Physician- Principal Investigator (Oceanside, CA)

Profound Research

Profound Research

Oceanside, CA, USA
Posted on Tuesday, July 9, 2024
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 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
-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 with the use of the investigational product(s).
-Reading the current investigator's brochure, product insert, or other source
-Assuming responsibility for the investigational product at the trial
-Ensuring the proper use and storage of the investigational product(s) at the trial
-Reviewing the proper use of the study article(s) by the subject(s).
-Communicating effectively with subjects, research team, IRB and
-Meeting regularly with the research team to discuss subject participation and protocol
-Assuring that all research staff are informed about the protocol and investigational
-Being knowledgeable about regulatory requirements and GCP
-Preparing for and attending investigator and start-up
-Participating in monitoring visits and audits as
-Permitting monitoring and auditing by the sponsor and appropriate regulatory
-Making available to monitors, auditors, IRS and regulatory authority(ies) all requested trial- related records.
-Delegating authority at the site
-Assuring that all research staff are informed about their trial-related duties and
-Maintaining a list of qualified persons and their corresponding trial-related delegated
-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
-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
-Providing written information of premature termination or suspension of a
-Providing the IRB with all documents subject to their
-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
-Assessing subject's response to
-Evaluating for adverse
-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
-Reporting all serious adverse events immediately to the sponsor and
-Assuring that the informed consent form contains all the elements required by CFR56 and
-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
-Providing new information about the study or test article(s).
-Ensuring subject
-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
-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
-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
-Ensuring that case report forms accurately reflect source
-Ensuring adequate information in source
-Record all safety data in medical records and report SAEs immediately to
Requirements
-Medical Licensed in CA
-Trained and experienced in clinical
-Familiar with the background of the study drug and requirements of the
-Have high ethical standards and professional
-Friendly and outgoing
-Must demonstrate a passion for direct patient
-Demonstrate clinical competence, positive leadership and ability to work collaboratively with a multidisciplinary team.
-Regular and punctual
-Perform other duties as
-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.