Clinical Operations Specialist
Aziyo currently has post market clinical programs in a number of therapeutic areas including cardiovascular and orthopedics in support of the Company’s overall goals. The Clinical Operations Specialist is responsible for all operational aspects of clinical trial execution to include initial clinical site outreach through site initiation, site monitoring and study closeout.
Position reports to Vice President, Clinical Development
Essential Duties & Responsibilities
• Compile regulatory submission documentation and maintain organized regulatory and clinical files
• Assist with clinical study protocol development, clinical site selection and training, data collection, data analysis and study report development
• Perform clinical data monitoring activities to ensure data collected is accurate and complete
• Maintain clinical databases/systems and other ad hoc tasks associated with clinical research as required
• Ensure compliance with Good Clinical Practices, all applicable company guidelines, SOPs, laws, and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners
Bachelor’s degree in a scientific discipline from an accredited college or university required
Experience and Skills
• Minimum of 3 years of experience in the biotech/pharmaceutical industry
• Demonstrated strengths in planning, organization, time management, problem solving, and attention to detail
• Experience in clinical trial execution in an academic or industry setting
• Strong organizational skills, attention to detail and the ability to manage multiple priorities and produce accurate and timely work in a highly-regulated environment
• Ability to work individually, within a multi-disciplinary team and with external vendors and clinicians
• Excellent interpersonal communication and presentations skills with the ability to communicate effectively with clinical sites and
• Ability to quickly learn and implement new information, standards, regulations, tools, methods or software as it relates to clinical study execution and data collection
• Basic understanding of US healthcare environment, clinical research process, FDA and other federal regulations and ethical guidelines
• Ability to travel (up to 50%)
Aziyo offers competitive compensation and benefits packages, which include:
Medical, Dental, Vision, Disability, Life and 401k with employer matching program.
Aziyo Biologics is an equal opportunity employer committed to affirmative action and diversity in our workforce.