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Clinical Trials Specialist (In-house CRA)

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Actalent

4d ago

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

AI generated summary

  • You need 3+ years in clinical trials, 2+ years managing Trial Master Files, supporting CTMs on CRO management, and taking meeting minutes.
  • You will support clinical study leads by coordinating meetings, preparing materials, managing eTMF, tracking site status, and overseeing vendors while assisting with study documentation and assessments.

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 role of a Clinical Trials Specialist?

The primary role of a Clinical Trials Specialist is to support Clinical Study Leads in the execution of global clinical trials, including scheduling and coordinating meetings, preparing study-related documents, managing the eTMF, tracking site activation and enrollment, and overseeing vendor management.

What qualifications are required for this position?

Candidates should have 3+ years of clinical trials experience, 2+ years of managing the Trial Master File, experience supporting CTMs on CRO management, and experience taking meeting minutes.

Is this position fully remote?

No, this is a hybrid position requiring some days on-site and some days remote.

What type of environment does Actalent promote regarding diversity and inclusion?

Actalent promotes a diverse and inclusive environment by hiring diverse talent, maintaining inclusion through self-reflection, building a culture of care and recognition, and ensuring growth opportunities for all employees.

What should I do if I need an accommodation during the application process?

If you need a reasonable accommodation due to a disability, you should email actalentaccommodation@actalentservices.com for other accommodation options.

Will I be involved in reviewing study documents?

Yes, as a Clinical Trials Specialist, you will contribute to the review of study documents such as informed consent forms and case report forms.

Are there opportunities for growth within the company?

Yes, Actalent is committed to ensuring growth opportunities for all employees as part of its culture of care and engagement.

Is Actalent an equal opportunity employer?

Yes, Actalent is an equal opportunity employer and considers all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.

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.