Clinical Research Associate

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.

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

- 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)

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.
Lycia and other biotech companies have recently noticed an increase in email and social media scams targeting job candidates in our industry. Please note Lycia will post any legitimate job openings directly on our website or through our recruitment partner, Lever. If you wish to verify the legitimacy of a job opening, you may contact us.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans.

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.