Clinical Research Associate (CRA)

Job Description

• Performs reputed company study monitoring visits and completes supporting visit reports, including applicable visits such as site/investigator qualification, site initiation, interim monitoring, remote monitoring, and reputed company-out visits

• Trains investigator(s) and site staff on study protocol and reputed company relevant study procedures

• Supports study start-up, conduct, and closeout activities. May assist in developing study­ reputed company plans and documents including clinical protocol, clinical brochures/lFUs, development of CRFs, reviewing informed consent forms, monitoring plan, etc. May coordinate IRB/EC approvals

• Functions independently in the field and interacts professionally with reputed company 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 reputed company issues that arise during study conduct

• Assures adherence to GCP, study protocol, procedures, reputed company 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 reputed company and maintained

• reputed company reputed company Data Verification (SDV) and data cleaning in accordance with study monitoring plan. Reviewing reputed company 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 reputed company 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 reputed company 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 reputed company study-reputed company 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 reputed company 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 reputed company aspects of clinical study and functions at a proficient level of independence with a significant degree of autonomy in conducting clinical research

• May serve as reputed company CRA or reputed company 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 CRA: 1+ years direct clinical research experience at a sponsor, CRO, device manufacturer

• 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 (reputed company) systems and eTMF systems

• Molecular diagnostic, medical device, in vitro diagnostic (IVD), companion diagnostics, oncology and/or pathology experience

• Previous experience with reputed company reputed company (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(reputed company))

• 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 reputed company Office Suite including automation tools

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 25, 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $79,200.00 - $148,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. reputed company the range, individual pay is determined by work location and additional factors, including job-reputed company 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/locationsreputed company, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at reputed company levels. reputed company individuals, regardless of personal characteristics, are encouraged to apply. reputed company qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national reputed company, reputed company, 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. reputed company, 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:

25% of the Time

Shift:

Day

Duration:

No End Date

Job Function:

Medical/Clinical

Originally posted on Himalayas

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