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Trial Administration Associate II

Remote: 
Full Remote
Contract: 
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

High school diploma or equivalent, Technical certification may be required, At least 2 years relevant experience, Knowledge of ICH Good Clinical Practices, Proficient in MS Office and clinical trial systems.

Key responsabilities:

  • Coordinate and oversee assigned trial activities
  • Perform file reviews and document findings
  • Ensure tasks are completed on time and within budget
  • Provide system support and maintain audit readiness
  • Support administrative tasks and manage project documentation
Thermo Fisher Scientific logo
Thermo Fisher Scientific Biotech: Biology + Technology Large https://www.thermofisher.com/
10001 Employees
HQ: Waltham
See more Thermo Fisher Scientific offers

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

  • 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. Escalates in cases of variances (overburn/underburn).
  • 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.
  • Provides system (i.e. CTMS, Oracle Activate & eTMF) support by managing the access requests, tracking study level documents, maintaining audit readiness and communicating the non-compliance to the study team.
  • Performs administrative tasks on assigned trials including, but not limited to: timely processing of documents sent to CRG's/Client eTMF as required, performing CRG's/Client eTMF reviews and coordinating for issue resolution, performing mass mailings and communications as needed, providing documents and reports to internal team members.
  • Supports scheduling and organization of client and/or internal meetings with completion and distribution of related meeting minutes.
  • Exports and reconciles study metrics reports. Maintains vendor trackers.
  • Proactively assists with coordination and compilation of Investigator Site File (ISF) template, pharmacy binder, with instruction from the Clinical Team Manager.
  • When required attends Kick off and Project Launch meetings and takes notes, supports initial study set-up.

Education and Experience:

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Technical positions may require a certificate

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).

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
  • Good time management skills. Flexibility to reprioritize workload to meet changing project timelines
  • Demonstrated ability to attain and maintain a good working knowledge of applicable Country

Regulations (if required), 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 (if required). Effective oral and written communication skills with the ability to communicate effectively with project team members
  • Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and learn the required clinical trial systems
  • Ability to successfully complete CRG training program
  • Self-motivated, positive attitude and good interpersonal skills

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Biotech: Biology + Technology
Spoken language(s):
EnglishEnglish
Check out the description to know which languages are mandatory.

Other Skills

  • Microsoft Office
  • Time Management
  • Physical Flexibility
  • Verbal Communication Skills
  • Self-Motivation
  • Organizational Skills
  • Teamwork
  • Detail Oriented
  • Social Skills

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