Study Start Up Associate II - Medical Device

As a Study Start Up Associate II, you will conduct clinical trial site start-up activities, including IRB submissions and approvals, site informed consent form customizations and negotiations, and essential regulatory document collection. You will work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection. You will also manage multiple sets of essential regulatory documents across several studies and division portfolios.

What You Will Do

Your responsibilities will include working independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection, managing multiple sets of essential regulatory documents, partnering with clinical sites to support the negotiation and customization of Informed Consent Form (ICF), and developing and fostering clinical research site relationships.

Why It Might Be a Fit

We are looking for someone with a minimum of 3 years' experience in clinical/scientific research and medical device experience, specifically clinical study site start-up experience within the US. You should be able to multi-task, support several studies and/or personnel simultaneously, and work in a very fast-paced environment. You should also be comfortable interacting with clinical research site personnel via phone and email.

Requirements

• Bachelor’s Degree, or an equivalent combination of experience and education
• 3+ years’ experience in clinical/scientific research and medical device experience, specifically clinical study site start-up experience within the US
• Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast-paced environment
• Ability to work in a team environment and possess clear, concise communication & presentation skills – written and verbal
• Must be comfortable interacting with clinical research site personnel via phone and email

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways