Field Clinical Research Associate (Field CRA)

Job Summary

We are seeking an experienced and detail-oriented Field Clinical Research Associate (CRA) to support the execution and oversight of clinical trials at investigative sites. The Field CRA will be responsible for monitoring clinical studies, ensuring protocol compliance, maintaining data quality, and supporting sites throughout the study lifecycle.

The ideal candidate will have hands-on experience with clinical site monitoring, Google Cloud Platform, ICH guidelines, clinical trial protocols, and site management within a pharmaceutical, biotechnology, or CRO environment.

Key Responsibilities

• Conduct on-site and remote monitoring visits including Site Qualification Visits (SQV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV).
• Ensure clinical sites are conducting studies in accordance with the protocol, ICH-Google Cloud Platform, SOPs, and applicable regulatory requirements.
• Review source documentation, clinical data, informed consent forms, and essential documents for accuracy and completeness.
• Perform Source Data Verification (SDV) and Source Data Review (SDR) as required.
• Identify, document, and follow up on protocol deviations, data discrepancies, compliance issues, and other site-related risks.
• Work closely with Principal Investigators, study coordinators, and site staff to resolve study-related issues.
• Monitor investigational product (IP) accountability, storage, handling, and reconciliation where applicable.
• Review and track Essential Documents and Trial Master File (TMF) documentation.
• Support site activation, enrollment, retention, and study close-out activities.
• Conduct regular communication with clinical sites and provide training and guidance on study procedures.
• Prepare monitoring visit reports and follow-up letters within required timelines.
• Escalate significant risks, compliance concerns, and study issues to the Clinical Trial Manager or project team.
• Support the identification and implementation of corrective and preventive actions (CAPA) when required.
• Collaborate with Clinical Operations, Data Management, Medical Affairs, Safety, Regulatory, and other cross-functional teams.
• Maintain accurate study documentation and ensure timely completion of assigned clinical trial activities.
• Travel to clinical research sites as required by the study.

Required Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Healthcare, or a related field.
• 2–5+ years of clinical research experience, preferably with direct CRA/site monitoring experience.
• Hands-on experience conducting clinical trial monitoring visits.
• Strong knowledge of ICH-Google Cloud Platform, FDA regulations, clinical research processes, and applicable SOPs.
• Experience with clinical trial protocols and essential clinical documentation.
• Understanding of SDV/SDR, source documentation, protocol deviations, and investigational product accountability.
• Strong written and verbal communication skills.
• Excellent organizational and time-management skills.
• Ability to work independently while effectively collaborating with cross-functional teams.
• Willingness and ability to travel to clinical sites as required.

Preferred Qualifications

• Previous experience as a Field CRA, Clinical Research Associate, Clinical Research Monitor, or Site Monitor.
• Experience supporting Phase I–IV clinical trials.
• Experience working within a pharmaceutical, biotechnology, medical device, or CRO environment.
• Experience with EDC, CTMS, eTMF, and other clinical trial systems.
• Therapeutic area experience such as oncology, cardiovascular, CNS, immunology, infectious disease, or rare diseases.
• Experience with risk-based monitoring and centralized/remote monitoring approaches.
• Strong knowledge of FDA/EMA and other applicable regulatory requirements.