Clinical Research Coordinator
The Role
Akili is looking for a full-time Clinical Research Coordinator to join our growing Clinical Research team in Boston. You will support the planning and timely execution of multiple multi-site clinical trials of Akili’s digital medicine products from start-up to close-out. This is an in-house role requiring both remote and in-office work.
Responsibilities
- Shipping, logging, and tracking study product
- Providing technical assistance to study sites and staff
- Providing real-time monitoring of study status, including tracking to plan (enrollment) and compliance
- Providing remote training for study staff (site initiation visits)
- Ensure familiarity with clinical protocols, study plans, timelines, and procedures
- Creating study-related documents for internal and external use
- Maintaining established documents and records
- Coordinate cross-functionally to ensure on-time device preparation and shipment
- Keep meticulous logging of device records
- Manage clinical supplies
- Obtain and maintain licenses
- Support the clinical team toward audit readiness
- Support clinical trial managers in day-to-day activities
- Support IRB submissions
Qualifications
- Minimum education: B.S. in a scientific or health-care related discipline
- Experience: 2+ years in clinical operations for a medical device, pharmaceutical and/or biotechnology company or experience in a similar role
- Highly detail-oriented and organized
- Excellent written and oral communication skills
- Ability to prioritize tasks and set deadlines
- Strong interpersonal skills and comfortable in interactions with CROs, site study staff, and external monitors
- Tech savvy with an ability to embrace mobile app-based software as a medical device
- High degree of computer literacy – Proficient in Microsoft Word, Excel, and Google Suite
- Familiarity with Good Clinical Practices, HIPAA, and the conduct of clinical research and IRB submissions
About Akili
At Akili Interactive, our mission is to ignite new hope for those living with cognitive impairment. We’re bringing together world-class neuroscience with the latest technology and video game entertainment to create a new class of digital medicines, delivered through captivating video game experiences. We are out to prove that effective medicine for serious illnesses can also be fun and engaging.
Our flagship product, EndeavorRx, is the first ever FDA-cleared prescription treatment delivered through a video game to treat children living with ADHD. This is only the beginning, as we continue to boldly challenge the status quo of today’s medicine.
Diversity and Inclusion
Diversity and inclusion are incredibly important to all of us. We are committed to hearing all voices. Akili Interactive provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetics, sexual orientation, gender identity or gender expression.