Medical Officer for Clinical Trials

2 weeks ago

Herston, Australia Boehunter Full time

General description of the Functional Area: The Medical Department is staffed by the Medical Director and other full-time or part-time Medical Officers. The objectives of the Medical Department include: 1. Provision of high-quality clinical medical services to participants enrolled in clinical trials at Nucleus Network. 2. Performance of Principal Investigator and Co-investigator roles for clinical trials at Nucleus Network to the standards of ICH GCP. 3. Effective evaluation and management of adverse events associated with clinical trials to ensure that safety is optimised for trial participants.

The Objectives for this Position are: Provide high quality screening medical services to participants of clinical trials conducted by Nucleus Network in accordance with protocols, ICH GCP and NN SOPs.

The key responsibilities of this position are: - Providing high quality medical services to participants of clinical trials conducted by Nucleus Network in accordance with clinical trial protocols, Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs). - To comply with rules of the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) as annotated by the Australian Therapeutic Goods Administration (TGA), and all relevant ethical and legal requirements (including the Declaration of Helsinki) with respect to clinical trials. - Complying where necessary with the Alfred Health, Nucleus Network and other Health agency policies and SOPs. - Being Co-investigator on delegated NN clinical studies. - When assigned by the Medical Director, act as Principal Investigator for healthy volunteer studies. - To provide and document informed consent to potentially eligible participants and ensure that NO screening procedures occur before a valid Participant Information Consent Form (PICF) has been signed. - Ensuring participants are consented to the correct PICF including part of study (i.e. MAD / SAD) in line with the NN Participant Informed Consent SOP. - During screening, checking valid participant identification to ensure it matches the signature / name of the signing participant. - Conducting and documenting thorough medical history / examinations at screening appointments to ensure only potentially eligible participants are enrolled in studies at NN. - Reviewing and updating the Subject Management System (SMS) with new or updated medical history information of participants. - 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, liaising with participants GP / Specialists for further medical information in order to assess eligibility of participants. - If required, referring participants to GP / Specialists for medical follow-up in the event of abnormal clinical findings outside the scope of the clinical trials. (i.e. Abnormal screening clinical labs, specialist follow up for Adverse Events) - Signing eligible participant clinical trial prescriptions for Investigational product. - If within scope of medical practise, Prescribing required concomitant medications to 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, 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. - Counselling all potential participants who are required to undergo HIV / Hepatitis testing as part of clinical trial screening. - Participating in the review of individual adverse event reports for accuracy and clinical importance, and characterises their relationship to the study drug, severity and seriousness - Having an understanding of the potential adverse reactions of all clinical trials being conducted. - Provide leadership in clinical emergency situations. - 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. - Participating in feasibility reviews and providing feedback on clinical trial protocols to ensure seamless and safe conduct of proposed clinical activities. - Providing medical input and review of study documents, i.e. Medical officer specific SFSD pages in liaison with functional departments as appropriate - Participating in the Medical Officer on-call phone roster. - To have an awareness of the operational / logístical requirements of all clinical trials conducted. - Participating in quality system development, NN study audits and third party (vendor audits) involving the clinical unit as required by the NN Quality Department.

**Job Types**: Full-time, Part-time

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