About the position
IQVIA Biotech is seeking an experienced on-site Clinical Research Associate (CRA) with a focus on oncology to join our team in the Central region. The CRA will play a crucial role in monitoring and managing clinical trial sites to ensure compliance with study protocols, applicable regulations, and sponsor requirements. This position involves performing site monitoring visits, including selection, initiation, monitoring, and close-out visits, in accordance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. The CRA will work closely with sites to adapt and track subject recruitment plans, ensuring alignment with project needs to enhance predictability in recruitment outcomes. In addition to site monitoring, the CRA will administer protocol and study training to assigned sites, establishing regular communication to manage ongoing project expectations and address any issues that arise. Evaluating the quality and integrity of study site practices is essential, and the CRA will escalate any quality issues as necessary. The role also includes managing the progress of assigned studies by tracking regulatory submissions, recruitment and enrollment, case report form (CRF) completion, and data query resolution. The CRA will ensure that all necessary site documents are available for filing in the Trial Master File (TMF) and that the Investigator's Site File (ISF) is maintained according to GCP and local regulatory requirements. Documentation is a key aspect of this role, as the CRA will create and maintain records regarding site management, monitoring visit findings, and action plans. Collaboration with study team members is essential for effective project execution. Depending on the project, the CRA may also be involved in developing site-specific subject recruitment plans and managing site financials according to the clinical trial agreement. This position requires a Bachelor's Degree in a scientific discipline or healthcare, along with at least one year of on-site monitoring experience, or an equivalent combination of education and experience. Strong knowledge of clinical research regulatory requirements, excellent communication skills, and proficiency in Microsoft Office applications are also necessary for success in this role.
Responsibilities
- Perform site monitoring visits including selection, initiation, monitoring, and close-out visits in accordance with regulatory requirements and GCP/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 communication to manage project expectations.
- Evaluate the quality and integrity of study site practices and escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions, recruitment, CRF completion, and data query resolution.
- Ensure site documents are available for filing in the TMF and verify that the ISF is maintained according to GCP and local regulations.
- Create and maintain documentation regarding site management, monitoring visit findings, and action plans.
- Collaborate and liaise with study team members for project execution support.
- Support development of project subject recruitment plans on a per site basis, if applicable.
- Manage site financials according to the clinical trial agreement, if applicable.
Requirements
- Bachelor's Degree in a scientific discipline or healthcare preferred.
- At least 1 year of on-site monitoring experience required.
- Equivalent combination of education, training, and experience may be accepted in lieu of degree.
- Good knowledge of clinical research regulatory requirements (GCP and ICH guidelines).
- Good therapeutic and protocol knowledge as provided in company training.
- Proficiency in Microsoft Word, Excel, and PowerPoint, and use of a laptop computer and iPhone/iPad.
- Strong written and verbal communication skills, with a good command of the English language.
- Excellent organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Benefits
- Health insurance
- 401k retirement plan
- Paid time off
- Professional development opportunities
- Flexible scheduling options
