Scientia Clinical Research (SCR) is the first publicly funded, purpose built, early phase clinical trials centre in NSW. Our state-of-the-art facility is located in the Bright Alliance Building within the Nelune Comprehensive Cancer Care Centre and services of the Sydney Children’s Hospital. Co-located in a major research precinct with Prince of Wales Hospital, Royal Hospital for Women, UNSW Sydney and the Lowy Cancer Research Centre. The highly experienced, multifunctional, Scientia Clinical Research team consists of Medical, Clinical, Nursing, Pharmacy, Laboratory, Quality and Data Management professionals. The team specialise in the conduct of early phase oncology and healthy volunteer clinical trials
Tasks & responsibilities
Perform and take responsibility for all aspects of day-to-day IP management for clinical studies, including dispensing and/or compounding Investigational Products (IP), aseptic preparation, IP accountability, returns and storage.
Participate in areas of study set-up, including pharmacy manual review, study specific IP Risk Management Plans and ensuring that all essential documentation have been received.
Comply with relevant SCR SOPs and procedures, ICH Good Clinical Practice (GCP), relevant GMP principles (e.g. Annex 2 and 13), OH&S, and applicable state, federal and global regulatory requirements and guidance.
Maintain and manage S4 and S8 Stock Drugs, and other stock drugs in accordance with regulatory requirements and as per SCR SOPs
Liaison with any external vendor as required, including Prince of Wales Hospital (POWH) Pharmacy.
Support the IP Manager in providing training to other staff
Provide information and advice to SCR study teams and unit staff regarding drug interactions, side effects, dosage and proper medication administration and storage as well as general IP advice to SCR staff and clients.
Order and purchase pharmaceutical supplies, medical supplies, and drugs, maintain stock including storing and handling according to standard procedures, Poisons and Therapeutics Goods Act, Poisons and Therapeutics Goods Regulations and all other applicable regulations, guidelines and policies.
Be familiar with all studies currently running within the SCR unit and assist as needed in particular with respect to the preparation and administration of the IP or other medications.
Liaise with Clinical Research Associates/Monitors and Sponsors with regards to pharmacy aspects of SCR clinical trials.
Qualifications & experience
Current Registration with the Australian Health Practitioner Regulation Agency
Preferably: Experience in clinical trial investigational product
Preferably: Understanding of applicable cGMP sections (Annex 2 and13) and USP Compounding Comprehendium
Preferably: Knowledge of TGA requirements
Preferably: Aseptic and non-sterile Compounding experience
A Not For Profit Organisation offering salary packaging benefit entitlements.
Located in Randwick, next to Light Railway with good public transport facilities and easy access to local shops and cafes.