with site personnel.
Support remote monitoring, track site key performance indicators (KPIs), and update Clinical Trial Management Systems (CTMS).
Ensure trial conduct complies with GCP, ICH guidelines, FDA and local regulations, and study-specific standard operating procedures (SOPs).
Escalate site non-compliance and protocol deviations to Clinical Operations Management.
Conduct qualification, site initiation, interim monitoring, and close-out visits in person or using remote monitoring tools.
Review source documents, medical records, and Case Report Forms (CRFs/EDC) to verify data accuracy, completeness, and integrity.
Identify, document, and track protocol deviations, adverse events, and data queries; work with site investigators on corrective and preventive actions (CAPA).
Check investigational product accountability, storage, dispensing, and return at study sites.
Maintain TMF documentation and write detailed monitoring visit reports within required timelines.
Train investigators and clinical research coordinators (CRCs) on study protocols, EDC systems, and regulatory requirements.