About Scientia Clinical Research Scientia Clinical Research (SCR) is the first publicly funded purpose-built early phase clinical trials centre in NSW. Located in the Bright Alliance Building with 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. About the Role You will assist in all aspects of day-to-day Investigational Product (IP) management for clinical studies as per study protocol and other applicable documents. Ensure activities comply with SCR SOPs and procedures, ICH Good Clinical Practice (GCP), relevant GMP principles (e.g. Annex 2 and 13) and applicable state, federal and global regulatory requirements and guidance. Key Accountabilities / Responsibilities Perform and take responsibility for all aspects of IP management including dispensing and compounding, accountability, returns, receipt and storage of IP for clinical studies as per study protocol and other applicable documents. Participate in areas of study set up as well as study archiving. Review sections of pharmacy manuals where qualified. Apply correct compounding techniques, whether aseptic or non-sterile, to IP compounding or manufacturing. Maintain stock inventory 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. Assist in the preparation of study specific risk management plans as required. Be familiar with all studies currently running within the unit and assist as needed with respect to the preparation and administration of the IP or other medications. Perform administrative and housekeeping duties where required e.g., deep cleans of cleanroom. Meet relevant OH&S requirements. Maintain a clean working environment in all pharmacy areas. About You Minimum of 2 years experience as a pharmacy technician in hospital or community pharmacy Strong interpersonal, verbal and written communication skills (English) and ability to work in a complex, multifunctional team. Ability to work independently and as part of a team. Demonstrated ability to develop and implement systems and procedures and identify process improvement. Good attention to detail, ability to adapt to a fast paced environment, pro-activeness and ability to adhere to documentation guidelines. Demonstrated maturity, professionalism, and integrity with adherence to high ethical standards. Flexibility to work out-side of normal business hours e.g., early mornings, evenings, weekends if required Desirable: Aseptic compounding experience Experience in manufacturing Experience in clinical trial investigational product Knowledge of TGA requirement ICH Good Clinical Practice (GCP) training certification or willingness to obtain
