Sub l /Nurse Practitioner

Sub-Investigator Position

The Sub-Investigator acts as the secondary physician in charge of medical and clinical issues at the clinical research site, acting in place of the Principal Investigator, as requested, or required. Works with the Principal Investigator and the site to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical and a regulatory perspective.

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 Sub-Investigator is guided by and promotes the adherence to Good Clinical Practices (GCP), International Committee on Harmonization (ICH) guidelines, and company standard operating procedures and policies.

Responsibilities:

• Assist in recruitment of additional research studies, especially through professional/clinical, and industry relationships.
• Provide input to the Principal Investigator and/or Site Director about study protocols (e.g., with respect to enrollment/retention potential, office capacity and capabilities, profit potential, and other determinants of success).
• Provide input to the Principal Investigator and/or Site Director as to which studies to pursue.
• Conduct medical office visits with subjects in active studies and ensure compliance with requirements of protocols for said studies.
• Act as liaison with study monitors for active studies.
• Represents ERG at conferences sponsored by potential clients (i.e., pharmaceutical firms) as requested.
• Aid Patient Recruitment personnel in recruiting patients for studies, with a particular emphasis upon working with other physicians and hospitals.
• Ensure proper compliance and execution of the Informed Consent processes.

• 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.

• 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.

• 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.

• 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.

• 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 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.

• 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)

• 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)

• 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.

• 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)