Agilent Technologies is looking for a Clinical Research Associate to join the Organization of the Chief Medical Officer (OCMO) Global Clinical Operations team. You will be instrumental in ensuring the successful and timely start-up and completion of clinical trials, overseeing assigned studies and sites in compliance with GCP, Agilent procedures, and all applicable regulations.
What You'll Do
- Perform all study monitoring visits, including site qualification, initiation, interim, remote, and close-out visits, and complete supporting visit reports.
- Train investigator(s) and site staff on the study protocol and all relevant study procedures.
- Support study start-up, conduct, and closeout activities; assist in developing study-related plans and documents and coordinate IRB/EC approvals.
- Identify and escalate study-related issues early and take immediate action to assist in resolution.
- Assure adherence to GCP, study protocols, procedures, and all applicable requirements throughout monitoring visits; implement and maintain quality system effectiveness.
- Collect and review site regulatory documents; maintain the study Trial Master File (TMF)/eTMF and ensure Investigator Site Files (ISFs) are current.
- Perform Source Data Verification (SDV) and data cleaning; review all study logs and documentation to maintain audit trail and chain of custody.
- Perform Investigation Use Only (IUO) inventory and accountability; facilitate return or destruction of any unused IUO material.
- Serve as the primary point of contact for assigned sites to resolve data queries and monitoring findings.
- Ensure TMF/ISF is audit ready; assist with site audits and quality management activities; track site progress against contractual agreements.
- Contribute to organizational and departmental process development, improvement, and implementation.
What We're Looking For
- Bachelor's degree or higher, or equivalent credentials.
- Knowledge of ICH/GCP guidelines, 21 CFR part 812 (IDE), and monitoring procedures/best practices (ICH E6(R2)).
- Strong written and verbal communication and presentation skills.
- Demonstrated strong organizational and problem-solving skills.
- Demonstrated strong work ethic and ability to deliver tasks on time.
- Proficient with Microsoft Office Suite including automation tools.
- 1+ years direct clinical research experience at a sponsor, CRO, or device manufacturer.
- Experience with Electronic Data Capture (EDC) systems and eTMF systems.
Nice to Have
- Bachelor's degree in biological sciences or medical specialty or higher, or equivalent credentials.
- Molecular diagnostic, medical device, in vitro diagnostic (IVD), companion diagnostics, oncology and/or pathology experience.
- Previous experience with Next Generation Sequencing (NGS), Immunohistochemistry (IHC), and/or pathology.
Technical Stack
- Microsoft Office Suite including automation tools
- Electronic Data Capture (EDC) systems
- eTMF systems
Team & Environment
You will be a key member of the Organization of the Chief Medical Officer (OCMO) Global Clinical Operations team, working closely with the Clinical Trial Manager (CTM) and/or lead CRA. You may report to a CTM, Sr CTM, CPM, or people manager.
Benefits & Compensation
- Eligibility for bonus, stock, and benefits.
- Compensation: $62,560.00 - $117,300.00/yr
Work Mode
This position follows a hybrid work mode.
Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation.
