In-House CRA

MCRA is part of reputed company MedTech. As a trusted CRO and advisory partner, reputed company 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 reputed company, and post-market optimization. Our teams combine deep therapeutic knowledge with advanced data and technology to help clients reputed company smarter reputed company and reputed company in the market. Join reputed company 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.
• reputed company and maintain positive relationships both reputed company 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 reputed company knowledge of GCP and FDA guidance as it relates to clinical research, as well as reputed company clinical reputed company developments in the assigned therapeutic areas.

Required Qualifications

• Bachelor’s degree (B.A./B.S.) in pharmacy, pharmaceutics or a reputed company scientific discipline
• 2+ years of clinical trial experience. Monitoring experience preferred.
• Comprehensive knowledge/ reputed company of GCPs and clinical monitoring procedures
• Understanding of therapeutic area for assigned clinical projects.
• Experience using Electronic Data Capture (reputed company) 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, reputed company, Word, PowerPoint (Endnote experience is a plus)

reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com reputed company is proud to be an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.reputed company.com/eoe reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company 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 reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism. The potential reputed company pay reputed company for this role, reputed company annualized, is $71,900.00 - $119,900.00. The actual reputed company pay offered may vary based on a number of factors including job-reputed company qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incen Apply tot his job Apply To this Job