Job Description
About Calyx Our mission is to shape the future of clinical research. With decades of experience and the brightest minds in the industry, we help the global biopharmaceutical industry bring new, advanced medical treatments to market, faster.
We seek to change the world, and with the support of our teams across the globe, we flourish together. At Calyx, we are one team. We learn, grow and win together.
Are you ready to help change the world?
Apart from job satisfaction, we can offer you: HEALTH: - Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA) and Health Savings Accounts (HSAs)
YOURSELF :
- Paid time off policy including holidays and sick time
- Internal growth and development programs & trainings
WEALTH: 401(k) program, life & accident insurance and disability insurance
About the role 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 board-certified/eligible Neurologist or Psychiatrist who has an interest in 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.
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.
- 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 - Specialty training and board certification/eligibility in Neurology or Psychiatry
- Sub-specialty training in CNS disorders preferred.
- 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)
Come as you are. We're proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, colour, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Job Tags
Holiday work, Work experience placement, Local area, Remote job, Flexible hours, Night shift, Weekend work, Afternoon shift, Monday to Friday,