Principal Investigator Job at Barrington James, Saint Louis, MO

MVk4MG52TE1UM1ZoWEhBU2ZPRERqd0cz
  • Barrington James
  • Saint Louis, MO

Job Description

Job Responsibilities:

  • Provide overarching medical direction and review of study protocols in alignment with the investigational plan and Good Clinical Practice (GCP).
  • Offer medical expertise and assess scientific feasibility for new sponsor inquiries.
  • Safeguard the safety, rights, and well-being of all study participants at the trial site.
  • Ensure the integrity, accuracy, and credibility of clinical data collected at the site.
  • Protect the confidentiality and personal integrity of participants throughout the study.
  • Collaborate with and support clinical operations, research teams, and sponsor representatives as needed.
  • Review and/or obtain participants’ medical histories in accordance with study requirements.
  • Conduct physical examinations, assessments, and study-related procedures per protocol.
  • Evaluate and interpret clinical findings, including diagnostic tests such as ECGs, lab results, and imaging.
  • Promptly report Serious Adverse Events (SAEs) and any participant safety concerns to the sponsor and IRB as per protocol-specific guidelines.
  • Oversee the administration and accountability of the Investigational Product (IP).
  • Review, understand, and comply with the study protocol and all regulatory requirements.
  • Maintain comprehensive, accurate, and timely documentation consistent with source data.
  • Ensure IRB approval of all study-related documents (protocol, consent forms, recruitment materials) prior to study initiation and throughout its duration.
  • Provide the IRB with essential product information, including the Investigator’s Brochure or Product Monograph, to support risk assessment.
  • Notify the IRB of protocol amendments, safety updates, deviations, and unanticipated issues during the study.
  • Remain fully informed on the proper use and safety profile of the investigational product as described in sponsor-provided materials.
  • Adhere to all applicable regulatory requirements and ICH-GCP standards.
  • Maintain and archive essential study documents in accordance with regulatory guidelines, including retention for at least two years post-study conclusion or product discontinuation.
  • Participate in monitoring visits, sponsor meetings, and regulatory inspections, and grant access to all relevant study records.
  • Ensure participants receive appropriate care and follow-up in the event of premature study termination or suspension.
  • Provide detailed written communication to the IRB and sponsor in the event of study termination or suspension initiated by the investigator.

Job Requirements:

  • Must have previous research experience.
  • Onsite - part time position in St. Louis, MO
  • Principal Investigator will be reporting to site Director at the location
  • Exceptional written and verbal communication skills for report writing and presenting findings.
  • Proven ability to lead a team and manage priorities in a fast-paced setting.
  • Keen attention to detail and a strong commitment to maintaining confidentiality with sensitive information.

License/Certification:

  • Minimum qualifications include an M.D or D.O with an active medical license
  • Board certification in Family Medicine, Internal Medicine or Primary Care (Prefer Board certification or board eligibility in Dermatology)
  • Medical licensure in Missouri

Job Tags

Similar Jobs

Bluebird Staffing

Medical Biller onsite in Louisiana Job at Bluebird Staffing

 ...Bluebird has a contract position for Medical Biller position in Madisonville, LA $20/hr...  ...process past due payments/claims Required Remote Medical Biller: Must have CPR+ Must...  ...claim experience Must have medical billing experience Must have PBM experience... 

24 Seven Talent

Accessories Designer - Modern Bags & Lifestyle Accessories Job at 24 Seven Talent

 ...in a fast-paced environment while maintaining attention to detail and brand standards Qualifications: Bachelors degree in Fashion Design or related field preferred Proven experience designing accessoriesbags, packs, or similar productswith a strong portfolio... 

Safro Staffing

Hospice Clinical Director Job at Safro Staffing

 ...Safro Staffing is recruiting for a hospice client in Novi, MI seeking an Interim Clinical Director, with the potential to transition into a full-time role. Qualifications: ~ Active RN license in Michigan ~ Bachelors in Nursing (Masters preferred)~5+ years of... 

Michilli Inc.

Construction Scheduler (Part Time or Contract) Job at Michilli Inc.

Overview : The Construction Scheduler is responsible for developing, maintaining, and analyzing detailed project schedules to support successful and timely project execution. Working closely with project managers, superintendents, and subcontractors, the Scheduler plays...

AJ Tutoring

SAT tutor Job at AJ Tutoring

Test Prep Tutors Wanted! Beautiful Office, Great Training! $35/hr +. Join the most professional 1-on-1 tutoring team in the Bay Area. If you're bright, energetic, and eager to meet students in person, wed love to talk with you! Ideal test prep tutors are: Passionate...