Our Regulatory Coordinators hold a pivotal role, tasked with ensuring that all aspects of or various clinical trials adhere to regulatory requirements. You will manage multiple sites and studies simultaneously, and be responsible for a range of duties, so the ideal candidate will possess a keen attention to detail and meticulous organizational skills. You will be responsible for regulatory updates, preparing and submitting necessary documentation such as IRB submissions, and maintaining regular communication with study sponsors. You will also provide crucial support and training to clinical research staff, contribute to SOPs for compliance, participate in audits, and review regulatory documents for accuracy and adherence to standards. Additionally, the Regulatory Coordinator will need to be well-versed in regulatory trends and assess the impact of regulatory changes on current and future trials. The role is vital for maintaining integrity of clinical research projects and streamlining processes to prevent delays, improving the efficiency of clinical trials. You will ensure that all trial documentation is thorough and readily available for inspections, fostering smooth operations, effective collaborations, and compliance with all necessary guidelines and procedures. 

Key Responsibilities (included but not limited to)

Serve as a liaison between the research team, regulatory authorities, and sponsors

Foster effective communication and collaboration within the internal clinical operations team

Facilitate the submission and training of clinical trial protocols, amendments, and informed consent documents

Manage Institutional Review Board (IRB) communications

Create and maintain regulatory binders and all other essential documents

Facilitate training on all relevant study documents

Regularly collaborate with investigators, sponsors, and Institutional Review Boards (IRBs) to ensure compliance with regulations and protocols

Ensure adherence to all applicable regulatory requirements

Oversee the preparation and submission of regulatory documents to sponsors

Ensure that all records are organized and available for inspection and audit ready at all times

Any other duties as assigned by manager