Physician- Principal Investigator (Oceanside, CA)

The Company Profound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and patients get access to the newest therapies available. Mission, Vision, Values o   Mission: Ensure that every patient has access to innovative treatments and improve patient lives.o   Vision: The future of medical innovation rests in the hands of physicians and their everyday care delivery decisions.o   Values: o   Compassion: Honor the patient-physician relationship above all else. o   Efficiency: Accountable for outcomes and strive for process perfection. o   Progress: Contribute to continued innovation in medicine while improving health outcomes. o   Integrity: Hold ourselves to the highest ethical, quality, and scientific standards in every activity
Profound Ethos •         Physicians are the Vanguard •         All Decisions Improve Patient Care •         Never Compromise Quality 
Role: (PI) Principal InvestigatorCompany: Profound ResearchLocation: Oceanside, CA
Why this Role ExistsPromote good clinical practices while conducting clinical investigations according to ICH/FDA/GCP guidelines, local regulations, and company policies and procedures. The Principal Investigator will assure adherence to protocol requirements, protecting the rights and welfare of clinical trial participants, and assure data integrity while directing the conduct of the clinical trial. Responsibilities-Provide medical and clinical expertise into the conduct of clinical trials-Provide leadership and oversight of clinical research staff focusing on patient safety and compliance to study protocols and all regulatory requirements-Evaluate and assesses clinical trial participants to ensure their for enrollment into the clinical trials-Ensure the clinical trial participants are treated respectfully and have a positive experience during their every phase of their clinical trial participation-Interacts positively and collaboratively with sponsors, clients and team members-Helps to provide supplemental protocol training for staff to ensure a thorough understanding-Participate in Investigator Meetings (IMs), and continuing education activities in order to maintain current medical and clinical trial knowledge-Perform other duties as assigned, requested, or required based on the needs of the participants, protocols and/or company
Essential Duties -Maintain a current curriculum-Maintain current licensure to-Provide the sponsor and institutional review board (IRB) with documentation of credentials as-Demonstrate the proper education, training and experience to conduct the clinical-Assume responsibility for the conduct of the clinical-Sign the form FDA 1572 as-Sign the protocol as-Sign sponsor contract(s) as-Document the financial aspects of the-Disclose conflicts of interest as described in the-Possess a thorough understanding of the requirements of each-Determine that inclusion/exclusion criteria are applicable to the study-Assure recruitment goals are reasonable and-Assess overall protocol-Follow the trial's randomization-Not implementing any protocol deviation or changes without agreement by the sponsor and prior review and approval by the IRB (except to eliminate immediate hazards to the subject).-Review the inclusion/exclusion criteria, schedule of visits, end point criteria and investigational article use with the research team.-Providing the IRB with adequate information to initially review the study (i.e., protocol, investigator's brochure, informed consent form, recruitment advertisements and any written information to be given to subject(s).-Providing the IRB with documents for ongoing review (i.e., amendments to the protocol, adverse events, deviations or new information).-Explaining any discrepancies between source documents and case report-Endorsing changes or corrections to a case report-Documenting deviations from the approved-Documenting and explaining premature unblinding of the investigational product(s).-Documenting that informed consent has been obtained from the subject or legal-Ascertaining the reason for a patient's premature study-Documenting adverse-Complying with written procedures to document changes to data and/or case report-Providing study reports as requested by the sponsor, IRB and regulatory authority(ies).-Being thoroughly familiar wit