Nucleus Network StaffClinical Trials such as those conducted by Nucleus Network require an extraordinary degree of skill, expertise, care and diligence. Each Sponsor is assigned an experienced project manager and a dedicated, study-specific research co-ordinator. Working closely with major hospital-based principal investigators, Nucleus Network's service and commitment is unparalleled. Some of the brightest minds and greatest talent from Australia work together at Nucleus Network.
Nucleus Network team has the breadth and depth of capabilities and experience to assist Sponsors to anticipate obstacles, avoiding them whenever possible, and provides real-world solutions. Solutions that implement world-class clinical research thinking necessary to bring product development projects closer to commercialisation. Our team is dedicated to world-class clinical research.
Management team
The core management team of Nucleus Network provides excellence and experience in clinical trial conduct and clinical research consulting.
Medical Facility
The facility is staffed by onsite medically qualified personnel whose responsibilities include medical assessment and supervision of trial participants throughout the clinical trials process. Medical staff liaise with other treating physicians, general practitioners and investigators as determined by study protocol requirements and standard operating procedures. In addition, medical personnel hold positions at the Alfred Hospital and other Australian and international medical institutions, including public and private hospitals.
Therapeutic area specific specialists and medical personnel act as principal investigators or co-investigators in studies conducted at the Centre for Clinical Studies following ethics approval for trials.
Clinical Operations
The facility is staffed by medical, scientific, nursing personnel, project managers and clinicians with clinical trial management and operational expertise who collectively have many years of experience in conducting industry standard clinical research. Staff include specialist research nurses with national and international clinical research experience.
Our staff plan, implement and conduct clinical trials and liaise directly with companies and institutional representatives, including auditors and monitors.
Regulatory Affairs and Quality Assurance
The Regulatory Affairs and Quality Assurance Department has multifaceted experience in the pharmaceutical, biologicals and medical devices industries working with large and small companies on total company, regulatory and quality system compliance to global regulatory agency standards including the Food Drug and Administration, European Union and Therapeutic Goods Administration. Expertise includes preparation of quality, manufacturing, marketing, regulatory and clinical operations documentation for global compliance, providing Sponsors with sound advice and assurance for strategic regulatory planning from product development through to marketing authorisation.
Education and Training
The Education and Training Department draws on expert and quality trainers in clinical trials, collaborating with Australian and international education groups to provide a global and thorough career development option for clinical researchers. With many years experience in designing and conducting training programs, this department offers opportunities ranging from careers advice, work experience, basic sessions and courses to post graduate modules and global certification for both FDA requirements and ICH guidelines.
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