Sub l /Nurse Practitioner

Responsibilities

• Planning and Management
• Assist in recruitment of additional research studies.
• Provide input to the Principal Investigator and/or Site Director about study protocols.
• Conduct medical office visits with subjects in active studies.
• Act as liaison with study monitors.
• Represent ERG at conferences sponsored by potential clients.
• Aid Patient Recruitment personnel in recruiting patients.
• Aid in ensuring proper compliance and execution of the Informed Consent processes.

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.
• Disclose conflicts of interest as described in the regulations.

Adequate Review by A Duly Constituted Institutional Review Board (IRB)

• Provide the IRB with adequate information to initially review the study.
• Provide the IRB with documents for ongoing review.
• Secure written IRB approval prior to initiating the study or instituting any changes to the protocol.
• Provide written summaries of the trial status to the IRB annually, or as requested.
• Provide the IRB with all documents subject to their review.

Management of 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.

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.

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.

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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).

Ensuring the Proper Use and Storage of Investigational Agents

• 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