PPD Latin America – Christchurch, South Island
At 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 Information
This home-based position requires candidates to currently be resident in New Zealand, located in Christchurch.
Job Description
Performs 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. Manages procedures and guidelines from different sponsors. 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 to bring the site into compliance and decrease risks.
Maintains regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations.
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 and ability to drive.
Knowledge, Skills and Abilities:
Effective clinical monitoring skills
Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
Effective oral and written communication skills
Physical Requirements / Work Environment
Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.
Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits.
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Apply today!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer.
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