Principal Investigator Clinical Trials

Benefits

Qualifications

• •Education and experience
• •M.D, D.O., or PhD required
• •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, regulatory requirements
• •Experienced negotiation skills
• •Formal presentation skills
• •Ability to perform overnight business travel
• •Excellent persuasive/selling skills
• •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)
• •12 more items(s)

Responsibilities

• •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
• •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 study enrollment
• •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 the study
• •Maintain a current, up to date curriculum vitae
• •Maintain current licensure to practice
• •Provide the sponsor and IRB with documentation of credentials as requested
• •Demonstrate the proper education, training, and experience to conduct the clinical investigation
• •Assume responsibility for the conduct of the clinical investigation
• •Sign the Form FDA 1572 as appropriate
• •Sign the protocol as required
• •Sign sponsor contract(s) as appropriate
• •Document the financial aspects of the trial
• •Disclosing conflicts of interest as described in the regulations
• •Ensure Protocol Compliance
• •Possess a thorough understanding of the requirements of each protocol
• •Participate in sponsor investigator meetings whenever possible
• •Determine that inclusion/exclusion criteria are applicable to the study population
• •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 randomization procedures
• •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 research team
• •Ensure Adequate Review by the 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 approved
• •Provide written summaries of the trial status to the IRB annually, or as requested
• •Provide the IRB with all documents subject to their review
• •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-up visits
• •Assess subject's response to therapy
• •Evaluate for adverse experiences per protocol guidelines
• •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 the trial
• •Protect the rights and welfare of Subjects
• •Report all serious adverse events immediately to the sponsor and IRB
• •Ensure that the informed consent form contains all the elements required by regulatory agencies
• •Obtain a signed and dated informed consent from the subject or subject's legal representative prior to initiating any study-related procedures
• •Inform the subject or legal representative about all aspects of the clinical trial
• •Provide new information about the study or test article(s)
• •Ensure validity of the data reported to the Sponsor
• •Ensure the accuracy, completeness, legibility, and timeliness of case report forms
• •Ensure that case report forms accurately reflect source documents
• •Explain any discrepancies between source documents and case report forms
• •Endorse changes or corrections to a case report form
• •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 legal representative
• •Ascertain the reason for a patient's premature study withdrawal
• •Document adverse experiences
• •Comply with written procedures to document changes to data and/or case report forms
• •Maintain trial documents as required by the regulations and sponsor for the appropriate timeframe and under secure conditions
• •Provide study reports as requested by the sponsor, IRB, and regulatory authority(ies)
• •Ensure the proper use and storage of investigational agents
• •Thoroughly familiar with the use of the investigational product(s)
• •Read the current investigator's brochure, product insert, or other source information
• •Assume responsibility for the investigational product at the trial site
• •Ensure the proper use and storage of the investigational product(s) at the trial site
• •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, and sponsor
• •Meet regularly with the research team to discuss subject participation and protocol progress
• •Ensure that all research staff are informed about the protocol and investigational agents
• •Knowledgeable about regulatory requirements and GCP standards
• •Prepare for and attend investigator start-up meetings
• •Participate in monitoring visits and audits as appropriate
• •Permit monitoring and auditing by the sponsor and appropriate regulatory authorities
• •Make available to monitors, auditors, IRB, and regulatory authority(ies) all requested trial- related records
• •Delegate authority at the site appropriately
• •Ensure that all research staff are informed about their trail-related duties and functions
• •Maintain a list of qualified persons and their corresponding trial-related delegated duties
• •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 and CROs
• •Maintain Professional and Technical Knowledge
• •Attend educational workshops
• •Participate in professional societies
• •85 more items(s)