Clinical Trial Coordinator

Employment Type: Full-time Work Schedule: Other Environmental Conditions: Office

Position Overview

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.

Discover Impactful Work

As a Clinical Trial Coordinator, you will provide administrative and technical support to studies and study teams. You will support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. You will aid the development of the critical path for site activation within assigned projects in support of rapid site activations.

A Day in the Life

• Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
• Ensures allocated tasks are performed on time, within budget and to a high-quality standard.
• Proactively communicates any risks to project leads.
• Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
• Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
• May support scheduling of client and/or internal meetings.
• May review and track of local regulatory documents.
• Maintains vendor trackers.
• Supports start-up team in Regulatory submissions.
• Works directly with sites to obtain documents related to site selection.
• Works in collaboration with teammates to achieve targeted goals for assigned projects.
• Connect with the team and appropriate clinical personnel regarding site issues and risks.

Keys to Success

Education

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
• Bachelor's degree preferred.

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
• 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, Abilities

• Ability to work in a team or independently as required.
• Flexibility to reprioritize workload to meet changing project timelines.
• Demonstrated ability to attain and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.
• Good English language and grammar skills and proficient local language skills as needed.
• Good digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems.
• Effective oral and written communication skills.
• Crucial judgment and decision-making skills.
• Capable of accurately following project work instructions.

Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)

Benefits

We offer competitive remun