[Hiring] Clinical Research Associate I @Thermo Fisher Scientific

Role Description

Join Us as a Clinical Research Associate I – Make an Impact at the Forefront of Innovation. As part of our global team, you'll have the opportunity to perform and coordinate different aspects of the clinical monitoring and site management process.

• Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.
• Manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.).
• Ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
• Ensure audit readiness and develop collaborative relationships with investigational sites.
• Monitor investigator sites with a risk-based monitoring approach.
• Apply root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and corrective/preventive actions.
• 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.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process.
• Ensure shared responsibility with other project team members on issues/findings 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.
• Initiate clinical trial sites according to relevant procedures to ensure compliance.
• Perform trial close out and retrieval of trial materials.
• Ensure that 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 are complete, accurate, and updated per agreed study conventions.
• Facilitate effective communication between investigative sites, the client company, and internal project teams.
• Respond to company, client, and applicable regulatory requirements/audits/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/suggestions.
• Contribute to other project work and initiatives for process improvement, as required.

Qualifications

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent.
• Minimal clinical monitoring experience (comparable to 1-2 years) in a clinical environment.
• Experience in clinical trials, medical terminology, medical research, clinical research, or health care.
• Equivalency of education, training, and/or directly related experience may be considered.

Requirements

• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations.
• Good oral and written communication skills.
• Good interpersonal skills.
• Ability to maintain customer focus through good listening skills and attention to detail.
• Good organizational and time management skills.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Well-developed critical thinking skills.
• 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.
• Good English language and grammar skills.

Benefits

• Frequent travel to site locations (generally 60-80%).
• Work is performed in an office, clinical trial site, and/or home office environment.