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Trial Administration Associate II

AT Thermo Fisher Scientific
Thermo Fisher Scientific

Trial Administration Associate II

Remote

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

  • 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.

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  • 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

Job ID: ThermoFisher-R-01254915-5
Employment Type: Full Time

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • FSA
    • HSA
    • HSA With Employer Contribution
    • Mental Health Benefits
    • Fitness Subsidies
  • Parental Benefits

    • Adoption Leave
    • Birth Parent or Maternity Leave
    • Non-Birth Parent or Paternity Leave
    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
  • Work Flexibility

    • Flexible Work Hours
    • Hybrid Work Opportunities
    • Remote Work Opportunities
  • Office Life and Perks

    • Commuter Benefits Program
    • On-Site Cafeteria
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Volunteer Time Off
  • Financial and Retirement

    • 401(K) With Company Matching
    • Stock Purchase Program
    • Financial Counseling
    • Performance Bonus
  • Professional Development

    • Tuition Reimbursement
    • Access to Online Courses
    • Internship Program
    • Mentor Program
  • Diversity and Inclusion

    • Employee Resource Groups (ERG)
    • Diversity, Equity, and Inclusion Program