Sub l /Nurse Practitioner

• 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
• 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.
• 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 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 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
• Assess subject compliance with the test article and follow-up visits.
• Assess subject's response to therapy.
• Evaluate 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 explaining 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(is)

• Ensure the Proper Use and Storage of Investigational Agents
• Being thoroughly familiar with the use of the investigational products(s)
• Read the current investigator's brochure, product insert, or other source information.
• Assume responsibility for the investigational product at the trial site (when necessary)
• Ensure the proper use and storage of the investigational product(s) at the trial site.
• Assign responsibility to the appropriate research pharmacy personnel.
• Review the proper use of the study article(s) by the subject(s)

• Direct Site Operations
• Communicate effectively with subjects, research team, IRB, and sponsor.
• Ensure that all research staff are informed about the protocol and investigational agents.
• Be knowledgeable about regulatory requirements and GCP standards.
• Prepare for and attending investigator and start-up meetings whenever necessary.
• 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 authorities 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.

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

Skills and Qualifications

• Education and experience
• NP required
• Experience as a Sub-Investigator in industry-sponsored clinical trials preferred.
• Requirements
• Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
• Knowledgeable in medical terminology
• Skilled in persuading potential sponsors to place research with the site.
• Demonstrate the initiative to act independently, initiate activity as required and make appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
• 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 business travel.
• Excellent persuasive/selling skills.
• Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
• 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)