FSP Clinical Research Associate I/ Clinical Research Associate II

Overview

Clinical Research Associate role within Thermo Fisher Scientific's global team, performing and coordinating clinical monitoring and site management activities across investigator sites.

What you'll do

• Monitor investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking and problem-solving to identify site process failures and corrective/preventive actions to bring sites into compliance and decrease risks.
• Ensure 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.
• Document observations in reports and letters in a timely manner using approved business writing standards.
• Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• Maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence, resolution of previously identified issues, and timely data recording, as needed.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process.
• Share responsibility with other project team members for issue and finding resolution.
• Investigate and follow up on findings as applicable.
• Participate in investigator meetings as necessary.
• Help identify potential investigators in collaboration with the client company to ensure acceptability of qualified investigative sites.
• Initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
• Perform trial close-out and retrieval of trial materials.
• Ensure required essential documents are complete and in place according to ICH-GCP and applicable regulations.
• Conduct on-site file reviews as per project specifications.
• Provide trial status tracking and progress update reports to the team as required.
• Ensure study systems (e.g. Clinical Trial Management System) are complete, accurate and updated per agreed study conventions.
• Facilitate effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts.
• Respond to company, client and applicable regulatory requirements, audits and inspections.
• Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner.
• Contribute to the project team by assisting in preparation of project publications/tools and sharing ideas with team members.
• Contribute to other project work and process improvement initiatives as required.

What you'll need

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
• 1-2 years of experience as a Clinical Research Associate / Monitor.
• Valid driver's license where applicable.
• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents.
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Good interpersonal skills.
• Ability to maintain customer focus through good listening skills, attention to detail and the ability to perceive customers' underlying issues.
• Good organizational and time management skills.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Well-developed critical thinking skills, including critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Ability to manage Risk Based Monitoring concepts and processes.
• Ability to work in a team or independently as required.
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software.
• Good English language and grammar skills.

Details

• Location: Remote, Israel.
• Work schedule: Standard (Mon-Fri).
• Frequent travel, generally 60-80% but more for some individuals, including frequent drives to site locations and possible extended overnight stays.
• Work performed in an office, laboratory, clinical and/or home office environment with exposure to electrical office equipment.
• Exposure to biological fluids with potential exposure to infectious organisms; personal protective equipment required (protective eyewear, garments and gloves).
• Exposure to fluctuating and/or extreme temperatures on rare occasions.