Clinical Study Start-Up & Monitoring Specialist (Cardiovascular)

About the Role

We are seeking an experienced Clinical Study Start-Up and Monitoring Specialist specializing in cardiovascular studies to join a leading global medical device manufacturer. This position involves overseeing study start-up procedures, including review of informed consent forms and ensuring regulatory adherence. You will manage essential study documentation, monitor compliance with Good Clinical Practice (GCP), and contribute to audit preparedness.

Key Responsibilities

• Identify and investigate inconsistencies in study documents using clinical protocols and GCP expertise, implementing preventative measures across study phases.
• Perform in-house document reviews and support internal and external audits by regulatory bodies such as the FDA, DEKRA, and PMDA, ensuring clinical trial master file compliance with GCP, SOPs, and regulations in the US and globally.
• Evaluate existing processes, identify inefficiencies, and recommend improvements to enhance cross-functional operations.
• Collaborate with multidisciplinary teams including clinical data management and field staff to manage queries, review data, and resolve issues.

Required Qualifications

• Bachelor’s degree or equivalent qualification in a relevant discipline.
• 2 to 4 years of clinical research experience, with strong knowledge of clinical study processes, monitoring techniques, and applicable regulations.
• Proven understanding of compliance standards ensuring protection of human subjects’ rights and well-being throughout clinical research.

Additional Details

• Compensation: $58.95 per hour
• Contract length: 9 months
• Location: Irvine, California - Hybrid schedule with 3 days onsite (Monday to Wednesday) and 2 days remote (Thursday and Friday). Fully remote options available for candidates outside the local area.
• Travel: Approximately 25%, initially local and potentially domestic travel in the future.