Principal Investigator

CareAbout•Overland Park, KS

4d•Onsite

About The Position

The Principal Investigator is responsible for the supervision and delegation of the tasks related to the clinical trial they are Principal Investigator of. The Principal Investigator will promote Good Clinical Practices (GCP) during the conduct of clinical investigations by ensuring adherence to protocol requirements, 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 regulation/guidance and standard operating procedure (SOP).

Requirements

MD degree from an accredited Physician Program and Advanced Cardiac Life Support (ACLS) certification required.
Previous experience with similar responsibilities; ideally related to the industry.

Responsibilities

Supervise the clinical activities for the clinical trial they are Principal Investigator.
Delegation of trial related tasks and the review of employees on the Delegation of Authority and Signature Log per job title/training record.
Perform protocol training.
Provide documentation for the Sub-Investigators.
Ensure subject safety at all times, this may include but is not limited to: review of clinical laboratory results and/or other test results. Review and/or performance of vital signs, ECGs or other safety tests.
Perform critical trial related tasks and/or make trial related decisions during the course of the trial.
Ensure subject eligibility is met based on protocol inclusionary/exclusionary criteria and that the subject continues to meet eligibility criteria throughout the course of a clinical trial.
Ensure requirements related to obtaining informed consent are met.
Perform physical examinations and medical history intake and review.
Be on-site for surveillance as required by protocol and remain available on-call for medical events.
Record and follow-up on adverse events and determine causality.
Report serious adverse events to appropriate parties.
Participate in sponsor visits and regulatory audits.
Document study related events incompliance with GCP.
Review study protocols and SOPs.
Complete and/or review regulatory documents as applicable.
Participate in sponsor visits and regulatory audits.
May act as Sub-Investigator on studies not assigned to them as Principal Investigator.