Clinical Trial Coordinator (CTC) at THERMO FISHER BIOPHARMA SERVICES PTE LTD

Taipei, , Taiwan -

Full Time

Start Date

Immediate

Expiry Date

06 Oct, 26

Salary

0.0

Posted On

08 Jul, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Coordination, eTMF, Site Activation, Regulatory Compliance, ICH GCP, Project Management, Data Analysis, MS Office, Site Feasibility, Audit Readiness, Communication Skills, Organization Skills

Industry

Biotechnology Research

Description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Trial Coordinator – 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 Coord, you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations. Representing CRG personnel, you may utilize local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. Additionally, you may act as a buddy during the onboarding phase and provide training to new staff as needed. What You’ll Do: • According to the specific role, coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix. • 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. • Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. • 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. • Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided. • Where applicable, conducts on-site feasibility visits (Asia Pac only). • May support scheduling of client and/or internal meetings. • May review and track of local regulatory documents. • May provide system support (i.e., Activate & eTMF). May support RBM activities. • May support 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(s). • Transmits documents to client and centralized IRB/IEC. • Maintains vendor trackers. • Supports start-up team in Regulatory submissions. • Works directly with sites to obtain documents related to site selection. • Assists the project team with the preparation of regulatory compliance review packages. • Provides support as needed to coordinate with internal departments, ensuring site start-up activities within the site activation critical path are aligned. • May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel. • Documents in real time all communication, attempts an follow up associated with site contact and survey responses. • Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked. • Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks. • Ensures an efficient, effective plan is in place for site contact and follow up. Ensure compliance with the plan and escalate concerns/non-compliance to management. • May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harness this knowledge base when performing local tiering of sites. • Liaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information. • Contributes to the development and roll-out of global strategic feasibility processes and best practices. • Trains new personnel in processes and systems. • Utilizes local knowledge to contribute to the identification and development of new sites. 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 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 and Abilities: • Ability to work in a team or independently as required • Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively • Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency • Strong customer focus • Flexibility to reprioritize workload 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 • Good English language and grammar skills and proficient local language skills as needed • Good 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 the organizations clinical training program • Self-motivated, positive attitude and good interpersonal skills • Effective oral and written communication skills • Good interpersonal skills • Essential judgment and decision-making skills • Capable of accurately following project work instructions • Good negotiation skills • Independent thinker • Ability to manage risk and perform risk escalation appropriately 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. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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Responsibilities

Provide administrative and technical support to project teams to ensure audit readiness and efficient site activation for clinical trials. Coordinate trial activities, manage study metrics, and maintain essential regulatory documentation and system databases.