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Clinical Trials Specialist In House CRA In Office

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Actalent

3mo ago

  • Job
    Full-time
    Mid Level
  • Research & Development
    Healthcare

AI generated summary

  • You need 3+ years in clinical trials (2+ years in Pharma preferred), 2+ years managing TMF (Veeva Vault), supporting CTMs with CROs, and experience taking meeting minutes.
  • You will support clinical trial execution, coordinate meetings, manage study documents, track site activation/enrollment, and oversee vendor relationships.

Requirements

  • 3+ years of clinical trials experience (2+ years Pharma experience preferred) - will take from site level (needs 3-4+ years at site)
  • 2+ years of managing Trial Master File (Veeva Vault)
  • 2+ years of experience supporting CTMs on CRO management
  • 2+ years of experience taking meeting minutes

Responsibilities

  • As a Clinical Trials Specialist, you will support Clinical Study Leads in the execution of global clinical trials, including both internally sourced studies and those outsourced to CROs.
  • You will schedule and coordinate meetings, prepare agendas, presentation materials, and minutes for clinical study team meetings and other study-related gatherings.
  • You will collate data for feasibility and site selection assessments, review site usability databases, and contribute to the review of study documents such as informed consent forms and case report forms.
  • Additionally, you will compile and maintain study manuals, manage the eTMF, track site activation and enrollment, monitor investigator/site status, and support clinical trial registry postings.
  • Your role may also involve managing or overseeing Third Party Vendors and participating in SOP revisions or departmental initiatives.

FAQs

What is the job title for this position?

The job title for this position is Clinical Trials Specialist.

What are the main responsibilities of a Clinical Trials Specialist?

The main responsibilities include supporting Clinical Study Leads in global clinical trials, scheduling and coordinating meetings, preparing agendas and presentation materials, collating data for feasibility and site selection assessments, managing the eTMF, tracking site activation and enrollment, and supporting clinical trial registry postings.

Is this a full-time position?

No, this is a contract position with a duration of 12 months.

Where is this position located?

This position is hybrid, requiring some days to be on-site in Basking Ridge, New Jersey, or Armonk, New York, and some days remote.

What is the required experience for this role?

The role requires 3+ years of clinical trials experience, with at least 2+ years of Pharma experience preferred, as well as 2+ years managing the Trial Master File (Veeva Vault) and supporting CTMs on CRO management.

What is the dress code for the office environment?

The dress code for the office environment is business casual.

Does Actalent have a diversity and inclusion policy?

Yes, Actalent emphasizes diversity, equity, and inclusion as a core part of their culture, focusing on hiring diverse talent, maintaining an inclusive environment, and ensuring growth opportunities for all employees.

Are there any specific skills required for this position?

Yes, some specific skills include experience in managing Trial Master Files, supporting Clinical Trial Managers, taking meeting minutes, and familiarity with study-related documentation.

How can I request accommodations during the application process?

If you need to request a reasonable accommodation due to a disability, please email actalentaccommodation@actalentservices.com for assistance.

What type of projects will I be involved in as a Clinical Trials Specialist?

You will be involved in executing global clinical trials, including both internally sourced studies and those outsourced to CROs, and managing various aspects of clinical trial documentation and site management.

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Actalent

An Engineering and Sciences Services Company | People to Possible

Human Resources
Industry
5001-10,000
Employees

Mission & Purpose

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent’s global footprint and flexible delivery models ensure access to specialized talent where and when you need it. We promote consultant engagement through professional development and provide experiences to ensure continuous learning. Our people are the difference. Our expertise spans capabilities in engineering including product and manufacturing, systems and software, construction management, environmental, architecture and civil; and power and utilities. We focus on sciences capabilities in laboratory sciences, healthcare, and clinical research. Actalent is an operating company of Allegis Group, the global leader in talent solutions.