Sr CRA 1

Job Overview

The Sr Clinical Research Associate (CRA) is responsible for performing highquality monitoring activities and site management to ensure that clinical sites conduct studies in full compliance with the protocol ICHGCP guidelines regulatory requirements and sponsor expectations. This role plays a key part in safeguarding data integrity patient safety and overall study performance.

Essential Functions

• Conduct site monitoring visits (selection initiation routine monitoring and closeout) in alignment with the contracted scope of work and Good Clinical Practice.

• Partner with sites to develop adapt and track recruitment strategies to meet project timelines and enrollment targets.

• Deliver protocol and studyspecific training to site personnel; maintain consistent communication to manage expectations and resolve issues proactively.

• Assess the quality and integrity of site practices ensuring adherence to protocol and regulatory requirements; escalate quality concerns when necessary.

• Track study progress including regulatory submissions approvals enrollment metrics CRF completion and data query resolution; may support startup activities.

• Ensure essential documents are complete and properly filed in the Trial Master File (TMF) and that the Investigator Site File (ISF) meets GCP and local regulatory standards.

• Document all site management and monitoring activities through visit reports followup letters and required study documentation.

• Collaborate with crossfunctional study team members to support project execution.

• When applicable support development of sitelevel recruitment plans and manage site financial activities according to the clinical trial agreement.

Qualifications

• Bachelors degree in a scientific or healthcarerelated field preferred; equivalent education training and experience may be considered.

• Minimum of 4 years of onsite monitoring experience required.

• Strong interest and/or handson experience in oncology clinical trials; prior involvement in oncology studies strongly preferred.

• Solid understanding of clinical research regulations including GCP and ICH guidelines.

• Strong therapeutic and protocol knowledge with the ability to quickly learn new indications.

• Proficiency with Microsoft Word Excel PowerPoint and mobile technology (laptop iPhone iPad where applicable).

• Excellent written and verbal communication skills including strong command of the English language.

• Strong organizational problemsolving and timemanagement abilities.

• Ability to build and maintain effective working relationships with colleagues site staff managers and clients.

• Demonstrated ability to work independently manage multiple priorities and maintain highquality standards.

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.