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.

• 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.

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.

• Clinical Trial Management
• Site Monitoring
• Regulatory Compliance
• Clinical Research Experience
• Data Management

• 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

• Presentation Skills
• Organizational Skills
• Influencing Skills

• CCRA
• RAC
• CDE

• Clinical Research
• Medical Device Monitoring
• Global Clinical Trial Regulations
• Life Science
• Biological Science

• Microsoft Office
• Clinical Systems