Descripción de la oferta
This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Environmental Conditions
Office
Join Us as a Sr/ Clinical Research Associate (Level I/II) – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. This opportunity is an exciting prospect for a big pharma company and for a new division focused on Oncology/Cell therapy.
As part of our global team, you'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., Acting as a site processes specialist, you will ensure 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. 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. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. May need to maintain 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. Conducts monitoring tasks in accordance with the approved monitoring plan. Ensures a shared responsibility with other project team members on issues/findings resolution. 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. Conducts on-site file reviews as per project specifications.
Clinical Trial Management System).
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
Contributes to other project work and initiatives for process improvement, as required.
Bachelor's degree in a life science related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Total experience: at least 2 years as a CRA
Oncology/Cell therapy experience: at least 2 years of on-site, hands-on experience
Valid driver's license where applicable.
Proven clinical monitoring skills
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving
Ability to manage Risk Based Monitoring concepts and processes
Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
Good English language and grammar skills
Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
May also include extended overnight stays.
