About the position
As a Clinical Research Associate (CRA) at IQVIA, you 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 is dedicated to providing high-quality oversight of clinical research activities, ensuring that sites are conducting studies effectively and reporting data accurately. You will be responsible for performing site monitoring visits, which include selection, initiation, monitoring, and close-out visits, in accordance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Your role will involve collaborating closely with clinical sites to adapt and drive subject recruitment plans that align with project needs, enhancing predictability in recruitment efforts. You will administer protocol training to assigned sites and establish regular communication channels to manage ongoing project expectations and address any issues that arise. Evaluating the quality and integrity of study site practices is essential, and you will escalate any quality issues as necessary. In addition to monitoring, you will manage the progress of assigned studies by tracking regulatory submissions, recruitment and enrollment, case report form (CRF) completion, and data query resolution. You 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, ICH, and local regulatory requirements. Your documentation skills will be critical as you create and maintain records regarding site management, monitoring visit findings, and action plans. Collaboration with study team members will be key to executing projects effectively, and you may also be involved in site financial management according to the clinical trial agreement. This position requires a commitment to excellence and a proactive approach to problem-solving in the dynamic field of clinical research.
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.
- 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.
Requirements
- 2.5 years of clinical research coordination experience at site level
- Nursing or University Degree (US Bachelor Level or equivalent) in one of the life sciences
- Knowledge of electronic data capture preferred
- Equivalent combination of education, training and experience
Benefits
- Health insurance
- 401k
- Paid holidays
- Flexible scheduling
- Professional development opportunities
