Clinical Research Associate Jobs

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 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 CRA may also serve in the Lead CRA role. The CRA reports to a CTM/Sr. CTM and has no direct reports.

Primary Responsibilities:

• Escalate and assist in resolving any study related issues that arise during study conduct.
• Performs study monitoring visits, including site initiation, interim monitoring, and close-out visits. Trains site staff on study protocol and all relevant study procedures.
• Contribute to organizational and departmental process development, improvement, and implementation.
• Assist with site audits and site quality management activities, as needed.
• Assures adherence to GCP, study protocol, and all applicable requirements through routine monitoring visits.
• Performs investigational device inventory and accountability, in accordance with study monitoring plan. Facilitates return or destruction of any unused investigational device if required.
• 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.
• Ensure monitoring activities (remote and on-site) are completed in accordance with Agilent procedures and study monitoring plan.
• Support study start-up, conduct, and closeout activities. May assist in developing study-related plans and documents. May coordinate IRB/EC approvals.

Qualifications

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

The US pay range for this full-time position is $77,600.00 - $143,075.00/yr, plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position across the relevant US locations. 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. Additional details are available at: https://careers.agilent.com/locations/americas/united-states/

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 visit www.agilent.com/en/accessibility.

Travel Required

35% of the Time

Schedule

Schedule:Full time

Shift

Day

Duration

No End Date

Job Function

Medical/Clinical