Clinical Operations Associate
Chicago /
Clinical /
Hybrid
/ Hybrid
Cardiosense is a digital health company that operates at the intersection of wearable technology and artificial intelligence to improve patient health. Our mission is to use physiological waveform data to predict cardiac illness and enable early interventions so people can enjoy healthier, longer lives.
To achieve our mission we are building a physiological waveform AI platform to develop predictive biomarkers to detect and manage cardiac disease. The company has developed a suite of novel digital tools, multi-sensor devices, and analysis algorithms for use by care providers to detect clinical worsening earlier, inform personalized therapy, and improve patient outcomes.
Our team brings together experts in data science, electronics, and healthcare and has partnered with leading healthcare and academic institutions to introduce the next generation of patient waveform monitoring and analytics solutions.
ABOUT THE ROLE:
The Clinical Operations Associate (COA) is responsible for assigned aspects of clinical study support including, but not limited to, monitoring and site management in accordance with applicable Standard Operating Procedures (SOPs) and the International Conference on Harmonisation’s (ICH) guidelines for Good Clinical Practice (GCP). The COA is responsible for study site management and relationships to assure and assess that sites conduct the study protocol consistent with regulatory compliance, data reliability, and the proper care and treatment of study participants. Additionally, they will be a resource to the clinical site for study support, study training, and liaise with the sponsor team to assure smooth study and successful trial execution. The Clinical Operations Associate represents the organization in a professional and collegial manner and reports to the Director of Clinical Operations.
WHAT YOU'LL BE DOING:
- Provide study support including training, re-training, or acts as a general resources to assure smooth trial execution
- Recognize sites for enrollment success and supports and troubles-shoots solutions with sites when enrollment is not meeting anticipated targets
- Ensure compliance with standard protocol and regulatory and ICH GCP obligations in assigned aspects of clinical site monitoring, such as site initiation, routine monitoring, maintenance of study files, study close out, and retrieval of study materials
- Complete on-site and remote monitoring activities in compliance with the Clinical Monitoring Plan, including source document verification, as required
- Ensure the integrity of data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations, and internal SOPs
- Participate in audit preparation and follow-up activities, as needed
- Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations
- Verify proper management and accountability of Investigational Product
- Write and submit reports of investigational site findings and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate
- Manage essential documents as required by local regulations and ICH GCP before, during, and after a clinical study; assist with resolution of investigational site/data queries
- Submit protocols and supporting documents to internal and external regulatory bodies (i.e., Institutional Review Board), ensuring trials are consistent with approved proposals to open new studies and/or study amendments.
- Manage and maintain electronic regulatory files (e.g., staff resumes, licenses, training certificates, equipment receipts, investigation logs). Reviews documentation as needed to support regulatory filings and maintains research files and documentation required by regulations.
KNOWLEDGE, SKILLS and ABILITIES:
- General knowledge of regulatory requirements & GCP
- Ability to multi-task and deal with shifting priorities
- High proficiency with full Microsoft applications
- Strong spoken and written communication skills; fluency in English
- Strong interpersonal, collaborative, and time management abilities
- Excellent organizational skills; accurate and detail-oriented
EDUCATION and EXPERIENCE:
- Bachelor’s degree in a life science-related field
- 2 years’ experience in a clinical trials research environment required
- Experience with clinical study regulatory document management
- Experience with executing clinical studies/trials
- Experience with wearable/device studies is highly preferred
- Experience working in cardiovascular trials is preferred
- Valid driver’s license required
This role requires travel to clinical trial sites, ranging from 25-30%.
Cardiosense is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, religion, disability status, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
