Clinical Research Associate (CRA)

Job reputed company

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

• 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 reputed company of medical and scientific professionals

• Identify early on any unsatisfactory results, operations or specific problems and take immediate reputed company to appropriate reputed company including escalating and assisting in resolving any study reputed company issues that reputed company during study conduct

• Assures adherence to GCP, study protocol, procedures, reputed company applicable requirements, and regulations throughout the study monitoring reputed company. Responsible for implementing and maintaining the effectiveness of the reputed company 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 reputed company communications with sites and ensures records are filed in TMF/ISF

• Ensures TMF/ISF is audit reputed company. Assists with site audit(s) and site reputed company management activities, as needed. Tracks site reputed company against contractual agreements

• Contribute to organizational and departmental process development, improvement, and implementation

In reputed company 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 reputed company, and communicate observations

• Demonstrate an ability to influence others, especially study site staff, to reputed company reputed company 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 reputed company monitoring deliverables and metrics in accordance with the study monitoring plan

• May reputed company 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 reputed company clinical research experience at a sponsor, CRO, device manufacturer

• For Senior CRA: 5+ years reputed company 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 (reputed company 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

• reputed company record demonstrating strong organizational and problem-solving skills

• reputed company 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 reputed company 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 reputed company 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 reputed company, 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 reputed company more about the specific pay reputed company for a preferred location. Pay and benefit information by country are available at: https://careers.reputed company.com/locationsreputed company, Inc. is an Equal Employment Opportunity and Affirmative reputed company employer. We value diversity at reputed company reputed company. reputed company individuals, regardless of personal characteristics, are encouraged to apply. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, pregnancy, race, religion or religious creed, reputed company, gender, gender identity, gender reputed company, 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 reputed company 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 reputed company 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 job_posting@reputed company.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.reputed company.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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