In-House CRA

Position Overview

The In-House Clinical Research Associate/ MedTech Site Manager 1 will be a critical team member reporting directly to the Director of Clinical Affairs to support clinical trial operations for the firms clientele. Responsible for management of investigator site and Clinical Research Associate (CRA) activities for assigned studies. The In-House CRA will execute Clinical Affairs functions in accordance with Good Clinical Practice (GCP) guidelines Standard Operating Procedures (SOPs) and any other applicable regulatory requirements.

Position Responsibilities

• Review and approve research and study regulatory documents required for the implementation monitoring and evaluation of clinical trials.
• Review clinical protocols to ensure collection of data needed for regulatory submissions
• Contribute to protocol-specific manuals plans and documents as needed.
• Ensure that monitoring activities (remote and on-site) are completed in accordance with company/client SOPs and Clinical Monitoring Plan.
• Assist project manager with clinical study planning and management as required.
• Develop and maintain positive relationships both internal and external to project including clients team members and site personnel (PIs Study coordinators etc.).
• Assist in the identification and recruitment of potential investigators and study sites as needed.
• Ensure Trial Master File is accurate and complete throughout the lifecycle of the project.
• Assist with site training for assigned clinical trials.
• Assist with site audits and site quality management activities as needed.
• Maintain current knowledge of GCP and FDA guidance as it relates to clinical research as well as current clinical related developments in the assigned therapeutic areas.

Required Qualifications

• Bachelors degree (B.A./B.S.) in pharmacy pharmaceutics or a related scientific discipline
• 2 years of clinical trial experience. Monitoring experience preferred.
• Comprehensive knowledge/ fluency of GCPs and clinical monitoring procedures
• Understanding of therapeutic area for assigned clinical projects.
• Experience using Electronic Data Capture (EDC) and clinical trial management systems.
• Possesses strong written and verbal communication and presentation skills.
• Strong research analytical critical-thinking and problem solving skills
• PC/Technical skills - MS Office Excel Word PowerPoint (Endnote experience is a plus)

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 proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. 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.