Clinical Trial Specialist

About Regenerative Stem Cell Therapies at SMSbiotech:
We are pioneers in regenerative stem cell therapies, committed to democratizing the application of adult stem cell technologies for human health. Our collaborative and dynamic environment fosters innovation and encourages every team member to contribute to our success.

Position Overview:
SMSbiotech seeks a highly motivated Clinical Trial Specialist to join our expanding clinical operations team. The ideal candidate will ensure the smooth execution and management of our clinical trials, working collaboratively across internal departments and external partners. This role requires a proactive individual with a strong understanding of clinical trial processes, regulatory guidelines, and a passion for advancing medical research.

Main Responsibilities:
Trial Coordination and Management:

• Oversee day-to-day trial operations, ensuring adherence to study protocols, timelines, and regulatory requirements.
• Maintain accurate and up-to-date trial documentation, including study protocols, informed consent forms, and regulatory submissions.
• Track and manage study supplies, including investigational products, ensuring proper storage and distribution.
• Monitor trial progress, identify potential issues, and proactively implement solutions to maintain study timelines.

Cross-Functional Collaboration:

• Serve as primary point of contact for internal departments (e.g., medical affairs, data management, regulatory affairs) and external partners (e.g., CROs, investigational sites).
• Facilitate effective communication and collaboration among all stakeholders to ensure seamless trial execution.
• Coordinate and participate in investigator meetings, site initiation visits, and monitoring visits.

Regulatory Compliance:

• Ensure compliance with all applicable regulatory guidelines (e.g., GCP, ICH) and company SOPs.
• Assist in the preparation and submission of regulatory documents to relevant authorities.
• Maintain a thorough understanding of current regulatory requirements and industry best practices.

Data Management and Reporting:

• Monitor data quality and integrity, ensuring accurate and timely data entry.
• Assist in the preparation of study reports and presentations.
• Assist in the management of Trial Master File.

Site Management:

• Assist in the qualification, initiation, and closeout of clinical trial sites.
• Monitor site performance and address any issues that may arise.
• Assist with on-site monitoring, if needed.
• Travel: Willingness and ability to travel domestically and internationally as required for site visits, investigator meetings, and conferences.

Qualifications:

• Bachelor's degree or higher in a life science field (e.g., biology, chemistry, nursing, or related discipline).
• Understanding of GCP, ICH guidelines, and regulatory requirements.
• Excellent organizational, communication, and interpersonal skills.
• Proficiency in using clinical trial management systems (CTMS) and other relevant software.
• Ability to work independently and as part of a team in a fast-paced environment.
• Strong problem-solving skills.
• Ability to manage multiple projects and priorities.

Benefits:
SMSbiotech offers a competitive compensation and benefits package, including health insurance, vision, dental insurance, and a 401k plan.