Principal Investigator

Found in: Jooble US O C2 - 2 weeks ago

Tustin CA, United States Tilda Research Inc. Full time

Tilda exists to accelerate the development of new medical treatments by providing every person easy access to clinical trials. As a tech-enabled clinical trial network, we build software and services to help pharma innovators better execute their clinical trial programs. You can help us realize that goal.
Tilda Research is an innovator in clinical research recruitment and trial execution. We operate a growing network of clinical research sites in the US, and our team has worked on over 250 pan-indication Phase I through IV studies. Our founders are successful serial entrepreneurs, with three of their past companies leading to IPOs (VMware, MobileIron) or exits (LexentBio acquired by Roche). We also build software and support clinical trial infrastructure to help pharmaceutical companies identify, enroll, and execute clinical trials efficiently.
We are seeking an experienced Principal Investigator (PI) with a Rheumatologist / Rheumatology medical background to conduct and oversee studies. You will be responsible for ensuring the successful execution of research protocols, patient safety, maintaining compliance with regulatory requirements, and contributing to the growth and success of our research site. This is a partnership opportunity to conduct clinical research with Tilda Research where Tilda will provide Investigators with facilities, staff, systems, and business development.
Provide overall medical direction and medical review of protocols in conformance with the investigational plan and good clinical practice.
Provide medical and scientific feasibility assessments for all new sponsor inquiries.
Ensure that the safety and well-being of all participants in the study at the trial site are protected.
Ensure data collected at the study site is credible and accurate.
Participate in monitoring visits and sponsor meetings; allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies.
Review participants' medical history.
Be thoroughly familiar with the appropriate use of the investigational product (study drug) as described in the protocol and Investigator's brochure/product monograph and other documents provided by the sponsor.
Ensure accuracy, completeness, legibility, and timeliness of data reported on the CRF (case report form) and be consistent with source documents.
Ensure participants are informed and receive appropriate therapy and follow-up if the trial is prematurely terminated or suspended for any reason.
Immediately report Serious Adverse Events (SAEs) or any abnormalities affecting participants' safety to sponsors and the IRB as per specific reporting guidelines.
Ensure that the study, consent, and other documents provided to the subjects are approved by the IRB and comply with GCP and other regulatory requirements.
Maintain trial documents specified by the Essential Documents section of the ICH guidelines and as required by applicable regulatory requirements.
Provide access to research-related records to monitors, auditors, representatives of the IRB, and regulatory authorities.
Medical degree (MD or DO) with board certification in Internal Medicine or Family Medicine.
Active medical license in California.
Clinical research experience is required with a minimum of 10 completed studies.
$

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