Clinical Research Associate

The employer is a global medical device company specializing in minimally invasive targeted tumor treatment technologies and interventional oncology clinical studies. The Clinical Research Associate will coordinate study activities, support and monitor clinical research sites, maintain documentation and data quality, and ensure compliance with protocols, GCP, regulations, and patient safety requirements.

Responsibilities

Coordinate clinical study activities throughout the study lifecycle, from site selection and activation through study close-out

Conduct and/or support site initiation, monitoring, and closeout activities in accordance with the monitoring plan, including review of source documentation, informed consent, investigational device accountability, and protocol compliance, as applicable

Maintain ongoing communication with clinical research sites and investigators, and follow up on study-related issues, queries, and documentation

Monitor site performance and enrollment activities, identify potential risks or barriers, and escalate issues as appropriate to ensure timely study execution

Review patient eligibility, informed consent, and study requirements, as applicable, to support compliance with the protocol and applicable regulatory requirements

Train site staff on protocol requirements, source documentation, and CRF completion, and provide ongoing training and clarification as needed throughout the study

Work collaboratively with the Clinical Operations team, CRO, Data Management, Regulatory, Quality, Safety, and other cross-functional stakeholders to ensure effective study execution, timely resolution of issues, and achievement of study milestones

Prepare and maintain essential clinical study documentation in accordance with the protocol, SOPs, and applicable regulatory requirements

Support data collection, cleaning, and resolution of missing or inconsistent data

Maintain the Trial Master File, regulatory site files, and clinical data systems

Ensure study documentation is complete, accurate, and inspection-ready

Prepare and maintain study trackers, monitoring reports, follow-up letters, action-item logs, and other clinical study records

Ensure clinical studies are conducted in compliance with protocols, SOPs, ICH-GCP, and applicable U.S. regulations

Identify, document, and report adverse events, serious events, device-related issues, and customer complaints, as required

Identify protocol deviations, non-compliance, and quality issues, and ensure appropriate escalation and documentation

Support study readiness for monitoring, audits, and regulatory inspections

Coordinate investigational devices and clinical trial materials, including ordering and tracking

Preferred

Experienced in oncology or other cancer-related clinical research

Experienced with investigational medical devices or minimally invasive procedures

Experienced working with other CRAs

Familiarity with clinical data systems and electronic study documentation

Oncology clinical research

Investigational medical devices

Minimally invasive procedures

Clinical data systems

Electronic study documentation

Benefits

Remote work arrangement in the United States

Company

MedTech and life sciences recruiting firm

Cardiff-by-the-Sea, CA, US

https://www.tetheredtalent.com/

Founded in 2025

2-10 employees

Qualifications

Bachelor's degree in a scientific, clinical, healthcare, or engineering-related field

3+ years of experience as a Clinical Research Associate or in a closely related clinical research role

GCP training and hands-on clinical research experience

Experienced in the medical device industry, including familiarity with medical device terminology and clinical research practices

Experienced working directly with clinical research sites, investigators, and study teams

Strong understanding of clinical research processes and documentation

Strong verbal and written communication skills

Strong teamwork and collaboration skills, with the ability to work effectively with cross-functional teams and build positive relationships with clinical sites and investigators

Excellent organization, attention to detail, and ability to manage multiple study activities

Proficiency in Microsoft Office, particularly Word, Excel, and PowerPoint

Willingness and ability to travel regularly to clinical research sites

Experienced in oncology or other cancer-related clinical research

Experienced with investigational medical devices or minimally invasive procedures

Experienced working with other CRAs

Familiarity with clinical data systems and electronic study documentation

3+ years of experience as a Clinical Research Associate or in a closely related clinical research role.

Required skills

Clinical Practice (GCP), Clinical Research Processes and Documentation, Medical Device Clinical Research, Clinical Research Site Management, Microsoft Office, Oncology Clinical Research, Investigational Medical Devices, Clinical Data Systems

Preferred skills

Verbal and Written Communication, Teamwork and Collaboration

Experience

3+ years