Principal Investigator

CareAbout; Overland Park (KS); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Health/Dental/Vision Insurance Plans

401(k)/RRSP with Employer Match

Paid Vacation and Holidays

Paid Sick and Bereavement Leave

Employee Assistance & Telehealth

Training & Development Programs

Employee Referral Bonus Program

Job summary

Altasciences in Overland Park, KS invites a Principal Investigator to supervise clinical trial activities, ensure GCP compliance, protect participant welfare, and direct investigations per protocol and SOP. The role requires an MD with ACLS and prior PI experience, with on-site presence and collaboration with sponsor visits and audits.

Join a team offering comprehensive benefits and opportunities for professional development. On-site role with strong teamwork in a regulated environment.

Qualifications

• MD degree from an accredited Physician Program is required.
• ACLS certification is required.

Responsibilities

• Supervise the clinical activities for the clinical trial they are Principal Investigator.
• Delegate trial tasks and review delegation logs per title/training.
• Perform protocol trainings and provide documentation for Sub-Investigators.
• Ensure subject safety, review safety data, vital signs, ECGs, and other safety tests.
• Make trial-related decisions during the course of the trial.
• Confirm subject eligibility per protocol and monitor ongoing eligibility.
• Obtain informed consent and conduct history intake and physical exams.
• Be on-site for surveillance and remain available on-call for medical events.
• Record, report, and determine causality for adverse events.
• Participate in sponsor visits and regulatory audits.
• Review study protocols and SOPs; complete regulatory documents as applicable.
• May act as Sub-Investigator on studies not assigned to them.

Education

MD degree

ACLS certification

Job description

About The Role

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).

You’ll Do Here

• 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.

What You’ll Need to Succeed

• 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.

What We Offer

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences’ Benefits Package Includes:

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs

Altasciences’ Incentive Programs Include:

• Training & Development Programs
• Employee Referral Bonus Program