Senior Clinical Operation Specialist
1 month ago
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 Sr. Clinical Operations Specialist or Manager of Clinical is responsible for the support of day-to-day aspects of running clinical studies, including, but not limited to, study development/initiation, study management, study monitoring, and study close-out in accordance with applicable Standard Operating Procedures (SOPs) and the International Conference on Harmonisation's (ICH) guidelines for Good Clinical Practice (GCP).
Specific responsibilities:
Clinical Study Execution/Management / Clinical Operations
- Support study start-up, execution and study close out activities
- Responsible for day-to-day management of electronic Trial Master File (eTMF)
- Ensure all essential documents are maintained in clinical Trial Master File (TMF) in accordance with Regulatory and Compliance standards
- Assist other Clinical Operations tasks as requested
- Develop and refine study monitoring plan
- Responsible for all aspects of study site monitoring, including, but not limited to conducting in-person/remote monitoring, authoring site/monitoring visit letters and reports, verifying source documents, resolving queries, etc.
- Conduct follow-up visits with sites, as needed, to resolve problems/issues and to ensure that studies are being carried out in accordance with the protocol
- Validate compliance of data with protocols, GCP (Good clinical Practices)
- Track and collate reported site protocol deviations, adverse events, and unanticipated adverse device effects, and communicate that to responsible internal parties at Cardiosense
- Track reporting of reportable events to the IRB (local and/or central IRB) and collaborate with internal Cardiosense stakeholders for internal review
- Conduct remote EDC data monitoring
- Assist with EDC database lock and EDC data export at end of study
- Bachelor's degree in a life science-related field with or 4+ years of relevant clinical research experience
- 3-5+ years of direct clinical monitoring experience
- Clinical research certification (ACRP or SOCRA/CRA Certification) preferred
- Experience with clinical study regulatory document/eTMF management and EDCs
- Excellent written and verbal communication, interpersonal, and analytical skills
- Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
- Successfully hired candidates will be subject to criminal background checks and pre-employment drug-screening in accordance with requirements at clinical sites
Travel Requirements
Ability to travel anticipated to be 25-30% on average, but may occassionally exceed based on clincial needs
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.
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