Description
Join IQVIA Biotech, where innovation meets impact. You'll be at the forefront of groundbreaking therapies and novel diseases, often before they reach the broader scientific community.
Responsibilities
- Perform site monitoring visits in accordance with contracted scope of work and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt, drive and track subject recruitment plans 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.
- 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.
- Ensure copies/originals 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/ICH and local regulatory requirements.
- Create and maintain documentation regarding site management, monitoring visit findings and action plans.
- Collaborate and liaise with study team members for project execution support as needed.
Qualifications
- Minimum of 3-4 years of on-site monitoring experience.
- Experience monitoring Oncology studies is required.
- Bachelor's Degree in a scientific discipline or healthcare preferred.
- Basic knowledge of and skill in applying applicable clinical research regulatory requirements (GCP and ICH guidelines).
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in Microsoft Word, Excel and PowerPoint.
- 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.