Clinical Trial Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Operations Job Sub Function: Clinical Trial Support Job Category: Professional All Job Posting Locations: Cincinnati, Ohio, United States of America, Santa Clara, California, United States of America Job Description: Johnson & Johnson MedTech Clinical advances innovation through clinical studies that evaluate how technologies perform in real-world healthcare settings with clinicians, workflows, and patients. The evidence generated through these studies helps improve products, build confidence in their safety and effectiveness, and supports better experiences and outcomes for healthcare teams and the patients they serve. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Johnson & Johnson MedTech is currently recruiting for a Clinical Trial Specialist – MedTech . The position can be located in Cincinnati, OH or Santa Clara, CA. This position requires the candidate to work a full onsite schedule with 5 days per week in the office. Purpose: The Clinical Trial Specialist is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulations and guidelines from study start-up through clinical study report. Responsibilities may include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring, close-out activities, and additional study-specific activities at the trial site. The Clinical Trial Specialist may lead portions of the clinical operations execution in partnership with the Clinical Trial Leader. Role and Responsibility Act as primary local company contact for assigned sites for specific trials. Leads executional aspects of sponsored clinical trials with appropriate oversight. Participate in site feasibility and/or pre-trial site assessment visits. Attend/participate in investigator meetings as needed. Complete activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. May develop clinical trial documents, such as monitoring plans, informed consent. Implement of analytical risk-based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. Works with, collaborates with and may oversee Clinical Research Associates (CRAs). Ensure site staff are trained, and the corresponding training records are complete and accurate at any time point during all trial phases. Work in close collaboration with Clinical Research Manager for the activities during site activation phase to speed up the process and activate the site in shortest possible timeframe. Ensure site staff complete data entry and resolve queries within expected timelines. Ensure accuracy, validity and completeness of data collected at trial sites Ensure that all