MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner, IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together, we support innovation from concept to commercialization, offering expertise in regulatory strategy, clinical trial design and execution, market access, and post-market optimization. Our teams combine deep therapeutic knowledge with advanced data and technology to help clients make smarter decisions and thrive in the market. Join our team to help shape the future of MedTech.
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 firm’s 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
Bachelor’s 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 https://jobs.iqvia.com
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. https://jobs.iqvia.com/eoe
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.
The potential base pay range for this role, when annualized, is $74,500.00 - $124,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.