Senior Clinical Research Associate

Job Description

• 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 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

In addition to the primary, the Senior CRA will also be expected to take on the following responsibilities:

• Assist and/or develop study-related plans and documents including clinical protocol, clinical brochures/lFUs, development of CRFs, informed consent forms, monitoring plan, etc.

• Assist in training new CRA staff by supporting remote monitoring, co-monitoring and/or mentoring

• Assist the project management team in identifying risks in study execution at study sites, implement mitigations, monitoring outcomes, and communicate observations

• Demonstrate an ability to influence others, especially study site staff, to achieve positive results and collaboration through diplomacy and respect for others, appropriate prioritization and facilitation of the decision-making process

• Demonstrate a high degree of competence in clinical research with prior exposure to all aspects of clinical study and functions at a proficient level of independence with a significant degree of autonomy in conducting clinical research

• Provide guidance and mentorship to junior team members

• May serve as Lead CRA or Lead monitor for assigned studies

• Works closely with other assigned CRAs to track monitoring deliverables and metrics in accordance with the study monitoring plan

• May actively participate as a member of the cross-functional project team

Qualifications

• Bachelor's degree in biological sciences or medical specialty or higher, or equivalent credentials

• For Senior CRA: 5+ years direct clinical research experience at a sponsor, device manufacturer, IVD, companion diagnostics as a CRA/study monitor, or equivalent experience

• Experience with Electronic Data Capture (EDC) systems and eTMF systems

• 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

• 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

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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 June 27, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $100,720.00 - $188,850.00/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: https://careers.agilent.com/locations

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:

50% of the Time

Shift:

Day

Duration:

No End Date

Job Function:

Medical/Clinical