Bachelor's or advanced degree in life science, nursing, pharmacy, or health-related field.
2+ years of clinical research experience, preferably as a Clinical Research Coordinator or junior CRA.
Deep understanding of ICH-GCP guidelines and FDA regulations.
Proficiency with Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS).
Strong attention to detail, problem-solving skills, and effective communication abilities.
Willingness to travel to clinical trial sites (up to 30%).
Responsibilities
Assist with investigator recruitment, site selection, and study startup tasks.
Collect, review, and track essential regulatory documents for audit readiness.
Review data points in EDC systems and manage clinical data queries.
Conduct remote monitoring activities and track site performance indicators.
Ensure compliance with GCP, ICH guidelines, and escalate non-compliance issues.
Conduct site monitoring visits and verify data accuracy and integrity.
Train site staff on study protocols and regulatory requirements.
Benefits
Annual bonus and equity options.
Generous benefits package including health and wellness programs.
Flexible job title and responsibilities based on experience.
Full Job Description
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 & 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.
Site Support & Training: Train investigators and clinical research coordinators (CRCs) on study protocols, electronic data capture systems, and regulatory requirements.
Required Qualifications & Skills
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.
Core Competencies:
Strong attention to detail and problem-solving skills.
Effective verbal and written communication.
High level of organization and time management.
Travel: Ability and willingness to travel to assigned clinical trial sites or co-monitoring (up to 30% travel)
$125,000 - $150,000 a year
The expected base salary range for this role is $125,000-150,000. We encourage candidates of all levels to apply as there is often flexibility on job title and responsibilities. Compensation will be based on a variety of factors, including experience, qualifications, and internal equity. Lycia offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
