Clinical Research Associate

Job Description

Summary:
The Clinical Research Associate (CRA) will support successful and timely start-up and completion of clinical trials and be a key member of the Organization of the Chief Medical Officer (OCMO) Global Clinical Operations team. This will include oversight and management of assigned study(ies) associated investigator sites and monitoring activities. The CRA will monitor clinical trials in accordance with Good Clinical Practice (GCP), Agilent procedures, and all applicable regulations. 

The CRA works closely with the Clinical Trial Manager (CTM) and/or lead CRA to ensure all monitoring activities are conducted according to study requirements and Monitoring Plan. The CRA may report to a CTM, Sr CTM, CPM or people manager and has no direct reports.

Primary Responsibilities (all levels):

•  Performs all study monitoring visits and completes supporting visit reports, including applicable visits such as site/investigator qualification, site initiation, interim monitoring, remote monitoring, and close-out visits
•  Trains investigator(s) and site staff on study protocol and all relevant study procedures
•  Supports study start-up, conduct, and closeout activities. May assist in developing study­ related plans and documents including clinical protocol, development of CRFs, reviewing informed consent forms, monitoring plan, etc. May coordinate IRB/EC approvals
•  Functions independently in the field and interacts professionally with all levels of medical and scientific professionals
•  Identify early on any unsatisfactory results, operations or specific problems and take immediate action to appropriate groups including escalating and assisting in resolving any study related issues that arise during study conduct
•  Assures adherence to GCP, study protocol, procedures, all applicable requirements, and regulations throughout the study monitoring visits. Responsible for implementing and maintaining the effectiveness of the quality system
•  Collect and review site regulatory and essential documents for accuracy and completion. Maintain the study Trial Master File (TMF)/or eTMF and ensure the Investigator Site Files (ISFs) are current and maintained
•  Perform Source Data Verification (SDV) and data cleaning in accordance with study monitoring plan. Reviewing all study logs and documentation ensuring audit trail and chain of custody is maintained
•  Performs Investigation Use Only (IUO) inventory and accountability, in accordance with study monitoring plan. Facilitates return or destruction of any unused IUO material as required
•  Serve as the primary point of contact for assigned sites and works with sites to resolve data queries and monitoring findings. Maintains accurate and timely communications with sites and ensures records are filed in TMF/ISF
•  Ensures TMF/ISF is audit ready. Assists with site audit(s) and site quality management 
activities, as needed. Tracks site progress against contractual agreements
•  Contribute to organizational and departmental process development, improvement, and implementation
 

Qualifications

•  Bachelor's degree or higher, or equivalent credentials
•  Knowledge of International Council for Harmonisation (ICH)/GCP guidelines, 21 CFR (Code of Federal Regulations) part 812 (lnvestigational Device Exemption) (IDE)), and monitoring procedures/best practices (ICH E6(R2))
•  Demonstrating strong written and verbal communication skills and presentation skills
•  Track record demonstrating strong organizational and problem-solving skills
•  Track record demonstrating a strong work ethic and ability to deliver tasks on time
•  Proficient with Microsoft Office Suite including automation tools
•  For CRA: 1+ years direct clinical research experience at a sponsor, CRO, device manufacturer
•  Experience with Electronic Data Capture (EDC) systems and eTMF systems

Preferred Qualifications:

•  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), lmmunohistochemistry (IHC), and/or pathology

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Additional Details

This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least October 30, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $62,560.00 - $117,300.00/yr plus eligibility for bonus, stock and benefits. Our pay rang