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Clinical Research Physician- PI
2 months ago
Clinical Research Physician – New Haven, CT
Overview
This is an exciting opportunity to work at the cutting edge of clinical drug development as we work to accelerate new groundbreaking therapies to provide better outcomes for patients and their families. We are a highly regarded and growing clinical research and medical imaging organization with major programs in pre-clinical and clinical spaces.
This position may be a good fit for a physician who has an interest in early phase clinical trials. We are seeking a physician to join our ongoing clinical research program at our outpatient facility located in New Haven, CT. Our Clinic is a research-dedicated facility (with no fees or insurance required/accepted), in which we carry out world-renown research in Parkinson Disease, Alzheimer Disease, and other disorders. The clinical staff comprises physicians, advanced practice providers, nurses, nuclear medicine technologists, and coordinators. The successful candidate will assume the responsibility as a principal investigator or sub-investigator for single-site and multi-site trials, while providing medical oversight for molecular imaging center studies.
This role involves overseeing study conduct, ensuring subject safety, and collaborating with interdisciplinary teams (including Project Management, Chemistry, Regulatory, Quality Assurance, Image Analysis, Data Management, Medical Writing, etc.) to achieve project goals. Major responsibilities include medical oversight of the clinical and imaging activities, community physician outreach, research participant evaluations, supporting development of clinical trial documentation, informed consent and eligibility confirmation, trial-related procedures, and administration of rating scales. Additional opportunities include participation in national and international meetings, scientific publications, and multidisciplinary research projects.
Essential Functions
- Assumes the role and responsibilities of principal investigator/sub-investigator/site physician and provides overall supervision and management of studies in the Clinic.
- The investigator conducts and coordinates daily clinical trial activities according to ICH/FDA/GCP guidelines, local regulations, study protocol and company policies and processes.
- Provides medical and clinical oversight of all aspects of work performed within the Clinic.
- Provide oversight and ensures proper delegation of duties to appropriate qualified staff.
- Ensures that the quality standard of clinical work and product is met.
- Interacts with local neurologists, physicians, community outreach groups, and international medical/scientific experts.
- Identifies eligible participants and manages recruitment for multiple (often competing) studies.
- Educates potential or enrolled participants on trial opportunities.
- Obtains, compiles, and records patient medical data, including health histories, progress notes, and results of physical examination.
- Performs or oversees structured evaluations and procedures in clinical trials
- Monitors subjects for adverse events and initiates appropriate actions as per clinical judgment.
- Reviews and evaluates safety data; evaluates and report safety reports, protocol noncompliance, and any other protocol-specific reports.
- Provides clinical/scientific leadership within Invicro and the New Haven Clinic and contributes to clinical strategy and clinical plans within business unit and company priorities.
- Collaborates with operational and management teams to ensure department goals are met.
- Other duties as required.
Qualifications
- MD or DO degree with a valid license to practice medicine
- Must have, or clearly be able to obtain, an active CT medical license.
- Eligibility to serve as Principal Investigator for Clinical Trials in US.
- Demonstrate the proper education, training, and experience to conduct a clinical investigation.
- Advanced knowledge of treatment and drug interactions.
- Ability to build rapport with participants, neurologists, and biopharmaceutical sponsors.
- Strong leadership qualities.
- Strong attention to detail.
- Possess strong interpersonal skills when interacting with participants and working with multifunctional and interdepartmental management teams.
- Experience and understanding of effective electronic communication methods (i.e., Email, Video Conferencing, Slack, etc.)
- Computer competency including a strong knowledge of computer applications and proficiency in Microsoft (MS) Office and the ability to learn different software programs.
Preferred, But Not Required
- Experience as a clinical study principal investigator or sub-investigator.
- Experience in the conduct of clinical pharmacology studies.
- Working knowledge of clinical research methodology including latest developments in relevant areas of biomarkers, efficacy measures, diagnostic practices, study designs, safety evaluations and regulatory standards.
- Knowledge of principles of molecular imaging.
- Working experience in a clinical research organization and/or at least 5 years of experience working in a scientific, research, or healthcare environment.
- Experience with patients affected by CNS disorders (i.e., Neurodegenerative disorders, Movement disorders, Psychiatric disorders, Multiple Sclerosis, etc.) or oncology.
Other
- This position follows a Monday to Friday schedule: 8am-5pm. It requires alternative or additional hours and (weekends/evenings/nights) to provide adequate study activity coverage.
- This position is located at our New Haven clinic and is ineligible for hybrid or remote work opportunities.
- Occupational Exposure/Risk Potential - Bloodborne pathogens or bodily fluid (Applicable)
- Occupational Exposure/Risk Potential – Ionizing Radiation Exposure (Applicable)
Calyx and Invicro agree to combine and create a global leader in medical imaging and software solutions for the clinical research community
Calyx, a leading technology-enabled provider of Medical Imaging services and IRT/RTSM (Interactive Response Technology/Randomized Trial Supply Management) to drug developers, and Invicro, a next-generation quantitative imaging biomarker company and pre-eminent development partner to pharma sponsors, have agreed to combine their businesses. This complementary combination will create a new global leader in the provision of medical imaging solutions and development services to the clinical research community.
The enlarged Group (“Group”) formed through this strategic combination will see 100% of Invicro being acquired by Calyx from its current owner, REALM IDx, Inc. The transaction is subject to regulatory filings and customary closing conditions and is expected to complete in Q2 2024.
