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Clinical Trials Specialist (In-house CRA)

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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 managing Trial Master Files, supporting CTMs in CRO management, and experience taking meeting minutes.
  • You will support clinical trials by coordinating meetings, preparing materials, managing study documents, tracking site activities, and overseeing vendors and initiatives.

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 job title for this position?

The job title is Clinical Trials Specialist (In-house CRA).

What are the primary responsibilities of the Clinical Trials Specialist?

The primary responsibilities include supporting Clinical Study Leads in global clinical trials, coordinating meetings, preparing materials, collating data for feasibility assessments, reviewing study documents, managing the eTMF, tracking site activation and enrollment, and overseeing Third Party Vendors.

What qualifications are required for this role?

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

Is this position full-time or part-time?

The job description does not specify, but it implies a full-time role as it supports various aspects of clinical trials.

What is the work schedule for the Clinical Trials Specialist?

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

Who is the employer for this job?

The employer is Actalent, a global leader in engineering and sciences services and talent solutions.

What is Actalent's stance on diversity and inclusion?

Actalent values diversity and inclusion as a bridge toward equity and success, and it embeds DE&I into its culture through hiring diverse talent, maintaining an inclusive environment, and ensuring growth opportunities for its people.

How can I request accommodation during the application process?

You can request a reasonable accommodation by emailing actalentaccommodation@actalentservices.com for other accommodation options.

Do I need prior experience in managing CROs for this role?

Yes, candidates should have at least 2+ years of experience supporting Clinical Trial Managers on CRO management.

Is there a focus on potential growth opportunities within the company?

Yes, Actalent emphasizes ensuring growth opportunities for their employees within a culture of care, engagement, and recognition.

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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.