Senior Clinical Research Associate

Key Skills

Aartificial intelligence, Adobe Creative Suite, Algorithms, Analytical and Problem solving, Data science techniques, Database, Environmental, Google Cloud Platform (GCP), Health and Safety, Hypothesis testing, Logistic Regression, Microsoft Office suites, Microsoft-Excel

Job Description

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:

Reporting to the Director of Clinical Operations, the person in this role is responsible for the management of day-to-day aspects of investigational site activities on assigned clinical studies, including but not limited to study development, execution, monitoring, and close-out. The CRA should ensure compliance with international guidelines, local regulations and corporate policies and procedures. Successful candidates will be forward-thinking, anticipate needs and be able to work well in a fast-paced environment, either independently or as a collaborative team.

Key Responsibilities:

• Participate in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification visit and site initiation visit)
• Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Cardiosense internal SOPs, and US and regulations
• Investigate discrepancies and participate in the development of processes to minimize possibility of recurrence during study conduct and closeout
• Assist in identifying opportunities and proposing solutions to improve efficiencies within and across related functional areas
• Participate in site initiation visits; train site personnel on sponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation.
• Conduct clinical site and data monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study
• Author and complete monitoring visit reports
• Assess all data documentation, reports, records, transcripts, exam results for consistency with case report form/electronic data capture and/or source documentation and determine if clinical study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information) and regulatory requirements.
• Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
• Validate investigational device accountability by tracking the history of investigational devices from Cardiosense to the field sites and through final disposition.
• Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Clinical Operations (e.g., Contracts), and recommend and develop process improvements.
• Contribute with development and delivery of trainings; GCPs, protocols, and database, compliance, device accountability, and adverse event reporting.
• Draft/amend informed consent documents, case report forms (CRFs), and CRF completion guidelines.

Job Qualifications

• Bachelor's Degree or equivalent in Life Sciences or related field with at least 5 years previous field monitoring experience required or 3 years equivalent learning in a working environment with hands-on clinical research experience encompassing all aspects of the clinical process and clinical monitoring experience, including 1) Cardiovascular device trials; and 2) Cath lab, operating room and/or intensive care unit familiarity required
• Excellent written and verbal communication, presentation, interpersonal, and analytical skills required
• Good problem-solving and critical thinking skills
• Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
• Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
• Good computer skills in MS Office Suite, including Word, Excel, Adobe
• Experience with electronic data capture (EDC)
• Good written and verbal communication skills and interpersonal relationship skills
• Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification) preferred
• Ability to travel up to 75% required