Physician Principal Investigator (MD or DO)
- Pay Rate: $200K – $250K USD Yearly
- Location: Waterbury, CT
Raise is currently hiring a permanent, full-time team member on behalf of our client. They’re expanding their team to meet growing needs, making this a unique opportunity to work with an industry leader.
Responsibilities
Job Description
Option 1: 5 Days per Week (generally M-F) with occasional overnight travel. Days each week can vary dependent on travel requirements.
Option 2: 4 Days per Week (M-F) with occasional overnight travel. Days each week can vary depending on travel requirements.
Option 3: 20 hours or less per week (M-F daytime) with occasional overnight travel.
Locations: Waterbury, CT (primary) Hamden, CT
General Summary of Duties: The Principal investigator/Sub investigator (PI)will be responsible for overseeing a number of sponsor initiated clinical research trials at both of CMR’s sites in Connecticut. As such, the physician is responsible for promoting good clinical practice in the conduct of clinical investigations. Ensure adherence to protocol requirement, protecting the rights and welfare of subjects, assuring the integrity of data generated at the site and directing the conduct of the clinical investigation according to federal and state regulations and guidance documents.
In a typical workday, the principal investigator will be utilized to evaluate potential participants’ eligibility for clinical trial. This will include consultation with the patient recruitment specialists when evaluating a potential subject for inclusion in a study. This will also happen during the initial screening of the subject and will include consultation with the study coordinators.
Within the CMR SOP guidelines, the PI will review and sign-off on subject visits to ensure that all the documentation for a trial has been recorded properly and accurately. PI will also assess and report any potential adverse events that could have been caused by the investigational product being studied.
The PI may be given quality assurance initiatives and work with specific staff on improving clinical processes.
The PI will represent the company at different community outreach activities, including relevant clinical presentations. This will also include clinical related blogs and online videos for website and social media.
The PI will also assist in the evaluation of study feasibilities and work with the business development staff in this area.
The individual will be dealing with clinical and administrative professionals internally and externally, as well as subjects and potential subjects.
Supervision Received: Medical Director
Supervision Exercised: Direct-Specifically Related to Studies As PI:
• Director of Clinical Operations
• Clinical Research Coordinators
• Assistant Clinical Research Coordinators
Indirect-Specifically Related to Studies As PI:
• Patient Recruitment Specialists
Typical Physical Demands: Frequent mobility and/or sitting required for extended periods of time. Some bending and stooping required. Requires occasional lifting of up to 45 pounds of boxes or paper. Requires manual dexterity to operate keyboard, fax/copy machine and other office equipment. Requires eyesight correctable to 20/20 to read.protocols, source documents and computer terminals. Requires hearing within normal range for telephone use.
Typical Working Conditions: Work is performed in both clinical settings and office environments and requires desk, computer and counter work. Frequent contact with pharmaceutical sponsors. Possible exposure to blood products and infectious disease, blood borne pathogens, body fluids, accidental needle sticks, difficult to manage patients, hazardous materials, and powdered-latex gloves. There is occasional travel and driving of own vehicle.
RESPONSIBILITIES: This list may not include all of the duties assigned.
1. Works with the following:
a. Chief Executive Officer
b. Medical Director
c. Other Principal Investigators, Sub-Investigators & Physicians
d. Director of Clinical Operations
e. Director of Business Development
f. Chief Financial Officer
g. Clinical Research Coordinators
h. Patient Recruitment Specialists
i. Monitors, CRAs, and Sponsor/CRO representatives
j. Clinical Research Team Members
k. Study Subjects and Potential Study Subjects
2. Maintains investigator qualifications and agreements by
a. Maintaining a current and up-to-date resume
b. Maintaining current licensure to practice
c. Provides the sponsor and IRB with documentation of credentials as requested.
d. Demonstrating the proper education, training, and experience to conduct the clinical trial investigation.
e. Assume responsibility for the conduct of the clinical trial investigation.
f. Completing required study trial training Signing the following:
i. Form FDA 1572
ii. Protocol
iii. Sponsor contracts, as necessary
iv. CDAs
g. Disclosing conflicts of interests as described in the regulations.
3. Ensures protocol compliance.
4. Ensures initial and ongoing review by a duly constituted IRB.
5. Determines adequate resources are available to conduct the clinical trial.
a. Ensuring he/she has adequate time to conduct and supervise the clinical trial.
b. Ensuring there is adequate qualified staff to conduct the clinical trial.
c. Oversee study start-up training of staff
6. Manage the medical care of subjects.
a. Ensuring that a qualified physician is responsible for all trial related medical decisions.
b. 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.
c. Assessing the subject’s compliance with the investigative medication/device and follow-up visits.
d. Assessing the subject’s response to therapy.
e. Evaluating adverse events and ensuring the medical care is provided to a subject for any adverse event.
f. Informing a subject when medical care is needed to treat a current illnesses.
g. Informing the subject’s primary physician about the participation in the trial.
h. Review’s safety reports relevant to study drug.
7. Protects the Rights and Welfare of Subjects
a. Reporting all serious adverse events immediately to the sponsor and IRB.
b. Obtaining a signed and dated informed consent from the subject or subject’s legal representative prior to initiating any study-related procedures.
c. Informing the subject or legal representative abut all aspects of the clinical trial.
d. Providing new information about the study.
8. Ensuring Validity of the Data Reported to the Sponsor
a. Ensuring the accuracy, completeness, legibility and timeliness of the case report forms.
b. Ensuring the case report forms accurately reflect source documents.
c. Endorsing changes or corrections to a case report form.
9. Ensures Documentation of Study Related Procedures, Processes and Events
a. Maintaining trial documents as required by the regulations and sponsor for the appropriate timeframe and under secure conditions.
b. Providing study reports as requested by the sponsor, IRB and regulatory authorities.
10. Ensures the Proper Use and Storage of Investigational Agents
a. Assuming responsibility for the investigational product at the trial site.
b. Ensuring the proper use and storage of the investigational product at the trial site.
c. Assigning responsibility to the appropriate research pharmacy personnel.
11. Directs Site Clinical Operations for Assigned Clinical Trials
a. Meeting regularly with the research team to discuss subject participation and protocol progress.
b. Ensuring that all research staff are informed about the protocol and investigational agents.
c. Participating in monitoring visits and audits as appropriate.
d. Delegating authority at the site appropriately.
e. Maintaining a list of qualified persons and their corresponding trial-related delegated duties.
12. Evaluation of Study Participation and Selection
a. Participate in development of the study participation strategies as requested.
b. Review identified protocols for applicability to site’s capabilities and decide on accepting or declining the clinical trial.
c. Assist in study questionnaires as requested.
d. Meet with CRAs/Monitors during Pre-Study Visits.
e. Occasional chart review as requested.
13. Brand Presence and Reputation
a. Individual will work diligently to develop their reputation in clinical research.
i. Meetings with key individuals in pharmaceutical industry.
ii. Written digital blogs on relevant medical topics for both potential subjects to read as well as other blog topics for industry awareness.
iii. Maintain a presence on Linked In or other relevant industry social platforms.
iv. Video webinars on relevant therapeutic areas for viewing by potential patients/subjects.
v. Community presentations.
14. Employee will update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; and participating in professional organizations to facilitate knowledge in the pharmaceutical industry and investigator trial site field.
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.
15. Occasional overnight travel, e.g. attendance at investigator meetings.
PERFORMANCE REQUIREMENTS:
Knowledge, Skills, and Abilities:
Medical Degree and Board Certification. Understanding the Customer (Sponsors, CROs), Understanding the Pharmaceutical
Investigational New Drugs (“IND”) Industry, Product Development, and Client Relationships. In-depth knowledge of research regulations and standards. Proficient in common research software used by sponsors/CROs to communicate with sites. In addition, competency in basic business software, including MS Word, MS Excel and Outlook.
Skills/Qualifications:
For medical qualifications see education requirements below and Responsibility Section 2.
Strongly prefer an individual with extensive experience in sponsor initiated clinical research trials, e.g. >30 clinical trials as a Principal Investigator in pharmaceutical industry.
Skill in establishing and maintaining effective working relationships with other employees, pharmaceutical organizations, and the public.
Must be highly proficient in utilizing medical software, including eSource and Clinical Trial Management Software, and EHRs.
Education:
Medical Degree from a licensed and appropriately accredited medical school, Residency, Internship, and Fellowship as necessary for the applicable medical specialty.
Strongly prefer Board Certification in Medical Specialty Area(s): Internal Medicine and/or Endocrinology
Experience:
Strongly prefer experience in clinical research environment and at least five (5) years of medical practice experience.
Alternative to Minimum Qualifications: None.
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