Clinical Trial Coordinator

hace 4 semanas

Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

Job Summary


We are seeking a highly skilled Clinical Trial Coordinator to support our clinical trials team. This role will be responsible for coordinating, overseeing, and completing functions on assigned trial activities as detailed on the task matrix.


Key Responsibilities



  • Task Matrix Execution: Coordinate, oversee, and complete functions on assigned trial activities as detailed on the task matrix.
  • Department, Internal, Country, and Investigator File Reviews: Perform department, internal, country, and investigator file reviews as assigned, and document findings in appropriate systems.
  • Task Management: Ensure allocated tasks are performed on time, within budget, and to a high-quality standard. Proactively communicate any risks to project leads.
  • System Support: Provide system support (Activate & eTMF) and ensure system databases are always current.
  • Administrative Tasks: Perform 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.
  • Site Support: Assist with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
  • Translation Support: Assist with study-specific translation materials and translation QC upon request.
  • Regulatory Support: Maintain knowledge of and understand SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
  • Travel and Meetings: Where applicable, conduct on-site feasibility visits (Asia Pac only). May support scheduling of client and/or internal meetings.
  • Documentation and Tracking: Maintain vendor trackers. Supports start-up team in Regulatory submissions.
  • Communication and Collaboration: Work directly with sites to obtain documents related to site selection. Assist the project team with the preparation of regulatory compliance review packages.
  • Site Management: Provide support as needed to coordinate with internal departments, ensuring site start-up activities within the site activation critical path are aligned.
  • Survey and Data Management: Document in real-time all communication, attempts, and follow-up associated with site contact and survey responses.
  • Teamwork and Collaboration: Work in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
  • Knowledge Sharing and Development: Contribute to the development and roll-out of global strategic feasibility processes and best practices.
  • Training and Development: Train new personnel in processes and systems.
  • Site Identification and Development: Utilize local knowledge to contribute to the identification and development of new sites.

Working Conditions and Environment:



  • Work is performed in an office/laboratory/clinical/Home Office environment with exposure to electrical office equipment.
  • Occasional drives to site locations. Potential occasional travel required.

Requirements:



  • 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 organization's 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.

Preferred Qualifications:



  • Bachelor's degree preferred.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
  • High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification.

Working Conditions:



  • Work is performed in an office/laboratory/clinical/Home Office environment with exposure to electrical office equipment.
  • Occasional drives to site locations. Potential occasional travel required.

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