Physician- Principal Investigator (Oceanside, CA)
Profound Research
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Posted on Mar 12, 2025
Profound Research:
Profound Research seeks to drive clinical innovation by partnering with community physicians to offer clinical research as a therapeutic option to their patients. Profound enables providers with the right people and tools to launch clinical research operations, often for the first time, to offer new care pathways to patients. Profound Research is looking to grow its energetic team inspired by changing how patients and providers engage in clinical research.
Our Mission: Improving Lives by Providing Advanced Therapeutic Options
Our Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research
Our Values:
Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions.
Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues.
Solution Orientation: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions.
Excellence: We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards.
Profound Ethos
o Physicians are the Vanguard
o All Decisions Improve Patient Care
o Never Compromise Quality
Role: (PI) Principal Investigator
Company: Profound Research
Location: Oceanside, CA
Why this Role Exists
Promote 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 vita
-Maintain current licensure to practice
-Provide the sponsor and institutional review board (IRB) with documentation of credentials as requested.
-Demonstrate the proper education, training and experience to conduct the clinical investigation.
-Assume responsibility for the conduct of the clinical investigation.
-Sign the form FDA 1572 as appropriate.
-Sign the protocol as required
-Sign sponsor contract(s) as appropriate.
-Document the financial aspects of the trial.
-Disclose conflicts of interest as described in the regulations.
-Possess a thorough understanding of the requirements of each protocol.
-Determine that inclusion/exclusion criteria are applicable to the study population.
-Assure recruitment goals are reasonable and attainable.
-Assess overall protocol feasibility.
-Follow the trial's randomization procedures.
-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 forms.
-Endorsing changes or corrections to a case report form.
-Documenting deviations from the approved protocol.
-Documenting and explaining premature unblinding of the investigational product(s).
-Documenting that informed consent has been obtained from the subject or legal representative.
-Ascertaining the reason for a patient's premature study withdrawal.
-Documenting adverse experiences.
-Complying with written procedures to document changes to data and/or case report forms.
-Providing study reports as requested by the sponsor, IRB and regulatory authority(ies).
-Being thoroughly familiar with the use of the investigational product(s).
-Reading the current investigator's brochure, product insert, or other source information.
-Assuming responsibility for the investigational product at the trial site.
-Ensuring the proper use and storage of the investigational product(s) at the trial stie.
-Reviewing the proper use of the study article(s) by the subject(s).
-Communicating effectively with subjects, research team, IRB and sponsor.
-Meeting regularly with the research team to discuss subject participation and protocol progress.
-Assuring that all research staff are informed about the protocol and investigational agents.
-Being knowledgeable about regulatory requirements and GCP standards.
-Preparing for and attending investigator and start-up meetings.
-Participating in monitoring visits and audits as appropriate.
-Permitting monitoring and auditing by the sponsor and appropriate regulatory authorities.
-Making available to monitors, auditors, IRS and regulatory authority(ies) all requested trial- related records.
-Delegating authority at the site appropriately.
-Assuring that all research staff are informed about their trial-related duties and functions.
-Maintaining a list of qualified persons and their corresponding trial-related delegated duties.
-Retaining overall responsibility for the trial
-Documenting every study related action to show that the study is in complies with all guidelines and is a credible trial.
-Ensuring data quality by confirming that data is diligently collected, recorded, and amended accurately.
-Securing written IRB approval before initiating the study or instituting any changes to the protocol as approved.
-Providing written summaries of the trial status to the IRB annually, or as requested.
-Providing written information of premature termination or suspension of a trial.
-Providing the IRB with all documents subject to their review.
-Determine adequate resources as available to conduct the study by assuring he/she has adequate time to conduct and supervise the study
-Assuring that a qualified physician (Pl or sub investigator) is responsible for all trial-related medical decisions.
-Assessing subject compliance with the test article and follow-up visits
-Assessing subject's response to therapy.
-Evaluating for adverse experiences.
-Ensuring that medical care is provided to a subject for any adverse event(s).
-Informing a subject when medical care is needed to treat an intercurrent illness(es).
-Informing the subject's primary physician about their participation in the trials.
-Reporting all serious adverse events immediately to the sponsor and IRB.
-Assuring that the informed consent form contains all the elements required by CFR56 and 45.
-Obtaining a signed and dated informed consent from the subject or subject's legal representative before initiating any study-related procedures.
-Informing the subject or legal representative about all aspects of the clinical trial.
-Providing new information about the study or test article(s).
-Ensuring subject confidentiality.
-Providing the subject or subject's legal representative with a copy of the signed and dated informed consent form.
-Assuring that the informed consent form is in language that is understandable to the subject.
-Securing a witness to the informed consent process when the subject or legal representative is unable to read.
-Allowing ample time and opportunity for the consent process and answering questions about the trial to the satisfaction of the subject or legal representative.
-Securing consent/assent from minors and mentally impaired subjects as appropriate.
-Following emergency use guidelines for waiver of consent in emergency situations as directed by the federal regulations and IRB policy and procedures.
-Ensuring the accuracy, completeness, legibility and timeliness of case report forms.
-Ensuring that case report forms accurately reflect source documents.
-Ensuring adequate information in source documents.
-Record all safety data in medical records and report SAEs immediately to sponsor.
Requirements
-Medical Licensed in CA
-Trained and experienced in clinical
-Familiar with the background of the study drug and requirements of the study.
-Have high ethical standards and professional honesty.
-Friendly and outgoing demeanor.
-Must demonstrate a passion for direct patient interaction.
-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 Requirements
Occasional travel up to 20%
Physical Requirements
· Prolonged 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.
This job is no longer accepting applications
See open jobs at Profound Research.See open jobs similar to "Physician- Principal Investigator (Oceanside, CA)" Rubicon Founders.