Profound Research
Physician- Principal Investigator (Pasadena, CA)*
Profound Research, Pasadena, California, United States, 91122
The CompanyProfound 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, ValuesMission:
Ensure that every patient has access to innovative treatments and improve patient lives.Vision:
The future of medical innovation rests in the hands of physicians and their everyday care delivery decisions.Values:Compassion:
Honor the patient-physician relationship above all else.Efficiency:
Accountable for outcomes and strive for process perfection.Progress:
Contribute to continued innovation in medicine while improving health outcomes.Integrity:
Hold ourselves to the highest ethical, quality, and scientific standards in every activity.Profound EthosPhysicians are the VanguardAll Decisions Improve Patient CareNever Compromise QualityRole: (PI) Principal InvestigatorCompany: Profound ResearchLocation: Pasadena, CAWhy 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.ResponsibilitiesProvide 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 assess clinical trial participants to ensure their enrollment into the clinical trials.Ensure the clinical trial participants are treated respectfully and have a positive experience during every phase of their clinical trial participation.Interact positively and collaboratively with sponsors, clients, and team members.Help 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 DutiesMaintain a current curriculum.Maintain current licensure.Provide the sponsor and institutional review board (IRB) with documentation of credentials.Demonstrate the proper education, training, and experience to conduct the clinical trial.Assume responsibility for the conduct of the clinical trial.Sign the form FDA 1572.Sign the protocol.Sign sponsor contract(s).Document the financial aspects of the trial.Disclose conflicts of interest.Possess a thorough understanding of the requirements of each protocol.Determine that inclusion/exclusion criteria are applicable to the study.Assure recruitment goals are reasonable.Assess overall protocol adherence.Follow the trial's randomization.Not implement any protocol deviations 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.Provide the IRB with adequate information to initially review the study.Provide the IRB with documents for ongoing review.Explain any discrepancies between source documents and case report forms.Endorse changes or corrections to a case report.Document deviations from the approved protocol.Document and explain premature unblinding of the investigational product(s).Document that informed consent has been obtained from the subject or legal representative.Ascertain the reason for a patient's premature study withdrawal.Document adverse events.Comply with written procedures to document changes to data and/or case report forms.Provide study reports as requested by the sponsor, IRB, and regulatory authorities.Be thoroughly familiar with the use of the investigational product(s).Read the current investigator's brochure, product insert, or other source documents.Assume responsibility for the investigational product at the trial site.Ensure the proper use and storage of the investigational product(s) at the trial.Review the proper use of the study article(s) by the subjects.Communicate effectively with subjects, research team, IRB, and sponsors.Meet regularly with the research team to discuss subject participation and protocol adherence.Assure that all research staff are informed about the protocol and investigational product(s).Be knowledgeable about regulatory requirements and GCP.Prepare for and attend investigator and start-up meetings.Participate in monitoring visits and audits as required.Permit monitoring and auditing by the sponsor and appropriate regulatory authorities.Make available to monitors, auditors, IRB, and regulatory authorities all requested trial-related records.Delegate authority at the site.Assure that all research staff are informed about their trial-related duties and responsibilities.Maintain a list of qualified persons and their corresponding trial-related delegated duties.Retain overall responsibility for the trial.Document every study-related action to show that the study complies with all guidelines and is a credible trial.Ensure data quality by confirming that data is diligently collected, recorded, and amended.Secure written IRB approval before initiating the study or instituting any changes to the protocol as approved.Provide written summaries of the trial status to the IRB annually, or as required.Provide written information of premature termination or suspension of a study.Provide the IRB with all documents subject to their review.Determine adequate resources are available to conduct the study by assuring he/she has adequate time to conduct and supervise the study.Assure that a qualified physician (PI or sub-investigator) is responsible for all trial-related medical decisions.Assess subject compliance with the test article and follow-up.Assess subject's response to treatment.Evaluate for adverse events.Ensure that medical care is provided to a subject for any adverse event(s).Inform a subject when medical care is needed to treat an intercurrent illness(es).Inform the subject's primary physician about their participation in the study.Report all serious adverse events immediately to the sponsor and IRB.Assure that the informed consent form contains all the elements required by CFR 56.Obtain a signed and dated informed consent from the subject or subject's legal representative before initiating any study-related procedures.Inform the subject or legal representative about all aspects of the clinical trial.Provide new information about the study or test article(s).Ensure subject understanding.Provide the subject or subject's legal representative with a copy of the signed and dated informed consent form.Assure that the informed consent form is in language that is understandable to the subject.Secure a witness to the informed consent process when the subject or legal representative is unable to read.Allow ample time and opportunity for the consent process and answering questions about the trial to the satisfaction of the subject or legal representative.Secure consent/assent from minors and mentally impaired subjects as required.Follow emergency use guidelines for waiver of consent in emergency situations as directed by the federal regulations and IRB policy and procedures.Ensure the accuracy, completeness, legibility, and timeliness of case report forms.Ensure that case report forms accurately reflect source documents.Ensure adequate information in source documents.Record all safety data in medical records and report SAEs immediately to the sponsor.RequirementsMedical Licensed in CA.Trained and experienced in clinical research.Familiar with the background of the study drug and requirements of the study.Have high ethical standards and professional integrity.Friendly and outgoing.Must demonstrate a passion for direct patient care.Demonstrate clinical competence, positive leadership, and ability to work collaboratively with a multidisciplinary team.Regular and punctual attendance.Perform other duties as assigned.Embrace Profound’s core values.Travel RequirementsOccasional travel up to 20%.Physical RequirementsProlonged periods of sitting at a desk and working on a computer, standing and walking.Must be able to lift 25 pounds at times.Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound.The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
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Ensure that every patient has access to innovative treatments and improve patient lives.Vision:
The future of medical innovation rests in the hands of physicians and their everyday care delivery decisions.Values:Compassion:
Honor the patient-physician relationship above all else.Efficiency:
Accountable for outcomes and strive for process perfection.Progress:
Contribute to continued innovation in medicine while improving health outcomes.Integrity:
Hold ourselves to the highest ethical, quality, and scientific standards in every activity.Profound EthosPhysicians are the VanguardAll Decisions Improve Patient CareNever Compromise QualityRole: (PI) Principal InvestigatorCompany: Profound ResearchLocation: Pasadena, CAWhy 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.ResponsibilitiesProvide 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 assess clinical trial participants to ensure their enrollment into the clinical trials.Ensure the clinical trial participants are treated respectfully and have a positive experience during every phase of their clinical trial participation.Interact positively and collaboratively with sponsors, clients, and team members.Help 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 DutiesMaintain a current curriculum.Maintain current licensure.Provide the sponsor and institutional review board (IRB) with documentation of credentials.Demonstrate the proper education, training, and experience to conduct the clinical trial.Assume responsibility for the conduct of the clinical trial.Sign the form FDA 1572.Sign the protocol.Sign sponsor contract(s).Document the financial aspects of the trial.Disclose conflicts of interest.Possess a thorough understanding of the requirements of each protocol.Determine that inclusion/exclusion criteria are applicable to the study.Assure recruitment goals are reasonable.Assess overall protocol adherence.Follow the trial's randomization.Not implement any protocol deviations 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.Provide the IRB with adequate information to initially review the study.Provide the IRB with documents for ongoing review.Explain any discrepancies between source documents and case report forms.Endorse changes or corrections to a case report.Document deviations from the approved protocol.Document and explain premature unblinding of the investigational product(s).Document that informed consent has been obtained from the subject or legal representative.Ascertain the reason for a patient's premature study withdrawal.Document adverse events.Comply with written procedures to document changes to data and/or case report forms.Provide study reports as requested by the sponsor, IRB, and regulatory authorities.Be thoroughly familiar with the use of the investigational product(s).Read the current investigator's brochure, product insert, or other source documents.Assume responsibility for the investigational product at the trial site.Ensure the proper use and storage of the investigational product(s) at the trial.Review the proper use of the study article(s) by the subjects.Communicate effectively with subjects, research team, IRB, and sponsors.Meet regularly with the research team to discuss subject participation and protocol adherence.Assure that all research staff are informed about the protocol and investigational product(s).Be knowledgeable about regulatory requirements and GCP.Prepare for and attend investigator and start-up meetings.Participate in monitoring visits and audits as required.Permit monitoring and auditing by the sponsor and appropriate regulatory authorities.Make available to monitors, auditors, IRB, and regulatory authorities all requested trial-related records.Delegate authority at the site.Assure that all research staff are informed about their trial-related duties and responsibilities.Maintain a list of qualified persons and their corresponding trial-related delegated duties.Retain overall responsibility for the trial.Document every study-related action to show that the study complies with all guidelines and is a credible trial.Ensure data quality by confirming that data is diligently collected, recorded, and amended.Secure written IRB approval before initiating the study or instituting any changes to the protocol as approved.Provide written summaries of the trial status to the IRB annually, or as required.Provide written information of premature termination or suspension of a study.Provide the IRB with all documents subject to their review.Determine adequate resources are available to conduct the study by assuring he/she has adequate time to conduct and supervise the study.Assure that a qualified physician (PI or sub-investigator) is responsible for all trial-related medical decisions.Assess subject compliance with the test article and follow-up.Assess subject's response to treatment.Evaluate for adverse events.Ensure that medical care is provided to a subject for any adverse event(s).Inform a subject when medical care is needed to treat an intercurrent illness(es).Inform the subject's primary physician about their participation in the study.Report all serious adverse events immediately to the sponsor and IRB.Assure that the informed consent form contains all the elements required by CFR 56.Obtain a signed and dated informed consent from the subject or subject's legal representative before initiating any study-related procedures.Inform the subject or legal representative about all aspects of the clinical trial.Provide new information about the study or test article(s).Ensure subject understanding.Provide the subject or subject's legal representative with a copy of the signed and dated informed consent form.Assure that the informed consent form is in language that is understandable to the subject.Secure a witness to the informed consent process when the subject or legal representative is unable to read.Allow ample time and opportunity for the consent process and answering questions about the trial to the satisfaction of the subject or legal representative.Secure consent/assent from minors and mentally impaired subjects as required.Follow emergency use guidelines for waiver of consent in emergency situations as directed by the federal regulations and IRB policy and procedures.Ensure the accuracy, completeness, legibility, and timeliness of case report forms.Ensure that case report forms accurately reflect source documents.Ensure adequate information in source documents.Record all safety data in medical records and report SAEs immediately to the sponsor.RequirementsMedical Licensed in CA.Trained and experienced in clinical research.Familiar with the background of the study drug and requirements of the study.Have high ethical standards and professional integrity.Friendly and outgoing.Must demonstrate a passion for direct patient care.Demonstrate clinical competence, positive leadership, and ability to work collaboratively with a multidisciplinary team.Regular and punctual attendance.Perform other duties as assigned.Embrace Profound’s core values.Travel RequirementsOccasional travel up to 20%.Physical RequirementsProlonged periods of sitting at a desk and working on a computer, standing and walking.Must be able to lift 25 pounds at times.Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound.The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
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