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Clinical Trials Specialist (In-house CRA)

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Actalent

Today

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

AI generated summary

  • You need 3+ years in clinical trials, 2+ years managing Trial Master Files, supporting CTMs with CROs, and taking meeting minutes.
  • You will support clinical trials by coordinating meetings, preparing documents, assessing sites, managing study manuals, tracking enrollment, and overseeing vendors.

Requirements

  • 3+ years of clinical trials experience
  • 2+ years of managing Trial Master File
  • 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 primary responsibility of a Clinical Trials Specialist?

The primary responsibility of a Clinical Trials Specialist is to support Clinical Study Leads in the execution of global clinical trials, coordinating meetings, preparing study-related materials, and managing data related to feasibility and site selection assessments.

How many years of clinical trials experience are required for this position?

A minimum of 3 years of clinical trials experience is required for this position.

Is experience with the Trial Master File (TMF) necessary for this role?

Yes, 2 years of experience managing the Trial Master File is required for this role.

Will I be required to take meeting minutes in this position?

Yes, taking meeting minutes is part of the job, and at least 2 years of experience in this area is required.

What type of work schedule can I expect in this role?

This is a hybrid position, requiring some days on-site and some days remote.

Is there an opportunity for diversity and inclusion within the company?

Yes, diversity and inclusion are foundational to Actalent's culture, with efforts to hire diverse talent and maintain an inclusive environment.

Does Actalent support accommodations for individuals with disabilities during the application process?

Yes, Actalent provides reasonable accommodations for applicants with disabilities and encourages them to request modifications or adjustments as needed.

Will I be managing any third-party vendors in this role?

Yes, the role may involve managing or overseeing third-party vendors.

What departments or initiatives might I participate in as a Clinical Trials Specialist?

You may participate in Standard Operating Procedure (SOP) revisions and departmental initiatives as part of your responsibilities.

Is Actalent an equal opportunity employer?

Yes, Actalent is an equal opportunity employer and considers all applications without regard to protected characteristics.

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.