Job Description: Clinical Research Associate II - Report Review

Employment Type: Full time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office

Position Overview

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.

A Day in the Life

• Performs centralized report review and approval of PSV, SIV, IMV and COV reports on assigned project(s) in accordance with procedural documents and guidelines.
• Provides training to new CRMs, and may act as Lead report reviewer on allocated project(s) acting as central liaison between CRM team and CTM/PM.
• This job is a fully qualified, career-oriented, journey-level position.

Essential Functions

• Performs review of clinical monitoring visit reports for allocated projects ensuring consistency across protocols and/or regions.
• Escalates any protocol, site, and/or CRA issues or trends noted during the report review process to CTM.
• Liaises with clinical monitoring staff for prompt trip report review submission and approval as per the stipulated timelines of PPD and/or the Sponsor.
• Plays an active role on the project team to help ensure compliance with monitoring visit report expectations.
• Reviews and customizes the Monitoring Report Templates for allocated projects.
• Evaluates PI oversight (e.g., protocol adherence), subject safety, and study processes to assess site’s ability to conduct study, as ascertained from information noted in monitoring visit reports and associated electronic data systems.
• Attends applicable internal Project meetings.
• Provides input of forecast estimates for report review activities.
• Provides trial MVR status tracking and progress update reports to CTM/CRA as the need arises.
• Contributes to company, client, and federal/local regulatory requirements/audit responses as needed.
• Provides training and mentoring to new CRMs.
• May act as lead report reviewer on allocated projects acting as key liaison between teams.
• May perform support activities to the team as agreed on allocated projects.

Business Relationships

• Represents the department as a prime contact on projects.
• Interacts with internal and external personnel on significant matters, often requiring coordination between functional areas.
• Networks with senior internal and external personnel in own area.

Required Education and Experience

• Bachelor’s Degree in a science-related field or relevant/equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.
• Prior clinical research experience with a minimum of 4 years on-site clinical monitoring or minimum 5+ years report review experience.
• In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities

• Excellent therapeutic area knowledge and understanding of medical terminology by virtue of past training of a CRA and prior visit report reviewer experience.
• Ability to attain and maintain a working knowledge of FDA and/or local country regulations and guidelines, ICH GCPs, and PPD procedural documents.
• Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP).
• Highly effective oral and written communication skills.