FSP Clinical Trial Coordinator II

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** Join Us as a Clinical Trial Coordinator II - Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you'll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Trial Coordinator II, you'll coordinate and facilitate project activities and may serve as a study lead, acting as a cross-functional liaison for the project team.

You will act as a buddy during the onboarding phase and provide training to new staff as needed. Additionally, you will support departmental and cross-functional initiatives for process improvements and enhancements.

What You'll Do

- According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix. - Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.

- Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.

- Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system.

Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system. - Provides system support (i. e. GoBalto & eTMF). - Supports RBM activities.

- 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, performing mass mailings and communications as needed, providing documents and reports to internal team members.

- Reviews and tracks local regulatory documents. - Transmits documents to client and centralized IRB/IEC. - Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. - Maintains vendor trackers. - May attend Kick off meeting.

Education and Experience Requirements: - High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. - Bachelor's degree preferred. - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).

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: - Ability to work in a team or independently as required - Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively - Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency - Strong customer focus - Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines - Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout - Excellent English language and grammar skills and proficient local language skills as needed - Good presentation skills - Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems - Ability to successfully complete PPD clinical training program - Self-motivated, positive attitude with effective strong interpersonal skills Working Conditions and Environment: - Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment.

- Occasional drives to site locations.

Potential Occasional travel required 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.