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Principal Investigator

3 months ago

Milwaukee, United States Medix Full time

Medix is currently hiring for a Principal Investigator in Milwaukee, WI area to join a clinical research organization on a part-time or full-time basis. Previous research experience is not required. An active license to practice medicine in Wisconsin as well as Board Certification is required.

Job Summary:

To conduct clinical research studies overseeing all aspects of the study(ies) and supervising the clinical trial(s) in accordance with 21 CFR part 312, Site SOPS, study protocols and other applicable regulations

Responsibilities:

  • Performs all job responsibilities in accordance with standards of Good Clinical Practice (GCP), clinic SOPs, OSHA guidelines, Federal and local regulations
  • Signs the 1572 and abides by commitments as contained in the 1572 and 21 CFR Part 312.
  • Completes all required training programs per company requirements
  • Honors password protections
  • Reports to Director of Medical Strategy and Oversight on all administrative, logistical and staff related site issues
  • Ensures study participants confidentiality and HIPAA compliance
  • Attends in Site Initiation Visits, safety meetings and dose escalation meetings as required
  • Reads and has knowledge of study protocols and Investigators Brochure
  • Timely evaluation/sign-off of study documentation
  • Perform competencies as trained and as applicable to study protocols
  • Oversees overall clinical study functions including eligibility criteria, study participants safety and data integrity
  • Completes necessary regulatory documents in a timely manner
  • Ensures that studies are conducted according to protocol, SOPs, and regulatory requirements
  • Ensures that all staff assisting in the conduct of study is informed of their obligations in meeting regulatory commitments
  • Ensures that all staff are trained and delegated in study related tasks

Minimum Qualifications: MD or DO degree, an active physician license (in good standing) in the state of practice for this role. Board certification in area of specialty preferred. CPR required / ACLS preferred.

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