Clinical Trial Coordinator

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Work ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionOur 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 WorkAs 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 LifePerforms 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 SuccessEducationHigh / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. Bachelor's degree preferred. ExperiencePrevious 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, AbilitiesAbility to work in a team or independently as requiredFlexibility to reprioritize workload to meet changing project timelinesDemonstrated ability to attain and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDsGood English language and grammar skills and proficient local language skills as neededGood digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systemsEffective oral and written communication skillsCrucial judgment and decision-making skillsCapable of accurately following project work instructionsWork EnvironmentRequirementsThermo 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.

)BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. If you have questions about this posting, please contact support@lensa. com