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Clinical Research Associate

Job not on LinkedIn

🔥 25 minutes ago

🏄 California – Remote

infoinfo

💵 $125k - $150k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

Where this job comes from

Posted on Lycia Therapeutics's careers page, not through a job board

First seen by Remote Rocketship 25 minutes ago

Logo of Lycia Therapeutics

Lycia Therapeutics

11 - 50 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

💰 $70M Series B on 2021-09

Biotechnology • Healthcare • Pharmaceuticals

Lycia Therapeutics is a Series B biotech company building upon the novel platform developed by academic founder Professor Carolyn Bertozzi at Stanford University. It specializes in creating LYTAC (lysosomal targeting chimera) protein degraders, which utilize the cell’s lysosomal trafficking and degradation pathway to target both soluble and membrane-bound extracellular proteins. The LYTAC platform aims to tackle challenging membrane proteins, clear pathogenic immune complexes in circulation, and deplete antibodies to specific antigens, potentially providing innovative therapeutics for cancer and autoimmune diseases.

📋 Description

• 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 • Maintain the electronic Trial Master File (eTMF) • Review data and findings in Electronic Data Capture systems • Write, track, and follow up on clinical data queries with site personnel • Support traveling CRAs through remote monitoring activities • Track site key performance indicators and update Clinical Trial Management Systems • Ensure trial conduct aligns with GCP, ICH guidelines, FDA/local regulations, and study-specific 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 via remote monitoring tools • Review source documents, medical records, and Case Report Forms to verify data accuracy, completeness, and integrity • Identify, document, and track protocol deviations, adverse events, and data queries • Work with site investigators to implement corrective and preventive actions • Check investigational product accountability, storage, dispensing, and return • Maintain comprehensive Trial Master File documents • Write detailed monitoring visit reports within required timelines • Train investigators and clinical research coordinators 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, such as Clinical Research Coordinator, clinical data assistant, or junior CRA experience • 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 for co-monitoring, up to 30% travel

🏖️ Benefits

• Annual bonus • Equity • Generous benefits package

Apply Now

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