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Principal Investigator Clinical Trials

Company: Evolution Research Group
Location: Rogers
Posted on: November 17, 2022

Job Description:

Title: Principal InvestigatorLocation: WRNJob Description:ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late stage neuroscience drug development. With 22 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.The Principal Investigator ensures adherence to protocol requirements, protecting the rights and welfare of study subjects, assuring the integrity of data generated at the site. In executing these position responsibilities, the Investigator is guided by and promotes the adherence to FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.Responsibilities:Employee Mentoring ResponsibilitiesWorks with the Site Director and Medical Director to provide oversight of Sub-Investigator. Reviews their work to ensure adherence to SOPs, ICH GCP guidelines, and protocol requirements.Protocol Planning and OversightWorks with Site Director, Study Coordinator, and Recruitment Manager to develop effective programs for study enrollmentWorks with Site Director to ensure that all staff are adequately trained and adhere to Standard Operating Procedure and working guidelines while performing study procedures on assigned studies.Works with the Site Director to ensure the site has an adequate number of qualified staff, adequate facilities, and that the PI has adequate time to conduct the studyInvestigator Qualifications and AgreementsMaintain a current, up-to-date curriculum vitaeMaintain current licensure to practiceProvide the sponsor and IRB with documentation of credentials as requestedDemonstrate the proper education, training, and experience to conduct the clinical investigationAssume responsibility for the conduct of the clinical investigationSign the Form FDA 1572 as appropriateSign the protocol as requiredSign sponsor contract(s) as appropriateDocument the financial aspects of the trialDisclosing conflicts of interest as described in the regulationsEnsure Protocol CompliancePossess a thorough understanding of the requirements of each protocolParticipate in sponsor investigator meetings whenever possibleDetermine that inclusion/exclusion criteria are applicable to the study populationEnsure recruitment goals are reasonable and attainable in conjunction with the Site DirectorAssess overall protocol feasibility in conjunction with the Site DirectorFollow the trial's randomization proceduresWill not implement 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 teamEnsure Adequate Review By A Duly Constituted Institutional Review Board ( IRB)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)Secure written IRB approval prior to 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 the IRB with all documents subject to their reviewManage The Care of SubjectsOversee all trial-related medical decisions or ensure that a qualified sub-investigator is available to do so.Assess subject compliance with the test article and follow-up visitsAssess subject's response to therapyEvaluate for adverse experiences per protocol guidelinesEnsure 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 trialProtect The Rights and Welfare Of SubjectsReport all serious adverse events immediately to the sponsor and IRBEnsure that the informed consent form contains all the elements required by regulatory agenciesObtain a signed and dated informed consent from the subject or subject's legal representative prior to initiating any study-related proceduresInform the subject or legal representative about all aspects of the clinical trialProvide new information about the study or test article(s)Ensure Validity of The Data Reported To The SponsorEnsure the accuracy, completeness, legibility, and timeliness of case report formsEnsure that case report forms accurately reflect source documentsExplain any discrepancies between source documents and case report formsEndorse changes or corrections to a case report formEnsure Documentation of Study-Related Procedures, Processes and EventsDocument deviations from the approved protocolDocument and explain premature unblinding of the investigational product(s)Document that informed consent has been obtained from the subject or legal representativeAscertain the reason for a patient's premature study withdrawalDocument adverse experiencesComply with written procedures to document changes to data and/or case report formsMaintain 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 authority(ies)Ensure The Proper Use and Storage Of Investigational AgentsIs thoroughly familiar with the use of the investigational products(s)Read the current investigator's brochure, product insert, or other source informationAssume responsibility for the investigational product at the trial siteEnsure the proper use and storage of the investigational product(s) at the trial siteDelegate responsibility to the appropriate research pharmacy personnel in conjunction with the Site DirectorReview the proper use of the study article(s) by the subject(s)Study CommunicationCommunicate effectively with subjects, research team, IRB and sponsorMeet regularly with the research team to discuss subject participation and protocol progressEnsure that all research staff are informed about the protocol and investigational agentsBe knowledgeable about regulatory requirements and GCP standardsPrepare for and attend investigator start-up meetingsParticipate in monitoring visits and audits as appropriatePermit monitoring and auditing by the sponsor and appropriate regulatory authoritiesMake available to monitors, auditors, IRB and regulatory authority(ies) all requested trial- related recordsDelegate authority at the site appropriatelyEnsure that all research staff are informed about their trail-related duties and functionsMaintain a list of qualified persons and their corresponding trial-related delegated dutiesBusiness DevelopmentWorks with the Site Director and BD team to complete feasibilities, expedite protocol reviews and "Go-No Go" decisions.Evaluates study protocols (e.g., with respect to enrollment/retention potential, site capacity and capabilities, and other determinants of success), and provides input to the Site Director, Recruitment Manager and Clinical Research team, as necessary. Contributes to decision as to which studies to pursue.Attends industry meeting and conferences to represent the site for the purpose of maintaining and building relationships with sponsors and CROsMaintains Professional and Technical KnowledgeAttend educational workshopsReview professional publicationsParticipate in professional societiesSkills and Qualifications:Education and experienceM.D, D.O., or PhD requiredRequirementsAble to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff.Skilled in working with potential sponsors to place research with the site.Works effectively with a staff of clinical professionals and creates a productive, satisfying work environment.Demonstrates the ability to initiate activity as required and making appropriate decisions within the constraints of study protocols and, regulatory requirementsAble to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.Experienced negotiation skillsFormal presentation skillsAbility to perform overnight business travelExcellent persuasive/selling skillsUnderstands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.Knowledgeable in medical terminologyExcellent communication skills (interpersonal, written, verbal)Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)

Keywords: Evolution Research Group, Rogers , Principal Investigator Clinical Trials, Other , Rogers, Arkansas

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