Clinical Research Associate null

About IQVIA

IQVIA 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. 

Your responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with the 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 plans 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 the start-up phase.
• Ensure copies/originals (as required) of 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, and 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 the development of project subject recruitment plan on a per-site basis.
• If applicable, may be accountable for site financial management according to the executed clinical trial agreement and retrieve invoices according to local requirements.

Training & development

Advancing healthcare requires people who are willing to explore new ideas, build on successes, and learn from mistakes. Some of the learning & development that IQVIA provides:

• Training systems
• AI talent marketplace tool
• Leadership training programs
• Employee recognition programs
• Mentorship programs

Benefits

Benefits of working at IQVIA include:

• Health & well-being
• Medical, dental, and vision coverage
• Critical illness coverage
• Prescription coverage
• Disability, accidental death, pet and life insurance
• Employee Assistance Programs
• Mental health support
• Well-being programs and events
• Flexibility & time off
• Flexible work environment
• Learning & development
• Community engagement
• Retirement and savings plans

Career progression

They are always learning and seeking opportunities for personal, professional, and organizational growth. At IQVIA, you are encouraged to grow and stretch into new opportunities. This could mean climbing the traditional career ladder, or exploring various therapeutic areas and/or other clinical career paths across monitoring, project management, site activation, operations, and more!   

Work-life balance

IQVIA understands life’s complexities so no matter the role, they strive to find the balance of work flexibility so you can succeed both professionally and personally.

Read more here...

Company culture

IQVIA is deeply rooted in the healthcare industry, and its culture reflects a commitment to improving human health. Employees often feel a sense of purpose in contributing to advancements in healthcare through their work.

About you

• Bachelor's Degree in a scientific discipline or health care preferred.
• Prior on-site monitoring experience; or equivalent combination of education, training, and experience.
• 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 the 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.

How to apply

Please click on the "Apply on employer site" button to apply.

Source/s:

• youtube.com
• iqvia.com