Clinical Trial Specialist

Act as primary local company contact for assigned trial sites. Lead executional aspects of sponsored clinical trials with appropriate oversight. Participate in site feasibility and pre-trial site assessment visits. Attend investigator meetings as needed. Complete site initiation, start-up, monitoring, site management, and site/study close-out activities according to SOPs, work instructions, and policies. Develop clinical trial documents such as monitoring plans and informed consent documents. Implement analytical risk-based monitoring at the site level and ensure timely issue resolution. Collaborate with and may oversee Clinical Research Associates. Ensure site staff training and accurate, complete training records. Collaborate with the Clinical Research Manager during site activation. Ensure timely site data entry and query resolution. Ensure accuracy, validity, and completeness of trial-site data. Ensure Adverse Events, Serious Adverse Events, and Product Quality Complaints are reported and documented within required timelines. Oversee ordering, tracking, and accountability of investigational devices and trial materials. Maintain complete and timely trial data and essential documents in relevant systems. Document trial activities, write visit reports and follow-up letters, and communicate status and issues. Review study files and ensure archiving and retention requirements. Attend team meetings and training and develop therapeutic knowledge. Work with the Clinical Trial Leader on CAPA completion for QA audits and site quality issues. Prepare sites for close-out and conduct final close-out visits. Track site-level costs and ensure payments are made when applicable. Maintain relationships with internal and external partners, investigators, trial coordinators, and site staff. Contribute to process improvement and training. Lead or participate in special initiatives and may serve as a Champion or Subject Matter Expert. 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, clinical trends, and global clinical trial regulations. Previous experience in medical device monitoring is strongly preferred. Understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products. Relevant industry certifications preferred (i.e., CCRA, RAC, CDE). Ability and willingness for up to 40% travel, mostly domestic, is required. Clinical/medical background preferred. Experience and knowledge working with Microsoft Office: Excel, Word, PowerPoint and Outlook. Strong computer skills in appropriate software and related company clinical systems. Presentation and influencing skills. Strong organizational skills, including managing multiple sub-projects and tasks and meeting deadlines. Core Competencies Demonstrates expertise in managing clinical trials, including site initiation, monitoring, and close-out activities, while ensuring compliance with regulations and standards. Proficient in developing clinical trial documents and maintaining accurate trial data and essential documents. Highest-signal resume keywords Clinical Trial Management Site Monitoring Regulatory Compliance Clinical Research Experience Data Management Hard Skills Clinical Trial Execution Site Feasibility Assessment Monitoring Plan Development Risk-Based Monitoring Adverse Event Reporting Data Entry and Query Resolution Investigational Device Accountability CAPA Completion Process Improvement Therapeutic Knowledge Soft Skills Presentation Skills Organizational Skills Influencing Skills Certifications & Qualifications CCRA RAC CDE Industry Keywords Clinical Research Medical Device Monitoring Global Clinical Trial Regulations Life Science Biological Science Tools & Technologies Microsoft Office Clinical Systems #J-18808-Ljbffr