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Clinical Research Associate II, Oncology, East Coast US Home-Based, IQVIA Biotech

Location: Durham, North Carolina; Columbus, Ohio
R1318845

At IQVIA Biotech, we offer a unique approach to serving biotech customers. A flexible model, therapeutically-aligned teams and dedicated resources in a transparent partnership. As a Senior Clinical Research Associate, you’ll have the opportunity to work directly with customers in a collaborative environment where you'll be part of a team bringing important treatments to patients.

In this highly specialized and dynamic role, you’ll utilize your extensive therapeutic knowledge to oversee uniquely-focused clinical studies. Working at the core of clinical research, you’ll be exposed to cutting-edge protocols and experience a dedicated partnership with your team like never before.

Join us and help reimagine the future of biotech.

  • Full Time
  • Level: Senior
  • Travel: Yes

Success profile

What makes a Senior Clinical Research Associate at IQVIA Biotech successful? Check out the top traits we’re looking for and see if you have the right mix.

  • COLLABORATIVE
  • INDEPENDENT
  • DETAIL-ORIENTED
  • ORGANIZED
  • EFFICIENT
  • PROBLEM-SOLVER

Explore this
career path

As you grow your CRA career at IQVIA Biotech, you’ll play an important role in helping our customers drive healthcare forward and impact the lives of patients around the world.

  1. CRA 1
  2. CRA 2
  3. Senior
    CRA 1
  4. Senior
    CRA 2
  5. Senior
    CRA 3

Quote

Lauren Heffron

“IQVIA empowers you to drive your own path within the organization. As no person’s route is the same and the clinical research landscape is forever changing, you are encouraged to continually seek career growth opportunities and to align your interests with your career goals.”

Lauren, Senior Clinical Research Associate 2

What you
can expect

  • Professional Development

    Resources that promote your career growth

  • Work-Life Balance

    Leaders that support flexible work schedules

  • Highly Specialized

    Roles that require specialty knowledge and training

  • Therapeutically Aligned

    Protocols aligned to your specific expertise

  • Variety

    Dynamic work environments that expose you to new experiences

  • Best-in-class Training

    Programs to help you build your therapeutic-knowledge

Clinical Research Associate II, Oncology, East Coast US Home-Based, IQVIA Biotech

Apply now
Location: Durham, North Carolina, United States R1318845

Job description

This position requires 1 year of on site monitoring experience.

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications
• Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Requires at least 1 year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

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