What are the responsibilities and job description for the Principal Investigator/Physician position at 5PY US Quintiles, Inc.?
Principal Investigator (PI)/Investigator
The statements below reflect the general details considered necessary to describe the major responsibilities of the identified position and are not to be construed as a detailed description of all the work requirements that may be inherent in the job.
POSITION SUMMARY:
The principal investigator or investigator is responsible for the oversight of the study and for adhering to the protocol and Good Clinical Practices.
MAJOR RESPONSIBILITIES:
Essential Functions
1. Knowledge of Good Clinical Practices: The principal investigator must complete the CITI GCP training annually.
2. Investigator Responsibilities:
- The investigator must complete a Form 1572 for the study indicating his agreement to fulfill the responsibilities of an investigator and oversee the investigation personally or through staff with delegated tasks.
- The investigator must provide financial disclosure disclosing any relevant financial interests.
3. Protocol Compliance:
- The investigator oversees the study and ensures the study is conducted in accordance with the protocol.
- The investigator assures that proper informed consent has been obtained for all subjects.
- The investigator delegates responsibilities for the study based on the needs and qualifications required for the study
4. Study drug control: The investigator will discuss and review a plan for product accountability and will assure that controls are in place for approval of drug dispensing.
5. Has read Investigator’s brochure and/or Prescribing Information:
- For Rx-to-OTC or OTC programs: The principal investigator will review the prescribing information and proposed Drug Facts Label for the product.
6. Adverse events: The investigator will assure there are practices in place for subjects to report adverse events during a study.
- The investigator will assure there are guidelines in place for managing expected reactions as well as severe or unexpected reactions. Serious adverse reactions will be reported to the CRO and Sponsor within 24 hours of notification of the adverse event.
- The investigator will guide treatment on any serious adverse events
- The investigator will assign causality to any adverse events.
7. Exams: The principal investigator, or designee sub-investigator will performs pre-study physical examinations (if applicable), review lab data, ECGs and other medical information to ensure volunteers are medically and mentally fit upon entering the study.
8. CRFs/eCRFs: The principal investigator will review and sign CRFs/eCRFs at the conclusion of the study.
POSITION SPECIFICATIONS:
Required
- Appropriate medical license, if necessary for the study.
- Clinical research experience as an investigator or sub-investigator Experience working in a team environment.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Computer skills.
WORKING CONDITIONS
- Regularly required to talk and hear.
- Frequently is required to sit and use hands to finger, handle, or feel.
- Occasionally required to stand, walk, reach with hands and arms, and climb or balance.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
- The noise level in the work environment is usually quiet in an office setting.
- Work is performed with multiple interruptions.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
The potential base pay range for this role, when annualized, is $93,800.00 - $156,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.Salary : $93,800 - $156,300