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26 days old

Clinical Trial Principal Investigator – Collaborating Physician

CVS Health
Texas Work Remotely
  • Job Type
    Employee
  • Job Status
    Full Time

CVS® Clinical Trial Services™ is seeking quality physicians to become virtual research investigators for select MinuteClinics® and HealthHUBs™.

CVS® Clinical Trial Services™ is working to advance health care by making clinical research more accessible to all communities that we serve. Our “human-centric” approach is designed to improve the patients’ experience, foster health equity, and enhance research effectiveness. Through our robust data and ability to leverage our in-clinic, in-home and virtual capabilities, we can deliver studies in ways that are better for the patient and study protocols. We are seeking quality physicians, like you, to become virtual research investigators for select MinuteClinics® and HealthHUBs™, for states in which you are licensed.

Last May, we launched our model and have enrolled over 15,000 patients in studies across many therapeutic areas to date. With much opportunity and development ahead, we are seeking to collaborate with local providers to extend our geographic footprint and our presence within the community.

Core Responsibilities of the Principal Investigator:

Accountable for the successful completion of the study.

• Personally conduct or supervise investigation

• Follow protocol- ensuring inclusion and exclusion criteria are met, only make changes after notifying the sponsor unless subject at risk

• Ensure all persons assisting with the study are informed of obligations

• Inform subjects that drugs are being used for investigational purposes

• Ensure informed consent (21 CFR Part 50) and IRB review, approval, and reporting (21 CFR Part 56)

• Report to sponsor adverse events (21 CFR 312.64); read and understand the IB

• Maintain adequate and accurate records (21 CFR 312.62) and make them available for inspection in accordance with 21 CFR 312.68

• Ensure initial and continuing review by an IRB and report all changes to research and unanticipated problems involving risks to subjects, not make any changes without IRB approval except where necessary to eliminate immediate hazards

• Comply with other requirements in 21 CFR

 

Requirements

Eligibility Requirements:

Sponsors or networks are required to select only “investigators qualified by training and experience as appropriate experts to investigate the drug” (21 CFR 312.53(a)). An MD is not necessary.

If clinical investigator “is a non-physician, a qualified physician (or dentist when appropriate) should be listed as a sub investigator, responsible for all trial-related medical (or dental divisions).

Other Requirements:

PI must understand:

a) Adherence to Code of Federal Regulations

b) Knowledge of Clinical Investigator regulations

c) Understanding of Clinical Investigator responsibilities

No investigator may participate in an investigation until they provide the sponsor with a completed, signed Statement of Investigator, Form FDA 1572 [21 CFR 312.53(c)]

Categories

Posted: 2022-09-06 Expires: 2022-10-06

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Clinical Trial Principal Investigator – Collaborating Physician

CVS Health
Texas

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