Key Responsibilities:

• Study Coordination: Oversee the daily operations of clinical trials, including scheduling, site selection, patient recruitment, and participant enrollment.
• Regulatory Compliance: Ensure that all clinical trial activities comply with regulatory requirements, including FDA regulations, ICH-GCP guidelines, and company standard operating procedures (SOPs).
• Documentation and Reporting: Maintain accurate and up-to-date clinical trial documentation, including source documents, case report forms (CRFs), and regulatory submission documents. Prepare progress reports for management and stakeholders.
• Clinical Site Management: Collaborate with clinical sites to ensure proper site setup, monitor site activities, and ensure adherence to protocols. Act as the primary point of contact for site staff and investigators.
• Patient Safety: Monitor patient safety throughout the study, ensuring adverse events (AEs) are promptly reported and documented per regulatory requirements.
• Data Management: Support the collection, tracking, and management of clinical trial data. Ensure the accuracy, integrity, and completeness of trial data.
• Budget and Logistics: Assist with budget preparation, procurement of study materials, and logistical coordination, ensuring that the trials stay within scope and budget.
• Training and Support: Provide training and support to clinical trial sites and internal teams on study protocols, processes, and compliance requirements.
• Collaboration: Work closely with cross-functional teams, including regulatory affairs, quality assurance, and medical affairs, to ensure trial success and mitigate any issues or risks.
• Continuous Improvement: Participate in post-study activities, including data analysis, report preparation, and feedback for future clinical trials.
• NIH & IRB Submissions: Lead the preparation and submission of Institutional Review Board (IRB) applications and necessary documentation for clinical trials. Manage submissions and communicate with IRBs to ensure timely approvals. Experience with National Institutes of Health (NIH) grant submissions and reporting is a plus.

Qualifications:

• Bachelor’s degree in Biology, Chemistry, Neuroscience, Nursing, or a related field (required). Master’s degree or clinical research certification (e.g., CCRP) is a plus.
• 1+ years of experience in clinical research, preferably in the medical device industry, or a related field.
• Understanding of clinical research regulations, FDA requirements, ICH-GCP, and medical device regulations.
• Familiarity with clinical trial management software (CTMS) is a plus.
• Attention to detail and ability to handle multiple tasks simultaneously.
• Certifications: Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred.