The Principal investigator will be responsible for overseeing a number of sponsor initiated clinical research trials at both of CMR’s sites. As such, the physician is responsible for promoting good clinical practice in the conduct of clinical investigations. Ensure adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of data generated at the site and directing the conduct of the clinical investigations according to federal and state regulations and guidance documents.
Reports to CMR Medical Director
Works with the following:
Other Principal Investigators, Sub-Investigators & Physicians
Director of Clinical Operations, Training and Auditing
Director of Business Development
Clinical Research Coordinators
Patient Recruitment Coordinators I and II
Monitors, CRAs, and Sponsor/CRO representatives
Clinical Research Team Members
Study Subjects and Potential Study Subjects
Provides investigator qualifications and agreements by:
Maintaining a current and up-to-date resume
Maintaining current licensure to practice
Provides the sponsor and IRB with documentation of credentials as requested.
Demonstrating the proper education, training, and experience to conduct the clinical trial investigation.
Assume responsibility for the conduct of the clinical trial investigation.
Completing required study trial training and signing the following:
Form FDA 1572
Sponsor contracts, as necessary
Disclosing conflicts of interests as described in the regulations.
Ensures protocol compliance.
Ensures initial and ongoing review by a duly constituted IRB.
Determines adequate resources are available to conduct the clinical trial.
Ensuring he/she has adequate time to conduct and supervise the clinical trial.
Ensuring there is adequate qualified staff to conduct the clinical trial.
Oversee study start-up training of staff.
Manage the medical care of subjects.
Ensuring that a qualified physician is responsible for all trial related medical decisions.
Perform duties such as physical exams, review of medical and medication history, read ECG tracings, review of subject eligibility of study criteria, review of safety and other lab results and assign clinical significance to results, review and assign causality and severity to any adverse events that subjects experience. ?
Assessing the subjects compliance with the test article and follow-up visits.
Assessing the subject’s response to therapy.
Evaluating adverse events and ensuring the medical care is provided to a subject for any adverse event.
Informing a subject when medical care is needed to treat an current illnesses.
Informing the subject’s primary physician about the participation in the trial.
Review’s safety reports relevant to study drug.
Protects the Rights and Welfare of Subjects.
Reporting all serious adverse events immediately to the sponsor and IRB.
Obtaining a signed and dated informed consent from the subject or subject’s legal representative prior to initiating any study-related procedures.
Informing the subject or legal representative abut all aspects of the clinical trial.
Ensuring Validity of the Data Reported to the Sponsor.
Ensuring the accuracy, completeness, legibility and timeliness of the case report forms.
Ensuring the case report forms accurately reflect source documents.
Endorsing changes or corrections to a case report form.
Ensures Documentation of Study Related Procedures, Processes and Events.
Maintaining trial documents as required by the regulations and sponsor for the appropriate timeframe and under secure conditions.
Providing study reports as requested by the sponsor, IRB and regulatory authorities.
Ensures the Proper Use and Storage of Investigational Agents
Assuming responsibility for the investigational product at the trial site.
Ensuring the proper use and storage of the investigational product at the trial site.
Assigning responsibility to the appropriate research pharmacy personnel.
Directs Operations for Assigned Trials.
Meeting regularly with the research team to discuss subject participation and protocol progress.
Ensuring that all research staff are informed about the protocol and investigational agents.
Participating in monitoring visits and audits as appropriate.
Delegating authority at the site appropriately.
Maintaining a list of qualified persons and their corresponding trial-related delegated duties.
Evaluation of Study Participation.
Participate in development of the study participation strategies as requested.
Review identified protocols for applicability to site’s capabilities and decide on accepting or declining the clinical trial.
Assist in study questionnaires as requested.
Meet with CRAs/Monitors during Pre-Study Visits.
Work using good clinical practices in the conduct of clinical investigations and maintains compliance with protocol and regulatory requirements. Also maintains compliance with any state, local and OSHA guidelines or regulations. Also, uses precaution to assure human subject protection.
Occasional overnight travel.
Medical Degree and Board Certification, MD or DO
Current Medical Licensure in Connecticut
Prefer Clinical Research Experience
Understanding the Customer (Sponsors, CROs)
Understanding the Pharmaceutical Investigational New Drugs (“IND”) Industry
In-depth knowledge of research regulations and standards.
Proficient in common research software used by sponsors/CROs to communicate with sites.
Additional Salary Information: Based on experience in medical practice and clinical research.
Chase Medical Research, LLC brings over 16 years of experience in clinical research and two clinical investigator site locations (Waterbury & Hamden, CT), over 300 trials conducted, and affiliations with over 10 medical groups of various specialties. We are multi-therapeutic with continuous emphasis on building medical relationships in our community and building our database of volunteers. Our rel...ationship with these key partners (physicians and volunteers) allows us access to over 100,000 patients within 10-15 miles of our locations.