Physician Sub-Investigator Consultant

ClinChoice

5d•Onsite

About The Position

ClinChoice is searching for Physician Sub-Investigator Consultant 12 months Contract with possibility of extension to join one of our consumer product clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Requirements

ABIM board certified (and verified) in internal medicine (and may be subspecialized as well).
Experience in clinical medicine which may include hospital-based or clinic-based practices, for at least one year after their terminal training.
Clean DEA registration and unrestricted license to practice medicine in Florida.
MD with board certification in internal medicine, active FL medical license, unrestricted license

Responsibilities

The duties may include screening procedures such as routine physical examinations of healthy volunteers, ECG interpretation, review of labs, eligibility assessment for prospective study participants, management of adverse events, on-site supervision of investigational product dosing, and related duties.
Delegates study responsibilities as appropriate to trained study staff
Possesses a working knowledge of GCP/ICH guidelines, Clinic SOPs, QA/QC procedures, and Investigator 1572 Form
Reviews Investigator’s Brochure prior to performing any study procedures
Performs all study responsibilities in compliance with the IRB approved protocol
Reviews screening documentation and approves subject for admission to study
Reviews admission documentation and approves subject for randomization
Interprets ECGs within agreed Sponsor timeline
Documents all findings in subject specific source documents
Provides ongoing assessment of the study subject/patient to identify Adverse Events
Ensures proper documentation and reporting of all Adverse Events and Serious Adverse Events
Reviews and evaluates all study data and comments to the clinical significance of any out-of-range results
Performs physical examinations as part of screening evaluation and active study conduct
Provides medical management of adverse events as appropriate
Completes all study documentation in accordance with the study specific requirements
Communicated with Sponsors and auditors as requested
Participates in on-call activities as required to ensure adequate medical coverage
Monitors safety and well-being of study participants at all times
Provides coverage for the Clinic Principal Investigator
They should be able to work and thrive in a team-based environment.