Senior CRA I (with Italian and French Language)

Position Overview

• Location Type: Not Specified
• Job Type: Full-time
• Work Schedule: Standard (Mon-Fri)
• Environmental Conditions: Office
• Salary: Not Specified

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. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

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.

Ideal candidates will possess two or more years of onsite monitoring experience and have experience monitoring oncology. This position requires overnight travel either regionally or nationally, dependent on business needs.

Responsibilities

• 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 and/or monitoring environments (i.e. FSO, FSP, Government, etc.).
• 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.
• Ensures audit readiness.
• Develops collaborative relationships with investigational sites.
• 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.
• Assesses investigational product through physical inventory and records review.
• Documents observations in reports and letters in a timely manner using approved business writing standards.
• Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• 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.
• 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.
• 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, CTMS).
• Performs QC check of reports generated from CTMS system where required.
• Participates in investigator meetings as necessary.
• Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigational sites.

Requirements

• Two or more years of onsite monitoring experience.
• Experience monitoring oncology.

Company Information

At Thermo Fisher Scientific, we discover meaningful work that makes a positive impact on a global scale. Our Mission is to enable 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 PPD® clinical research services span laboratory, digital and decentralized clinical trial services, with clinical trials conducted in 100+ countries.