Job Vacancy at Thermo Fisher Scientific
Thermo Fisher ScientificPOSITION: Sr CRA (Level II) At Thermo Fisher Scientific, you will discover important work that has a worldwide influence. Join our colleagues in realizing our mission: to enable our customers to create the world a better, cleaner, and safer place. We equip our people with the resources they need to pursue individual career objectives while pushing science forward via research, development, and the delivery of life-changing therapies.
Our work includes laboratory, digital, and decentralized clinical trial services, with clinical trials completed in over 100 countries and the continual development of novel frameworks for clinical research through our PPD clinical research portfolio. Your commitment to quality and accuracy will enhance the health outcomes on which people and communities rely now and in the future.
Summary of Purpose at Thermo Fisher Scientific:
All areas of clinical monitoring and site management are performed and coordinated. Manages relevant documents and conducts remote or on-site visits to assess procedures and regulatory compliance. Manages policies and rules from various sponsors and/or overseeing environments (for example, FSO, FSP, and government).
As a site processes specialist, you will ensure that the trial is carried out in compliance with the authorized protocol, ICH-GCP guidelines, applicable regulations, and SOPs to ensure subjects’ rights, well-being, and data dependability. Ascertains audit preparedness. Establishes collaborative partnerships with research sites. The task matrix outlines the detailed tasks and responsibilities assigned to each function.
- Monitors investigator sites using risk-based monitoring; uses critical thinking, problem-solving, and root cause analysis (RCA) to find process failures and take corrective or preventative actions to lower risks and get in line with the law.
- Monitoring data accuracy on-site and remotely with SDR, SDV, and CRF evaluation Physical inventory and record review serve to assess the investigational product.
- Document observations in timely reports and correspondence utilizing authorized corporate writing standards.
- Supervises work in accordance with the authorized monitoring strategy. Participates in the payment process for investigators.
- Ensures that issues and findings are resolved in collaboration with other project team members.
- Investigate and follow up on results as needed
- As needed, she attends investigator meetings. In partnership with the client company, identify suitable investigators to ensure the acceptability of qualified investigative sites.
- Through verbal, oral, and/or electronic contact, it facilitates effective communication between investigative sites, the client company, and the PPD project team.
- Responds to requirements, audits, and inspections from the company, the client, and any appropriate regulatory bodies.
- Maintains and completes administrative chores, including expenditure reports and timesheets, on time.
- Contributes to other project tasks and process improvement projects as needed. Success Factors
Qualifications and Experience:
- A bachelor’s degree in a life sciences-related discipline or a Registered Nursing certification or equivalent, as well as a corresponding formal academic or vocational qualification, are required.
- Previous experience that gives the necessary knowledge, skills, and abilities for the work (equivalent to 2+ years as a clinical research monitor)
Knowledge, abilities, and skills:
- Clinical monitoring abilities that are effective.
- Demonstrated knowledge of medical and therapeutic areas and medical terminology.
- Excellent knowledge and application of ICH GCPs, related regulations, and procedural papers.
- Critical thinking abilities include but are not limited to, critical mentality, in-depth inquiry for proper root cause analysis, and issue solving.
- Capability to manage concepts and processes related to risk-based monitoring.
- Effective oral and written communication abilities, as well as the ability to successfully communicate with medical personnel.
- Ability to keep clients focused through good listening skills, attention to detail, and perception of customers’ underlying difficulties.
- Interpersonal abilities that are effective.
- Excellent attention to detail.
- Excellent organizational and time management abilities.
- The ability to stay flexible and adaptable in a variety of situations
- Ability to operate as part of a team or individually as needed.
- Good digital literacy includes mastery of Microsoft Office and the capacity to learn new software.
- Excellent command of the English language and grammar.
- Excellent presentation abilities.
Benefits at Thermo Fisher Scientific:
We provide competitive pay, an annual incentive plan bonus, healthcare, and a variety of employee benefits. Thermo Fisher Scientific provides employment with an innovative, forward-thinking firm as well as excellent career and growth opportunities. We have a vibrant workplace culture that values integrity, passion, involvement, and creativity!
How to Apply for this Job Vacancy at Thermo Fisher Scientific:
Closing Date: 5th December 2023
For Jobs in Italy: