Clinical Trial Coordinator - Client-dedicated (Warsaw)

Thermo Fisher Scientific•Poland, ME

11d•Onsite

About The Position

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. Who is PPD Clinical Research Services? PPD is a leading global contract research organization. Our purpose is to improve health. Our mission is to help customers deliver life-changing therapies. Our strategy is to bend the cost and time curve of drug development and optimize value for our customers. PPD is now part of Thermo Fisher Scientific. As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer. We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine The PPD FSP Solution: PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Extraordinarily trained, rigorously supported and technologically empowered to help customers lead capacity and set programs up for success. Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience. Clinical Trial Coordinator, client-dedicated Our team is expanding, and we are looking to recruit a CTC to be dedicated to one client only, using and working with their systems, SOPs and working only on client’s studies. You will provide technical support to the project team, coordinating non-clinical responsibilities of project administration as applicable to the client contract.

Requirements

University degree, or equivalent in education, training and experience
Responsible for adhering to Good Clinical Practices, country specific regulations, PPD/Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout
Experience with Submissions to Ethic Committees and Regulatory bodies
Ability to effectively analyse project specific data/systems to ensure accuracy and efficiency
Experience of manage multiple projects with differing priorities at one given time
Exceptional communication, collaboration, organisational and time management skills

Responsibilities

Performs PPD investigator file reviews and logging of outstanding issues in project related tracking tools
Reviews regulatory documents for proper content
Liaises with monitor and investigative sites to resolve outstanding regulatory issues identified
Disseminates study related information, including project tracking updates to Clients, clinical study teams and other PPD departments
Assists with the identification of potential investigators and development/distribution of initial protocol packets - Creates meeting agendas and minutes, as well as coordinates team conference calls and distribution of meeting minutes
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.
Supports the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans 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.
Supports scheduling of client and/or internal meetings.
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.
Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
Assists with study-specific translation materials and translation QC upon request.