Clinical Study Coordinator
Do you have experience coordinating clinical research/studies and are looking for a new challenge in the healthcare industry that can have a positive health impact for millions of people? Do you love to face difficult problems head on, and thrive in a fast-paced environment? If so, we would love to speak with you about the Clinical Study Coordinator role at Casana (formerly Heart Health Intelligence).
Casana is revolutionizing healthcare by creating clinical-grade technology that unobtrusively checks a person’s health in their home. Backed by a top-ranked VC and led by a CEO who founded and led a tech unicorn to a successful IPO, Casana is designing and building the home health platform of the future. We are seeking bright, driven candidates to join our team, shape our culture, and create technology that transforms healthcare.
We offer competitive salaries, excellent benefits, unlimited paid time off, and an opportunity to work in a fast-paced, purpose-driven, collaborative environment.
We are looking for experienced clinical study or research coordinators that have regulatory (FDA and GCP) experience and excellent project management and interpersonal skills. In this role, you will work on multiple studies being run internally and with external clinical partners. You must be able to work independently and be open to taking on new responsibilities. Your efforts will help us revolutionize home health care with products that are clinically validated, optimize the efforts of clinicians managing patients with chronic disease, and meet FDA regulatory requirements. This position is based in Rochester, NY.
- Support creation of study protocols and documentation, IRB submissions, and initiation of clinical studies in collaboration with Casana’s clinical resources
- Oversee and facilitate the smooth running of clinical studies
- Collaborate with Primary Investigators (PIs), including support of subject recruitment, monitoring of data collection and processing, and ensuring adherence to study protocols
- Ensure all studies meet regulatory compliance and ethical standards in coordination with Casana’s Director of Quality Management
- For internally run studies, interact with study participants, including obtaining consents, administering questionnaires, and monitoring participation
- Ensure all supplies and equipment for studies are available and working correctly
- Maintain study records per FDA and GCP guidelines
- Manage data collection according to regulatory requirements
- Manage clinical study tools, including electronic data capture and other tools
- As needed, interface with contract research organizations (CROs) that are involved in running external clinical studies for Casana
- Propose and contribute to new processes, procedures, and tools that can improve the Casana’s ability to run effective, compliant, and efficient clinical studies
Required Skills and Experience
- 2+ years in healthcare
- 2+ years in a research or study coordinator role
- Analytical mindset
- Attention to detail
- Ability to work in an environment that requires self-education and self-direction
- Demonstrated project management skills
- Familiarity and comfort working with technology
Desired Skills and Experience
- Associates degree in Nursing or related field
- 5+ years in a research or study coordinator role
- Cardiology nursing background
- Medical device research experience