Clinical Regulatory Affairs Specialist

WHOOP is an advanced health and fitness wearable, on a mission to unlock human performance. WHOOP empowers its members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives.

As the Clinical Regulatory Affairs Specialist, you will play a critical role in managing essential documentation and regulatory submissions that are key to our clinical trials' success. Your responsibilities will span from preparing and submitting IRB documentation to ensuring the proper setup and maintenance of e-TMF systems throughout the trial lifecycle.

You will ensure the success of clinical trials by overseeing the submission of regulatory packages, managing IRB approvals and amendments, and handling ongoing updates of study documents. Your expertise will be crucial for ensuring compliance with local and international regulations, facilitating seamless coordination between study sites, regulatory bodies, and internal teams. Additionally, you will take ownership of study document reconciliation, ensuring that all records are complete at the conclusion of trials.

On the operational side, you will manage the setup and periodic review of electronic Trial Master Files (e-TMF) and ensure study documentation is properly maintained across multiple sites. You will collaborate with cross-functional teams to ensure that protocol revisions, Clinical Study Reports (CSR), and safety specifications are thoroughly documented and submitted on time. You are responsible for ensuring a high level of accuracy and quality control in all documentation-related processes.