Thermo Fisher Scientific – Christchurch, South IslandFull timeAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.Our global Clinical Operations colleagues within our PPD clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.Location/Division Specific InformationThis home-based position requires candidates to currently be resident in New Zealand, located in Christchurch.Work ScheduleStandard (Mon-Fri)Job DescriptionPerforms and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability.A day in the Life:Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions.Maintains regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed.Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.May participate in investigator meetings as necessary.Ensures trial close out and retrieval of trial materials.Keys to Success:Education and Experience:Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.Monitoring experience in phase-I healthy volunteers studies is essential.Valid New Zealand driver's license is required.Knowledge, Skills and Abilities:Effective clinical monitoring skillsExcellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documentsStrong attention to detailPhysical Requirements / Work EnvironmentThis role requires independent travel up to 60%, inclusive of traveling in automobiles, airplanes, and trains.Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
#J-18808-Ljbffr