Principal Investigator, Clinical Trials (PRN)

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Principal Investigator, Clinical Trials (PRN) PRN CPMI-Clinical Pharmacology Miami, Miami, FL, US 30+ days ago Requisition ID: 1439 About Company: Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. Job Description: 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 Responsibilities Work with the Site Director and Medical Director to provide oversight of Sub-Investigator. Review work to ensure adherence to SOPs, ICH GCP guidelines, and protocol requirements. Protocol Planning and Oversight Work with Site Director, Study Coordinator, and Recruitment Manager to develop effective programs for studyenrollment. Work 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. Work 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 thestudy. Investigator Qualifications and Agreements Maintain a current, up to datecurriculum vitae. Maintain current licensure topractice. Provide the sponsor and IRB with documentation of credentials asrequested. Demonstrate the proper education, training, and experience to conduct the clinicalinvestigation. Assume responsibility for the conduct of the clinicalinvestigation. Sign the Form FDA 1572 asappropriate. Sign the protocol asrequired. Sign sponsor contract(s) as appropriate Document the financial aspects of the trial Disclosing conflicts of interest as described in theregulations. Ensure Protocol Compliance Possess a thorough understanding of the requirements of eachprotocol. Participate in sponsor investigator meetings wheneverpossible. Determine that inclusion/exclusion criteria are applicable to the studypopulation. Ensure recruitment goals are reasonable and attainable in conjunction with the Site Director Assess overall protocol feasibility in conjunction with the Site Director Follow the trial's randomizationprocedures. Will 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 researchteam. Ensure Adequate Review bythe 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 asapproved. Provide written summaries of the trial status to the IRB annually, or asrequested. Provide the IRB with all documents subject to theirreview. Manage The Care of Subjects Oversee 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-upvisits. Assess subject's response totherapy. Evaluate for adverse experiences per protocolguidelines. Ensure 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 thetrial. Protect the rights and welfare ofSubjects Report all serious adverse events immediately to the sponsor andIRB. Ensure that the informed consent form contains all the elements required by regulatoryagencies. Obtain a signed and dated informed consent from the subject or subject's legal representative prior to initiating any study-relatedprocedures. Inform the subject or legal representative about all aspects of the clinicaltrial. Provide new information about the study or test article(s) Ensure validity of the data reported totheSponsor Ensure the accuracy, completeness, legibility, and timeliness of case reportforms. Ensure that case report forms accurately reflect sourcedocuments. Explain any discrepancies between source documents and case reportforms. Endorse changes or corrections to a case reportform. Ensure documentation of study-related procedures, processes and events Document deviations from the approved protocol Document and explain premature unblinding of the investigational product(s) Document that informed consent has been obtained from the subject or legalrepresentative. Ascertain the reason for a patient's premature studywithdrawal. Comply with written procedures to document changes to data and/or case reportforms. Maintain trial documents as required by the regulations and sponsor for the appropriate timeframe and under secureconditions. Provide study reports as requested by the sponsor, IRB, and regulatory authority(ies) Ensure the proper use and storage ofinvestigational agents Thoroughly familiar with the use of the investigational product(s) Read the current investigator's brochure, product insert, or other sourceinformation. Assume responsibility for the investigational product at the trialsite. Ensure the proper use and storage of the investigational product(s) at the trialsite. Delegate responsibility to the appropriate research pharmacy personnel in conjunction with the Site Director Review the proper use of the study article(s) by the subject(s) Study Communication Communicate effectively with subjects, research team, IRB, andsponsor. Meet regularly with the research team to discuss subject participation and protocolprogress. Ensure that all research staff are informed about the protocol and investigationalagents. Knowledgeable about regulatory requirements and GCP standards Prepare for and attend investigator start-upmeetings. Participate in monitoring visits and audits asappropriate. Permit monitoring and auditing by the sponsor and appropriate regulatory authorities Make available to monitors, auditors, IRB, and regulatory authority(ies) all requested trial- relatedrecords. Delegate authority at the site appropriately Ensure that all research staff are informed about their trail-related duties andfunctions. Maintain a list of qualified persons and their corresponding trial-related delegatedduties. Business Development Work with the Site Director and BD team to complete feasibilities, expedite protocol reviews and “Go-No Go” decisions. Evaluate study protocols (e.g., with respect to enrollment/retention potential, site capacity and capabilities, and other determinants of success), and provide input to the Site Director, Recruitment Manager and Clinical Research team, as necessary. Contribute to decision as to which studies to pursue. Attend industry meetings and conferences to represent the site for the purpose of maintaining and building relationships with sponsors andCROs. Maintain Professional and Technical Knowledge Attend educationalworkshops. Review professionalpublications. Participate in professionalsocieties. Skills and Qualifications: Education and experience M.D, D.O., or PhDrequired. Requirements Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner. Knowledgeable in medical terminology to communicate with physician office and laboratory staff. Skilled in working with potential sponsors to place research with the site. Work effectively with a staff of clinical professionals and creates a productive, satisfying work environment. Demonstrate the ability to initiate activity as required and making appropriate decisions within the constraints of study protocols and, regulatoryrequirements. Able to initiate or modify behavior to achieve desired outcomes despite environmental factors, priorities, or problems that might not be well defined or that are subject to change. Experienced negotiation skills Formal presentation skills Ability to perform overnight businesstravel. Excellent persuasive/sellingskills. Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines. Knowledgeable in medical terminology Excellent 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) #J-18808-Ljbffr Ergclinical