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 Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents. Oversee ordering, tracking, and accountability of investigational devices and trial materials. Maintain complete, accurate and timely data and essential documents in relevant systems used for trial management. Fully document trial related activities, in particular monitoring. Writes visit reports and follow-up letters in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate partners. Review study files for completeness and ensures archiving retention requirements are met, always including storage in a secure area. Attend regularly scheduled team meetings and training. Follow relevant training requirements. Develops therapeutic knowledge sufficient to support role and responsibilities. Work closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, Prepare trial sites for close out, conduct final close out visit. Track costs at site level and ensure payments are made, if applicable. Establish and maintain good working relationships with internal and external partners, investigators, trial coordinators and other site staff. Act as a point of contact in site management practices. Contribute to process improvement and training. Lead and/or participate in special initiatives as assigned. May assume additional responsibilities or special initiatives such as “Champion” or Subject Matter Expert”. Qualifications and Requirements: A Bachelor Degree is required , preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science. 3+ years of experience working in clinical trials is required ; MS with at least 2 years, PhD with at least 1 year of related experience . Previous clinical research experience is required . Good understanding of clinical research science and processes along with an understanding of clinical trends and global clinical trial regulations is required . Previous experience in medical device monitoring is strongly preferred; requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products. Relevant industry certifications preferred (i.e., CC