Logo of Huzzle

Clinical Trials Specialist (In-house CRA)

image

Actalent

9d ago

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

AI generated summary

  • You need 3+ years in clinical trials, 2+ years managing Trial Master File, supporting CTMs on CRO management, and taking meeting minutes.
  • You will support study leads by coordinating meetings, managing study documents, tracking site progress, and overseeing vendors while maintaining regulatory compliance and feasibility 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 coordinating meetings, preparing materials, and managing study documents.

What is the required experience for this position?

The position requires a minimum of 3+ years of clinical trials experience, along with 2+ years in managing the Trial Master File, supporting CTMs on CRO management, and experience in taking meeting minutes.

Is there any requirement for in-person work?

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

What types of studies will I be involved in?

You will be involved in both internally sourced studies and those outsourced to CROs.

Will I be responsible for managing any vendors?

Yes, your role may involve managing or overseeing Third Party Vendors.

Are there opportunities for growth and development within the company?

Yes, Actalent emphasizes growth opportunities for employees as part of its diversity, equity, and inclusion initiatives.

What support is available for those with disabilities during the application process?

Candidates may request reasonable accommodations for the application or interviewing process due to a disability by emailing actalentaccommodation@actalentservices.com.

Does Actalent have a commitment to diversity and inclusion?

Yes, Actalent is committed to diversity, equity, and inclusion, ensuring a supportive and inclusive environment for all employees.

What role do I play in the clinical trial documentation process?

You will contribute to the review of study documents such as informed consent forms and case report forms, and compile and maintain study manuals.

How does Actalent support its employees' well-being?

Actalent fosters a culture of care, engagement, and recognition, promoting an inclusive environment through persistent self-reflection and support initiatives for employee welfare.

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.