Contract - Clinical Research Administrator
Gelesis is a clinical stage medical device company developing a new category of therapy to safely treat overweight, obese and diabetic patients. Obesity is the world’s largest health challenge affecting a greater number of people than any other disease on the planet. The sequela from obesity includes diabetes and cardiovascular events, which can ultimately lead to death. Gelesis100, our lead product, is a first-of-its kind smart pill which is designed to act mechanically in the stomach and small intestine to increase satiety and decrease hunger, resulting in reduced caloric intake and weight loss. Gelesis100 is administered orally as a capsulated device.
- Compile and file new protocol amendments, annual reports, safety updates, etc.
- Coordinate review process of various clinical operations documents/materials (i.e., protocols/amendments, informed consent forms, SOPs)
- Prepare and review budgets, contracts, purchase orders to support clinical operation team
- Provide administrative support to the Gelesis team (schedule teleconferences/meetings, calendar, travel etc)
- Review essential documents and file per regulatory guidelines.
- Work with outside vendors and investigators to support clinical operation team.
- Minimum of one year experience in daily operations of clinical research is required
- Excellent written and oral communication skills.
- Strong time management and project management capabilities.
- Ability to problem solve when difficult issues arise.
- Detail-oriented and organized.
- Computer skills, including Microsoft Word, Excel, and PowerPoint.
- Knowledge of FDA regulations, and ICH guidelines preferred.