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Medical Research Director
1 month ago
We are seeking a highly skilled Medical Research Director to lead our clinical trials initiative in Providence, RI. As a key member of our team, you will be responsible for overseeing the conduct of clinical investigations, ensuring adherence to protocol requirements, and protecting the rights and welfare of study subjects.
Key Responsibilities:
- Oversee the conduct of clinical trials, including the oversight and ethical conduct of the study, maintaining integrity of the study design, and direction of the research team
- Evaluate patient eligibility for clinical trials as per protocol
- Review and discuss study protocols and obtain informed consents from patients
- Meet with patients during designated study visits to perform assessments, including physical examinations and data collection
- Monitor all safety variables, including adverse events, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medications as per protocol, and un-blinding requests
- Use proper medical judgment in the interpretation and decision-making as it relates to the investigational study
- Review, approve, and ensure timely reporting of eCRFs, protocol deviations, and Serious Adverse Events (SAE)
- Ensure accurate documentation of study-related procedures
- Ensure proper use and storage of Investigational Product
- Ensure prompt reporting of all unanticipated problems or injuries to IRB, Sponsor, or delegated representative
- Meet with FDA, IRB, Sponsors, CROs, or their delegated representatives as needed throughout the study
- Review and discuss any medical or protocol-related concerns with medical monitors
- Attend Investigator Meetings and other study-related meetings
- Review and approve Clinical Study Agreements
- Work with Sub-investigator(s), Clinical Research Coordinators, and key study personnel in overseeing the execution of study protocols
Requirements:
- Medical Degree and broad-based post-graduate experience
- Board certification in Neurology or Gerontology preferred
- Medical License within the State of Rhode Island
- A minimum of 3 or more years of experience in a clinical research position (Preferred)
- Principal Investigator of Clinical Trials: 3 years (Preferred)
We offer a competitive salary and benefits package, including medical, dental, vision, flexible spending accounts, employer-paid long-term disability and life insurance, short-term disability, accident and critical illness insurance, voluntary life and long-term care insurance, legal shield, employee assistance program, and various discount programs. We also offer a 401(K) plan with a 4% employer match that is immediately vested, 16 days of PTO per year, 17 days after the first year of full-time employment, and 9 paid holidays.
K2 observes a four-day work week, Monday through Thursday, for full-time employees. Fridays are non-working days unless required by business needs.