Cra (Clinical Research Associate)

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

The Clinical Research Associate (CRA)/ Senior CRA will support ongoing and new clinical trials and be a key member of the clinical affairs team. This will include management of assigned investigator sites and all monitoring activities for assigned studies. The CRA will monitor clinical trials in accordance with Good Clinical Practice, Agilent procedures, and 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/Monitoring Plan. The Senior CRA may also serve in the Lead CRA role. The CRA reports to a CTM/Sr. CTM and has no direct reports.

Primary Responsibilities:

• Performs investigational device inventory and accountability, in accordance with study monitoring plan. Facilitates return or destruction of any unused investigational device if required.
• Support study start-up, conduct, and closeout activities. May assist in developing study-related plans and documents. May coordinate IRB/EC approvals.
• Collect and/or review site regulatory documents for accuracy and completion. Perform source data verification in accordance with study monitoring plan. Maintain the study Trial Master File (TMF)/or eTMF and ensure the Investigator Site Files (ISFs) are current and maintained.
• Provide guidance and mentorship to junior team members.
• Performs study monitoring visits, including site initiation, interim monitoring, and close-out visits. Trains site staff on study protocol and all relevant study procedures.
• Ensure monitoring activities (remote and on-site) are completed in accordance with Agilent procedures and study monitoring plan.
• Serve as the primary point of contact for assigned sites and works with sites to resolve data queries and monitoring findings.
• Assist with site audits and site quality management activities, as needed.
• As lead CRA, serve as the lead monitor for assigned studies. Works closely with other assigned CRAs to track monitoring deliverables and metrics in accordance with the study monitoring plan.
• Contribute to organizational and departmental process development, improvement, and implementation.
• Escalate and assist in resolving any study related issues that arise during study conduct.
• Assures adherence to GCP, study protocol, and all applicable requirements through routine monitoring visits.

Qualifications

Please update the minimum qualifications below to reflect the requirements for your specific role.

• Prior experience working with high-complexity CLIA or CAP accredited laboratories conducting clinical trial testing is highly preferred.
• Working experience with electronic data capture (EDC) systems and eTMF systems is a plus.
• Knowledge of ICH GCP guidelines and monitoring procedures/best practices.
• Diagnostic/IVD experience highly preferred, oncology or other medical device experience is also accepted.
• Proficient with office automation tools, such as Microsoft Office.
• Bachelors degree or higher, or equivalent credentials
• Previous experience with NGS, IHC, or pathology highly preferred.
• Strong written and verbal communication skills and presentation skills.
• Strong work ethic and ability to deliver tasks on time.
• Certification in clinical research is highly preferred (CCRA, CCRP, etc.).
• Strong organizational and problem-solving skills.
• 3+ years direct clinical research experience at a sponsor or CRO as a CRA/study monitor, or equivalent experience.

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 [email protected] or contact +1-262-754-5030.

For more information about equal employment opportunity protections, please see all of our notices for EEO below.

Travel Required

35% of the Time

Schedule

Schedule:Full time

Shift

Day

Duration

No End Date

Job Function

Medical/Clinical