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 Chief Medical Officer (OCMO) Global Clinical Affairs team. This will include oversight and management of assigned studies associated with 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 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
Support study start-up, conduct, and closeout activities. May assist in developing study-related plans and documents including clinical protocol, clinical brochures/IFUs, 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) or Research Use Only (RUO) inventory and accountability, in accordance with study monitoring plan. Facilitates return or destruction of any unused IUO/RUO 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
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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 (Investigational 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 I: 1+ years direct clinical research experience at a sponsor, CRO, device manufacturer, IVD, companion diagnostics or investigator site
Experience with Electronic Data Capture (EDC) systems and eTMF systems
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Additional Details
This job has a full time weekly schedule. Applications for this job will be accepted until at least October 21, 2024 or until the job is no longer posted. The full-time equivalent pay range for this position is $81,480.00 - $127,313.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. 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 and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit Travel Required35% of the Time ShiftDay DurationNo End Date Job FunctionMedical/Clinical