Principal Investigator (Psychiatry/ Psychiatric)
Tustin, CA, USA
Posted on Thursday, October 12, 2023
Why work at Tilda?
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. Our work leads to faster cures and thus institutes a meaningful impact on millions of lives. You can help us realize that goal.
Who are we?
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.
Who are you?
We are seeking an experienced Principal Investigator (PI) with a Psychiatry/ Psychiatric medicine background to conduct and oversee studies. This role would be at Tilda’s Tustin, CA site. 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.
Duties and Responsibilities:
- 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.
- Ensure the rights, integrity, and confidentiality of all participants in the trial at the site are protected.
- Participate in monitoring visits and sponsor meetings; allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies.
- Perform physical assessments and study procedures.
- Review participants' medical history.
- Administer Investigational Products.
- Review and adhere to the study protocol.
- 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.
- Maintain proper documentation.
- 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.
Required Skills and Abilities:
- Excellent verbal and written communication skills.
- Excellent organizational skills and attention to detail.
- Excellent time management skills with a proven ability to meet deadlines.
- Strong analytical and problem-solving skills.
- Strong supervisory and leadership skills.
- Ability to prioritize tasks and delegate them when appropriate.
- Ability to function well in a high-paced environment.
Education and Experience:
- Medical degree (MD or DO) with board certification in Psychiatry.
- Active medical license in California.
- Clinical research experience is required with a minimum of 10 completed studies.