Subinvestigator - Nurse Practitioner/ Physician Assistant - Part-time (30 hrs)
PharmaPharmacovigilanceClinical Research
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; 30 hrs/week; mornings Mon-Fri; weekend rotation availability
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
This is not a remote position.
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