Job Purpose
Essential Functions
- Adjudication of Cardiodynamic ECGs: Conduct timely and blinded interpretation and measurement of cardiodynamic ECGs consistent with the accuracy and precision required at Celerion for regulatory submission.
- Safety ECG Review: Provide consultative services involving the review of safety ECGs in collaboration with the Principal Investigator (PI) or their designee to aid in subject management decisions.
- Holter Review: Analyze continuous digital Holter recordings for potential dysrhythmias that would impact subject safety.
- Consultation Availability: Provide expert consultation on cardiovascular, clinical, or core laboratory specific findings, addressing questions from team members that require specialized cardiology insights and recommendations.
- Adverse Event Notification: Promptly alert the Principal Investigator (PI) or their designee to any potentially serious adverse clinical events identified during the review of cardiovascular data.
- Core Laboratory Meetings: Actively participate in monthly core laboratory staff meetings to discuss salient issues, provide educational insights, and offer feedback to enhance team collaboration and performance.
- Compliance Adherence: Ensure strict compliance with all procedure guidelines (WIs), standard operating procedures (SOPs), and training requirements.
- Continuing Education and Licensing: Maintain all continuing education and licensing requirements as mandated by the state in which they are licensed to practice medicine.
- Quality Assessment Participation: Engage in annual quality assessment exercises to ensure maintenance of clinical competence in ECG reading skills and evaluate intra-reader and inter-reader variability.
- Process Improvement Contributions: Provide valuable input and recommendations into core laboratory processes and procedures designed to enhance accuracy, precision, and operational efficiency.
- These functions are integral to support patient safety, preserve data integrity and uphold the outstanding reputation enjoyed by Celerion as an industry leader in early phase clinical trials.
Knowledge/Skills/Education/Licenses
- Educational Background: Licensed physician in good standing with board certification or equivalent in cardiology
- Experience: (Preferred) 1-2 years of experience in pharmaceutical clinical research, the biotech industry, or as a member of a Contract Research Organization (CRO).
- Communication Skills: Excellent verbal and written communication skills to facilitate effective collaboration with colleagues, departments, and clients.
- Technology Proficiency: Demonstrate strong computer skills with the ability to troubleshoot general issues. Proficient in Microsoft Word, Excel, PowerPoint, Outlook, Veeva, and department-specific software, ensuring seamless integration of technology into daily operations.
- Independence and Organizational Skills: Display a high level of organization and the ability to work independently effectively managing multiple priorities.
- Problem-Solving: Exhibit solid problem-solving and decision-making skills, navigating complex challenges with confidence and efficiency.
- Innovation: Exhibit an inquisitive demeanor and a desire to develop innovative approaches pertaining to core laboratory efficiency and cardiovascular service offerings
- Passion for Science: Strong commitment to learning and advancing scientific knowledge within the field of new drug development and regulatory guidance.
- Continuing Education: Maintain and enhance subject matter expertise by engaging in ongoing education programs and webinars related to early phase pharmaceutical research.
- Availability for occasional on-site, telephone, or email consultations is required.