Reporting to the Director, Clinical Monitoring, primarily responsible for the management of clinical sites and monitoring of clinical data at assigned sites
The Senior Clinical Research Associate (Sr. CRA) will independently execute monitoring responsibilities for clinical trials in Phases 1, 2, and 3, in accordance with ICH/GCP guidelines and Standard Operating Procedures (SOPs)
Prepares for and conducts site qualification, site initiation, interim, and closeout monitoring visits
Main point of contact between assigned sites and Sponsor
Conducts all monitoring with a strong focus on data integrity and patient safety, adhering to GCP protocol and sponsor requirements
Delivers high quality and timely reports following each monitoring visit
Completes and submits monitoring-related expense reports in accordance with the company and/or Client’s travel & expense guidelines
Works with the Clinical Operations Manager to identify, escalate, and resolve issues at assigned clinical sites
Maintains Trial Master File (TMF)/Electronic Trial Master File (eTMF) for assigned sites
Manages query resolution process with clinical sites and data management groups
Travel of up to 75% may be required, including globally
Quarterly travel to San Diego headquarters required, if not residing locally.

Requirements

5+ years of independent clinical monitoring experience preferred
Self-motivation, flexibility, ability to establish and manage multiple priorities, and multi-task effectively
Must exercise sound judgment and take initiative
Ability to work independently with minimal supervision while producing accurate high quality and timely work
Must be able to work effectively within a team environment (independently and collaboratively)
Excellent written and verbal communication skills including strong professional presentation skills
Thorough knowledge and understanding of ICH/GCPs and applicable regulatory requirements
Solid computer skills, including working knowledge of Microsoft Office applications (Word, Excel Outlook, etc.)
Understanding of current GCPs/ICH/FDA regulations and guidelines to assess compliance with applicable regulations and guidelines
Bachelor of Science degree in a scientific discipline from an accredited college or university is strongly preferred.

Benefits

health insurance
401k retirement plan
paid days off

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical monitoringdata integrityGCP protocolICH guidelinesSOPssite qualificationsite initiationquery resolutionTrial Master File (TMF)Electronic Trial Master File (eTMF)

Soft Skills

self-motivationflexibilitymulti-taskingsound judgmentinitiativeteamworkwritten communicationverbal communicationprofessional presentationability to manage priorities