Subinvestigator - Nurse Practitioner/ Physician Assistant - PRN

Essential Functions

• Maintain timely compliance with Celerion’s SOPs, required study documents, and other study- specific mandatory trainings
• Assist with training of new staff upon achieving personal proficiency in required skills and tasks.
• Create a friendly and welcoming environment to study participants
• Produce accurate and timely study data while ensuring participant safety
Pre-study
• Participate in the ICF process by answering any volunteer questions about the study, in collaboration with the investigator as needed.
• Conduct screening physical examinations
• Review subject screening data, including subject medical histories, ECGs, laboratory studies, and any other ancillary tests as outlined by the study protocol.
• Make preliminary eligibility decisions based on protocol inclusion and exclusion criteria.
• Counsel participants regarding abnormal tests and make referrals in collaboration with the investigator as necessary
• Attend Sponsor SIVs
• Assist in the logistical setup of new studies by collaborating with the nursing department and working with study management to ensure the successful execution of all medical aspects of the protocol
• Provide training to clinic associates as needed
• Resolve queries
During study
• Review safety-related data including ECGs, AEs, laboratory data or other ancillary tests in a timely manner
• Conduct physical examinations
• Perform minor procedures as outlined by the protocol following completion of required training
• Engage with client in-person (on-site) or via written, electronic or telephone correspondence to address any medical-related issues
• Ensure safety of study participants by reviewing and managing adverse events and serious adverse events under the supervision of the PI. Perform assessments and administer necessary treatment when required
• Assist in referring participants to specialists as necessary
• Review of outside medical records if requested by the investigator
• Review of SUSAR reports if requested by the investigator
• Resolve queries
Post-study
• Review safety-related data including ECGs, AEs, laboratory data or other ancillary tests in a timely manner
• Conduct physical examinations
• Resolve queries

Knowledge/ Skills/ Education/ Licenses

• Schedule includes one weekday based on candidate preference; approximately 8 hours per week
• This position will work onsite at our Omaha, NE screening location.
• Nurse Practitioner or Physician Assistant license required
• Hold a DEA certificate for schedule II medications or willing to obtain upon hire
• Training in Basic Life Support and Advance Cardiac Life Support, or willing to obtain upon hire
• Board certified or board eligible in a primary care specialty, i.e. family practice, internal medicine, E.R. medicine or as a PA-C or NP
• 3-5 years medical experience and / or clinical research experience
• Clinical research experience preferred