Subinvestigator - Nurse Practitioner/ Physician Assistant - PRN

Celerion; Omaha (NE); On-site; USD 90,000 - 170,000; Full time

Job summary

Celerion seeks skilled healthcare professionals for on-site involvement in Phase I healthy volunteer studies at our Omaha clinic. You will perform screenings, data collection, and safety monitoring under the PI, coordinating with nursing and study management to ensure protocol compliance.

Required are an NP/PA license, DEA certification or willingness to obtain, and relevant clinical or research experience.

Qualifications

• Nurse Practitioner or PA license required.
• DEA certificate for schedule II medications or willingness to obtain.
• BLS and ACLS training, or willingness to obtain.
• Board certified or board eligible in family practice, internal medicine, ER or PA-C/NP.
• 3–5 years medical or clinical research experience preferred.

Responsibilities

• Maintain timely compliance with SOPs and study documentation.
• Assist with training of new staff as needed.
• Create a friendly, welcoming environment for study participants.
• Produce accurate study data while ensuring participant safety.
• Participate in ICF process and answer volunteer questions.
• Conduct screening physical examinations and review screening data.
• Make preliminary eligibility decisions based on protocol criteria.
• Ensure safety by reviewing adverse events and managing care under PI supervision.
• Review safety data and conduct periodic physical examinations during the study.
• Assist in referring participants to specialists when necessary.

Skills

Clinical research

Screening & pre-study coordination

Safety data review

Effective communication

Education

Nurse Practitioner or Physician Assistant license

DEA certificate for schedule II medications

BLS/ACLS training or willingness to obtain

Board certification or eligibility in primary care

3–5 years medical or clinical research experience

Job description

Celerion is committed to swift, exceptional clinical research through translational medicine.Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

Do you have a flexible schedule and enjoy a fast paced environment? Say goodbye to insurance hassles and late-night charting.

Join the exciting world of clinical trials. Be at the forefront of a new drug's journey to market.

Ensure the safety of healthy volunteers in Phase One Research Clinic.

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

Celerion Values: Integrity Trust Teamwork Respect

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

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