Sub l /Nurse Practitioner

Principal Investigator

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 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.

Investigator Qualifications and Agreements

• 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.

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 and CROs.
• Maintain Professional and Technical Knowledge
• Attend educational workshops.
• Review professional publications.
• Participate in professional societies.

Skills and Qualifications:

• Education and experience
  • M.D, D.O., or PhD required.
• Requirements
  • Able to communicate with providers, co-workers, sponsors,