Work Schedule Environmental Conditions Job Description At PPD (CRG), part of Thermo Fisher Scientific, you can have a relevant impact on a global scale. Join our team in bringing our Mission to life and helping our customers make the world healthier, cleaner, and safer. We support individual career goals and contribute to life-changing therapies through research, development, and delivery. Our work includes clinical trials conducted in 100+ countries and innovative frameworks for clinical research. Your dedication to quality and accuracy will positively impact health outcomes for people and communities. A day in a life: Monitors investigator sites using a risk-based approach, identifying site process failures and taking corrective/preventive actions to ensure compliance and reduce risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assesses investigational product through physical inventory and records review. Documents observations in reports and letters according to timelines using approved business writing standards. Advances any observed deficiencies or issues to clinical management promptly and ensures their resolution. May also need to stay in touch with investigative sites between visits to ensure protocol compliance and timely data recording. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System). Support the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Assist to other project work and initiatives for process improvement, as required. Education and Experience: University degree or equivalent experience in a science related field Understanding of ICH-GCP, EU and FDA requirements Proficient in English and Fluent in Thai Knowledge, Skills and Abilities: Proven clinical monitoring skills Strong understanding of medical/therapeutic area knowledge and medical terminology Ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents Well-developed critical thinking skills, including but not limited to: a thoughtful approach, detailed investigation for appropriate root cause analysis, and problem-solving mentality. Ability to run Risk Based Monitoring concepts and processes Good oral and written communication skills, with the ability to communicate optimally with medical personnel Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues Good organizational and time management skills Effective social and attention to detail skills Ability to remain flexible and adaptable in a wide range of scenarios Ability to work in a team or independently as required
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