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Clinical Trials Specialist (In-house CRA)

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Actalent

3d ago

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

AI generated summary

  • You need 3+ years in clinical trials, 2+ years managing Trial Master Files, supporting CTMs with CRO management, and taking meeting minutes.
  • You will support clinical study leads by coordinating meetings, preparing materials, reviewing documents, managing eTMF, tracking site status, and overseeing third-party 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 qualifications are required for the Clinical Trials Specialist position?

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

What will my responsibilities be in this role?

As a Clinical Trials Specialist, you will support Clinical Study Leads in executing global clinical trials, schedule and coordinate meetings, prepare agendas and minutes, compile data for feasibility assessments, manage study documents, oversee Third Party Vendors, and support clinical trial registry postings.

Is this position fully remote?

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

What is the company’s stance on Diversity, Equity, and Inclusion?

Actalent values diversity and inclusion, embedding DE&I into their culture through diverse hiring, maintaining an inclusive environment, promoting a culture of care and engagement, and ensuring growth opportunities for all employees.

Are there opportunities for professional growth in this position?

Yes, Actalent provides growth opportunities for their employees as part of their commitment to diversity, equity, and inclusion.

How do I request accommodations during the application process?

You can request reasonable accommodations, such as adjustments to the job application or interview process due to a disability, by emailing actalentaccommodation@actalentservices.com.

Does Actalent offer equal employment opportunities?

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.