Sub Investigator - 211696

Position Description: 1. PROVIDES INVESTIGATOR QUALIFICATIONS AND AGREEMENTS By:Maintaining a current, up-to-date curriculum vitaeMaintaining current licensure to practiceProviding 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 investigationSigning the Form FDA 1572 as appropriateSigning the protocol as requiredSigning sponsor contract(s) as appropriateDocumenting the financial aspects of the trialDisclosing conflicts of interest as described in the regulations

• ENSURES PROTOCOL COMPLIANCE By:Possessing a thorough understanding of the requirements of each protocolDetermining that inclusion/exclusion criteria are applicable to the study populationEnsuring 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, end point criteria and investigational article use with the research team
• ENSURES INITIAL AND ONGOING REVIEW BY A DULY CONSTITUTED IRB By: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)Securing written IRB approval prior to initiating the study or instituting any changes to the protocol as approvedProviding written summaries of the trial status to the IRB annually, or as requestedProviding the IRB with all documents subject to their review
• DETERMINES ADEQUATE RESOURCES ARE AVAILABLE TO CONDUCT THE STUDYBy:Having adequate number of qualified staff to conduct the studyHaving adequate facilities to conduct the studyEnsuring he/she has adequate time to conduct and supervise the study
• MANAGES THE MEDICAL CARE OF SUBJECTS By:Ensuring 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 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 trial
• PROTECTS THE RIGHTS AND WELFARE OF SUBJECTS By:Reporting all serious adverse events immediately to the sponsor and IRBEnsuring that the informed consent form contains all the elements required by CFG 56 and 45Obtaining a signed and dated informed consent from the subject or subject's legal representative prior to initiating any study-related proceduresInforming the subject or legal representative about all aspects of the clinical trialProviding new information about the study or rest article(s)7. ENSURES VALIDITY OF THE DATA REPORTED TO THE SPONSORBy: 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 form
• ENSURES DOCUMENTATION OF STUDY-RELATED PROCEDURES, PROCESSES ANDEVENTS 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 experiencesComplying 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 time frame and under secure conditionsProviding study reports as requested by the sponsor, IRB and regulatory authority(ies)
• ENSURES THE PROPER USE AND STORAGE OF INVESTIGATIONAL AGENTS By:Being thoroughly familiar with the use of the investigational products(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 siteAssigning responsibility tot he appropriate research pharmacy personnelReviewing the proper use of the study article(s) by the subject(s)
• DIRECTS SITE OPERATIONSCommunicating effectively with subjects, research team, IRB and sponsorMeeting regularly with the research team to discuss subject participation and protocol progressEnsuring 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 authority(ies) all requested trail-related recordsDelegating authority at the site appropriatelyEnsuring that all research staff are informed about their trail-related duties and functionsMaintaining a list of qualified persons and their corresponding trial-related delegated duties