Reporting to the Director - Clinical Monitoring, primarily responsible for the management of clinical sites and monitoring of clinical data at assigned sites.
The Clinical Research Associate (CRA) will 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.
Other work-related duties, special projects, and/or other functions, as required.

Requirements

Minimum of 2 years of experience in a Clinical Trial Assistant or other supporting project role with high attention to detail (3+ years of clinical monitoring experience preferred).
Prior experience with oncological trials strongly preferred.
Self-motivation, flexibility, ability to establish and manage multiple priorities, and multi-task effectively to meet stated internal and external commitments.
Must exercise sound judgment and take initiative, be able 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 (internal and external audiences).
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.

Benefits

health insurance
401k retirement plan
paid days off
annual performance bonus

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical monitoringdata integrityquery resolutionsite qualificationsite initiationinterim monitoringcloseout monitoringreport writingregulatory complianceclinical trial management

Soft Skills

attention to detailself-motivationflexibilitymulti-taskingsound judgmentinitiativeindependenceteam collaborationcommunication skillsprofessional presentation