Job DescriptionCLINICAL RESEARCH (PROJECT)COORDINATOR Role is Avaialble wwith a leading early phase clinical research organisation in Australia, providing an expedited regulatory pathway, the CTN scheme, for the initiation of first-in-human clinical trials without the need for filing an IND.
Its people, facilities and problem-solving culture provide excellent service to more than 100 + global pharmaceutical and biotechnology companies and Hospitals. The organisation is an instrumental part of the process for the development of global investigational products.
The Objectives for this Position are:
The Clinical Research Coordinator (CRC) is responsible for participant management of assigned clinical trials and coordinating all project implementation and conduct tasks are completed in line with the HREC approved protocol and company's policies and procedure, to ensure the expectations and demands of sponsor representatives are being met.Conducts clinical studies for commercial sponsors with specialised focus on early phase studies. This includes healthy volunteer and patient studies.Providing studysupport to Associate/Clinical Project Manager for final approval once study is ready to be archived following the close out visit.
• Prepare essential study documents in line with NN SOPs, including but not limited to: Investigator Site File (ISF), Subject File Source Document (SFSD), Taskpad.
•Send initial admission email to all functional groups at least 24 hours prior to schedule admission.
• Update catering schedule (initially a week prior to admission, and update in real time when applicable)
• Attend the unit at least one hour prior to dosing and remain in the unit or available until dosing has been completed in order to assist and oversee unit procedures, and to engage with participants.
•Act as the primary point of contact for Clinical Research Associates (CRA) to book in monitoring visits and be available to monitors during their monitoring visits
• Organise prescriptions, collection tube racks, and wrist bands.
• Discharge alternate participants (if applicable) once dosing has completed.
• Update dosing details on subject tracking log and on-study taskpads once dosing has completed.
• Send notification email on dosing information to relevant functional areas once dosing has been completed.
• Print blood results of sample collection or when results are available, in line internal SOPs. Including, organising repeat visits where required.
• Set-up (Collection tubes, Pathology kits/forms) for outpatient visits the day prior to visit, if applicable.
• Ensure site files are complete and all queries answered for database lock/close-out visit.Ensure ongoing compliance of all documents and procedures with ICH GCP guidelines and as per Standard Operating Procedures.
• Ensure Learning and Development requirements are maintained with new or updated Training Records completed within one week of implementation.
• Complete all clinical trial documentation in a contemporaneous, accurate and legible manner in accordance with ICH-GCP.
• Establish a good rapport with the volunteers, while behaving in a professional manner at all times.
• Monitor and accurately documenting adverse events / concomitant medications according tocompany's SOPs or the protocol requirements
• Participate in collection, and where required; processing, storage and tracking of biological samples.
Mandatory qualifications, competencies and experience for this position are:
• Tertiary qualification in related science or health care discipline.
• At least one year of clinical research experience and working knowledge of relevant standards, procedures and regulations, including ICH GCP.
• A high level of interpersonal skills, including verbal and written communication skills.
Desired qualifications, competencies and experience for this position are:
• Previous experience in clinical trial study coordination ideally from a pharmaceutical /CRO.
• Previous phase I clinical trials experience would be pereffered.
APPLY: Please send your resume at faiza. khan @ nesgt .com or call for a confidential chat at 02-96968008.(Faiza Khan Poit of contact)