Job Title

JOB SUMMARYThe Principal Investigator (PI) promotes good clinical practices in the conduct of clinical investigations by assuring adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of data generated at the site, and directing the conduct of the clinical investigation according to federal and state regulations and guidance documents. The Principal Investigator assumes full responsibility for the conduct of the clinical trial and may delegate responsibilities in accordance with GCPs when approved by the Chief Operating Officer.RESPONSIBILITIESProvides Investigator Qualifications and Agreements by:Maintaining a current, up-to-date curriculum vitaeMaintaining current licensure to practiceMaintaining a current DEA licenseProvide the sponsor and IRB with documentation of credentials as requestedDemonstrating the proper education, training, and experience to conduct the clinical investigationAssuming responsibility for the conduct of the clinical investigationExecution of Form FDA 1572 for each study, and compliance with Form FDA 1572 requirements forExecution of the protocol signature page, as requiredSubmission of financial disclosure form(s) before, during, and after studySigning sponsor contract(s) as appropriateDocumenting the financial aspects of the trial in accordance with the Sunshine ActDisclosing conflicts of interest as described in the regulationsAssures Protocol Compliance by:Possessing a thorough understanding of the requirements of each protocolDetermining that inclusion/exclusion criteria apply to the study populationAssuring recruitment goals are reasonable and attainableAssessing overall protocol feasibilityFollowing the trial's randomization proceduresNot 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)Reviewing the inclusion/exclusion criteria, schedule of visits, endpoint criteria, and investigational article use with the research teamAssures Initial and Ongoing Review by a Duly Constituted IRB by:Provide 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)Provide the IRB with documents for ongoing review (i.e., amendments to the protocol, adverse events, deviations, or new information)Securing written IRB approval before initiating the study or instituting any changes to the protocol as approvedProvide written summaries of the trial status to the IRB annually, or as requestedProvide written information of premature termination or suspension of a trialProvide the IRB with all documents subject to their reviewDetermines Adequate Resources are Available to Conduct the Study by:Having an adequate number of qualified staff to conduct the studyHaving an adequate facility to conduct the studyAssuring he/she has adequate time to conduct and supervise the studyManages the Medical Care of Subjects by:Assuring that a qualified physician (PI or sub-investigator) is responsible for all trial-related medical decisionsAssessing subject compliance with the test article and follow-up visitsAssessing the subject's response to therapyEvaluating for adverse experiencesEnsuring 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 trialProtects the Rights and Welfare of Subjects by:Reporting all serious adverse events immediately to the sponsor and IRBAssuring that the informed consent form contains all the elements required by CFR 56 and 45Obtaining a signed and dated informed consent from the subject or the subject's legal representative before initiating any study-related proceduresInforming the subject or legal representative about all aspects of the clinical trialProviding new information about the study or test article(s)Ensuring subject confidentialityProviding the subject or subject's legal representative with a copy of the signed and dated informed consent formAssuring that the informed consent form is in language that is understandable to the subjectSecuring a witness to the informed consent process when the subject or legal representative is unable to readAllowing ample time and opportunity for the consent process and answering questions about the trial to the satisfaction of the subject or legal representativeSecuring consent/assent from minors and mentally impaired subjects as appropriateFollowing emergency use guidelines for waiver of consent in emergencies as directed by the federal regulations and IRB policy and proceduresAssures Validity of the Data Reported to the Sponsor by:Ensuring the accuracy, completeness, legibility, and timeliness of case report formsEnsuring that case report forms accurately reflect source documentsExplaining any discrepancies between source documents and case report formsEndorsing changes or corrections to a case report formAssures Documentation of Study-Related Procedures, Processes, and Events by:Documenting deviations from the approved protocolDocumenting and explaining premature unblinding of the investigational product(s)Documenting that informed consent has been obtained from the subject or legal representativeAscertaining the reason for a patient's premature study withdrawalDocumenting adverse events and or medication side effectsComplying with written procedures to document changes to data and/or case report formsMaintaining trial documents as required by the regulations and sponsor for the appropriate timeframe and under secure conditionsProvide study reports as requested by the sponsor, IRB, and regulatory authoritiesAssures the Proper Use and Storage of Investigational Agents by:Being thoroughly familiar with the use of the investigational product(s)Reading the current investigator's brochure, product insert, or other source informationAssuming responsibility for the investigational product at the trial siteEnsuring the proper use and storage of the investigational product(s) at the trial siteReviewing the proper use of the study article(s) by the subject(s)Assists Site Operations by:Communicating effectively with subjects, research team, IRB, and sponsorMeeting regularly with the research team to discuss subject participation and protocol progressAssuring that all research staff are informed about the protocol and investigational agentsBeing knowledgeable about regulatory requirements and GCP standardsPreparing for and attending investigator and start-up meetingsParticipating in monitoring visits and audits as appropriatePermitting monitoring and auditing by the sponsor and appropriate regulatory authoritiesMaking available to monitors, auditors, IRB, and regulatory authorities all requested trial-related recordsDelegating authority at the site appropriatelyAssuring that all research staff are informed about their trial-related duties and functionsMaintaining a list of qualified persons and their corresponding trial-related delegated dutiesMaintains Professional and Technical Knowledge by:Attending educational workshopsReviewing professional publicationsParticipating in professional societiesOther duties as assignedTRAVELINGTravel to investigator meetings and to sponsor offices or other locations as needed.Salary ranges between $200k to $300k.Requirements Must have MD or DO degree Must have a NJ medical license.3-5 years of clinical research experience, with a focus on industry-sponsored clinical trials Must have Phase 1 experience.CNS clinical trial experience is preferred.Training in Advance Cardiac Life Support.Board certified or board eligible in a primary care specialty, (e.g., internal medicine, psychiatry, emergency medicine) Excellent team player Good problem-solving skills are required in identifying, resolving, and alerting others to operational problems Good verbal and written communication skills Excellent organizational and time management skills