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Clinical Research Associate - IQVIA Biotech

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IQVIA

1mo ago

  • Job
    Full-time
    Junior Level
  • Research & Development
    Healthcare
  • Reading

AI generated summary

  • You must have 1+ year of oncology monitoring experience, a science/health degree (or equivalent), GCP/ICH knowledge, strong computer skills, and excellent communication and problem-solving abilities.
  • You will conduct site monitoring visits, ensure compliance with GCP/ICH, manage site communication, track study progress, maintain documentation, and support recruitment and financial management as needed.

Requirements

  • Minimum of 1 year of experience of on-site monitoring experience
  • Experience monitoring Oncology studies is a must
  • Bachelor's Degree in scientific discipline or health care preferred
  • Equivalent combination of education, training and experience may be accepted in lieu of degree.
  • Basic 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, 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.

Responsibilities

  • 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) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH 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.

FAQs

What is the primary responsibility of a Clinical Research Associate at IQVIA Biotech?

The primary responsibility is to perform site monitoring visits, including selection, initiation, monitoring, and close-out visits, in line with regulatory requirements and Good Clinical Practice (GCP) guidelines.

Is experience in Oncology studies required for this position?

Yes, experience monitoring Oncology studies is a must for this role.

What is the minimum required experience for applicants?

A minimum of 1 year of on-site monitoring experience is required for this position.

What type of educational background is preferred for this role?

A Bachelor's Degree in a scientific discipline or healthcare is preferred, but an equivalent combination of education, training, and experience may be accepted in lieu of a degree.

Are there specific regulatory knowledge requirements for this job?

Yes, candidates should have basic knowledge of and skills in applying applicable clinical research regulatory requirements, such as GCP and ICH guidelines.

What skills are essential for this position?

Essential skills include proficiency in Microsoft Word, Excel, and PowerPoint, strong written and verbal communication skills, organizational and problem-solving skills, and effective time and financial management abilities.

Will I be expected to manage site financials?

Yes, if applicable, you may be accountable for site financial management according to the executed clinical trial agreement.

Are there opportunities for collaboration with study team members?

Yes, the role involves collaboration and liaison with study team members for project execution support as appropriate.

Does this position offer visa sponsorship for applicants from the UK?

No, this role is not eligible for UK visa sponsorship.

How can I learn more about IQVIA's contributions to clinical research?

You can learn more about IQVIA and their contributions to clinical research by visiting their website at https://jobs.iqvia.com.

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IQVIA

Accelerate innovation for a healthier world.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 86,000 employees, IQVIA conducts operations in more than 100 countries. IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures.

Benefits

  • Medical, dental and vision coverage

  • Employee Assistance Programs

  • Mental health support

  • Flexible work environment

  • Time off for leisure, personal time and corporate holidays

  • Parental leave for birth or adoption

  • Paid leave for other life matters (i.e., illness, bereavement, jury duty, military service, etc.)

  • Retirement and savings plans

  • Commuter benefits

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