Senior Clinical Research Associate, Full Service

$87,200 - $189,000/Yr

IQVIA - Parsippany-Troy Hills, NJ

Part-time - Mid Level

Parsippany-Troy Hills, NJ

Professional, Scientific, and Technical Services

About the position

IQVIA is seeking a Senior Clinical Research Associate (CRA) who will play a crucial role in the monitoring of clinical trials, particularly in the therapeutic areas of Central Nervous System (CNS) or Cardiovascular/Renal/Metabolic (CVRM). The ideal candidate will have at least 2 years of monitoring experience and will be responsible for performing site monitoring visits, which include selection, initiation, monitoring, and close-out visits. These activities must be conducted in accordance with the contracted scope of work and regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. In this position, the CRA will work closely with clinical sites to adapt, drive, and track subject recruitment plans that align with project needs, thereby enhancing predictability in recruitment efforts. The CRA will also administer protocol and related study training to assigned sites, establishing regular lines of communication to manage ongoing project expectations and address any issues that arise. The CRA will evaluate the quality and integrity of study site practices, ensuring adherence to the protocol and applicable regulations. This includes escalating quality issues as necessary. Additionally, the CRA will 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. The CRA may also support the start-up phase of studies. It is essential for the CRA to 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 in accordance with GCP and local regulatory requirements. The CRA will 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. Collaboration with study team members for project execution support is also a key aspect of this role.

Responsibilities

• Perform site monitoring visits including selection, initiation, monitoring, and close-out visits in accordance with GCP and 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 and monitoring visit findings, including regular visit reports and follow-up letters.
• Collaborate and liaise with study team members for project execution support.

Requirements

• Bachelor's Degree in a scientific discipline or health care preferred.
• At least 2 years of relevant experience including on-site monitoring.

Benefits

• Health and welfare benefits including medical, dental, and vision insurance.
• Incentive plans and bonuses based on performance.
• Opportunities for professional development and career growth.