Principal Investigator Job at Barrington James, Saint Louis, MO

ZHZzNjRRRElGMU91NE0yVmNoU2krL1hlTGc9PQ==
  • 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

Part time,

Similar Jobs

Baldor Specialty Foods, Inc.

Truck Driver Job at Baldor Specialty Foods, Inc.

 ...Box Truck Driver (CDL Not Required) Pay: $20 per hour + weekly performance incentives (averaging $24 per hour)...  ...Drivers will be responsible for: Day to day deliveries based on assigned routes. Following customer service delivery standards and meeting... 

HKP

Data Entry Clerk Job at HKP

 ...Accuracy in data entry Dependability Job Type: Full-time Job Type: Full-time Pay: $55.00 per hour Benefits...  ...insurance Paid time off Vision insurance Schedule: Evening shift Monday to Friday Experience: Data entry: 1... 

Best Impressions Caterers

Sous Chef Job at Best Impressions Caterers

 ...Sous Chef Best Impressions Catering (Charlotte, NC) Best Impressions Catering is looking for a talented and experienced Sous Chef to join our team in Charlotte, NC. This role is ideal for a skilled culinary professional who thrives in a fast-paced catering environment... 

Honeybee Hires

Pediatric Occupational Therapist (OT) Job at Honeybee Hires

 ...Occupational Therapist (OTR/L) Pediatric Clinic in Lakewood, WA $5,000 Sign-On Bonus + Relocation Assistance Make an impact in the lives of childrenboth locally and globally. Join a clinician-owned private practice that blends high-quality pediatric therapy with... 

LION Charter School

High School English Teacher Job at LION Charter School

 ...students develop their character and the skills they need for life through rigorous academics, self-discovery, and family involvement Teachers at LION Charter School: Believe the purpose of education is both academic achievement AND character development Provide...