Clinical Trial Coordinator I

Work Schedule

Environmental Conditions

Job Description

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.

Education and Experience:

Responsibilities:

• Bachelor's degree in Life Sciences or related field
• Minimum 1-2 years of experience in clinical research or related field
• Strong knowledge of relevant regulations and guidelines
• Excellent organizational and time management skills
• Exceptional attention to details

• Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned
• Completes and documents study-specific training.
• Orients and trains on any CRG/study-specific systems.
• Provides in-house support during pre-study assessments and with pre-study as agreed for project.
• Coordinates and supports logistics for IM attendance, as directed.
• Supports Essential Document collection, review and updating in systems, as
  applicable.
• Collaborate with cross-functional teams to ensure efficient delivery of projects
• Verifies document collection status in CRG systems and drives action for missing/incomplete/expired documents and open document findings, as directed
• Complete projects within strict timelines and budgets
• May perform other assigned tasks, as per Task Matrix
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

Knowledge, Skills and Abilities:

• Demonstrated ability to attain and maintain a solid understanding of ICH GCPs, applicable regulations and procedural documents.
• Well-developed critical thinking skills, including but not limited to: critical mindset,
• Good oral and written communication skills
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues.
• Good organizational and time management skills
• Effective interpersonal skills.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Ability to work in a team or independently as required.