Full Job Description
We are seeking a Casual PA-C or Nurse Practitioner to join our dynamic team at Nucleus Network.
Hours/shift: Casual hours 24-32 a month depending on unit activity.
Company Overview
Nucleus Network is a leading global Phase 1 clinical trial specialist, dedicated to advancing medicine and improving lives. With facilities in the USA and Australia, we have conducted over 1000 Phase 1 clinical trials since our establishment in 2004, partnering with innovative biotechnology and pharmaceutical companies worldwide.
Key Responsibilities
- Providing high quality medical services to participants of clinical trials conducted by Nucleus Network in accordance with FDA Code of Federal Regulations, clinical trial protocols, ICH/GCP and Standard Operating Procedures (SOPs) and all relevant ethical and legal requirements (including the Declaration of Helsinki) with respect to clinical trials.
- To provide and document informed consent to potentially eligible participants and ensure that NO screening procedures occur before a valid Information Consent Form (ICF) has been signed.
- Ensuring participants are consented to the correct ICF including part of study.
- Conducting and documenting thorough medical history / examinations at screening appointments to ensure only potentially eligible participants are enrolled in studies at NN.
- Reviewing and signing off relevant documentation (i.e. Clinical Lab reports, diagnostic results, inclusion /exclusion criteria) in order to deem participants eligible to enrol in studies at NN.
- If required, contacting participants PCP / Specialists for further medical information in order to assess eligibility of participants.
- To medically manage and supervise research on healthy volunteers and patients for trials conducted at NN
- Performing required medical activities as indicated in the Protocol, i.e. Physical examinations, Neuro exams, CSSRS evaluations, Injection site reactions etc.
- Attending to outpatient appointments as required to review participants who are currently participating in a trial and providing medical assistance and advise as required.
- Participating in the review of individual adverse event reports for accuracy and clinical importance, and characterizes their relationship to the study drug, severity and seriousness
- Having an understanding of the potential adverse reactions of all clinical trials being conducted.
- When required, participate in administration of investigational products and on-study activities
- Work collaboratively with all functional department including, Project Management, Recruitment, Resourcing, Screening, Pharmacy and QA Departments.
Requirements
- Medical Practitioner (licensed or eligible PA, NP, ), with qualifications from a recognized institution.
Preferred Qualifications
- Ability to work well within a multi-disciplinary team (which includes clinical and non-clinical staff) is critical
- Enthusiastic, and possess excellent communication skills to facilitate and build good rapport with clinical trial participants
- Previous experience with conducting early phase clinical trials is viewed upon favourably but not essential
- Relevant GCP Training (within 2 years)
- Recent (within 1 years) clinical experience – new graduates with strong medical background encouraged to apply
- Flexible schedule with the ability to accommodate weekend coverage and (rarely) evenings
Job Types: Full-time, Part-time
Pay: $65.00 – $74.00 per hour
Work Location: In person
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