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Part Time PRN Sub Investigator - MD/DO General Medicine

American Clinical Research Services Opco LLC
locationSpringfield, MA, USA
PublishedPublished: 6/14/2022
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Job Description

Job Description

Summary

The Sub-Investigator (Sub-I) plays a vital role in clinical research by supporting the Principal Investigator (PI) in the conduct of clinical trials. This is a part-time, on-site position (approximately 8–10 hours per week) and offers an excellent opportunity for professional growth, with a clear path to advance into a Principal Investigator role.

We are seeking a research-minded physician with a passion for patient-centric care and strong aptitude of learning within clinical research.

Duties and Responsibilities: The Sub-Investigator:

  • Assess study feasibility and ability to deliver on enrollment in consultation with Site Director

  • Attends Site Initiation Visits (SIVs), study feasibility visits, investigator meetings, and required protocol training as applicable.

  • Performs and/or reviews required medical assessments, including physical exams, neurological exams, ECGs, laboratory results, imaging, and drug/toxicology tests.

  • Assesses adverse events for severity, seriousness, and causality in collaboration with the PI.

  • Assists the PI with review and reporting of serious adverse events (SAEs) as needed.

  • Reviews medical history, concomitant medications, and clinically relevant findings as part of eligibility and ongoing safety oversight.

  • Reviews and confirms subject eligibility for study participation.

  • Performs medical and oversight responsibilities delegated by the PI per protocol and regulatory requirements.

  • Provides medical guidance and clinical oversight to the research team as needed.

  • Maintains familiarity with site SOPs and protocol requirements relevant to physician oversight.

  • Supports training and supervision of clinical staff related to medical assessments and protocol conduct.

  • Collaborates with the study team and study monitors regarding subject eligibility, safety, and protocol adherence.

  • Maintains availability to evaluate subjects onsite and/or remotely as required by study visits; scheduling is coordinated in advance.

  • Conducts or oversees the informed consent process when applicable, ensuring subject understanding and use of the current approved ICF following local SOPs

  • Reviews source documentation and signs off on medical assessments and charts as required.

  • Reviews study data and responds to clinical questions or data clarifications related to medical assessments.

  • Ensures subject safety and provides medical judgment regarding continuation, withdrawal, or referral for outside medical care when appropriate.

  • Participates in study-related meetings as needed.

  • Reviews and maintains familiarity with the Investigator’s Brochure (IB), including known risks and safety information.

  • Occasional travel to investigator meetings or company-sponsored meetings, as applicable.

  • Performs other physician-level duties related to study oversight as assigned by the PI or medical leadership.


Competency Requirements:

  • Strong clinical judgment and decision-making skills

  • Clear and effective communication with clinical staff and monitors

  • Ability to work collaboratively within a multidisciplinary research team

  • Attention to subject safety, protocol compliance, and data integrity

  • Adaptability in a fast-paced research environment


Physical Requirements and Environmental Factors:

  • Mid-level computer use
  • Patient-facing interaction and record/result trend review and tracking

  • Work is normally performed in a typical interior clinical/office environment.

  • Prolonged periods of sitting at a desk and working on a computer.
  • Lifting of 20 pounds and occasionally more than 20 pounds.



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