Project Coordinator; Site Activation and Maintenance

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Project Coordinators to join our Site Activation and Maintenance (SAM) team
. This position works both independently and collaboratively with a team to meet common goals and plays a key role in the clinical trial management and study start-up process  you want to build on your foundational knowledge and take the next step in your clinical research career, then this is the opportunity for you.

• Communicate with research sites (doctor's offices, universities, hospitals, etc.) to collect all essential documents required before the site begins to screen patients to participate in the clinical trial;
• Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF);
• Collect, review, organize, and assemble regulatory start-up submissions (including submissions to Institutional Review Boards (IRB);
• Maintain timelines for study start-up through both internal and external collaboration;
• Gain exposure to multiple therapeutic areas including but not limited to Oncology/Hematology, Cardiovascular, and Metabolic;
• Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements; and
• Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.

• Complete independent learning modules, interactive exercises, and team workshops through the core curriculum;
• Gain exposure to real-world tasks through a robust mentoring program; and
• Join other professionals revolutionizing efficient and seamless study start-up to advance clinical trials.

• Bachelor's degree required (preferably in a Life Sciences field);
• Some experience within the healthcare or clinical research field preferred;
• Excellent organizational and prioritization skills;
• Knowledge of Microsoft Office;
• Great attention to detail and excellent oral and written communication skills.

Travel: None