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Clinical Trials Associate

Role overview

Qualifications

  • Degree level qualification or equivalent experience with a minimum of one year in a related role
  • Proficiency in MS Office applications (Outlook, Word, Excel, PowerPoint) and strong document management
  • Excellent written and verbal English; fluency in the local language of the country of location
  • Knowledge and understanding of ICH, GCP, and FDA or EU directive regulations as applicable

Responsibilities

  • Arrange and track system access for the project team (Project Managers, Lead CRAs, CRAs, etc.)
  • Maintain and quality audit to ensure the most recent revisions of documents are on project portals and submit to the trial master file
  • Assist project team with preparation and shipment of clinical trial documentation, including Investigator Site File; maintain version control of project documentation
  • Generate and distribute minutes for project-related meetings (Sponsor and Internal Management) and maintain site and personnel information; arrange project-specific training

Key facts

Other skills

  • Microsoft Office
  • Social Skills
  • Communication
  • Teamwork
  • Adaptability
  • Multitasking
  • Decision Making
  • Detail Oriented
  • Organizational Skills
  • Problem Solving

About the company

Worldwide Clinical Trials logo

Worldwide Clinical Trials

Research

About Worldwide Clinical Trials  Worldwide Clinical Trials is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new treatments. Our capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by our team members who bring their expertise and a collaborative, personalized approach to each clinical program. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers. Our talented team of 3,000+ professionals spans 60+ countries, and embraces a culture of diversity, equity, inclusion, and belonging (DEI&B). We are united in cause with our customers to improve the lives of patients through new, innovative therapies. For more information on Worldwide, visit www.Worldwide.com.

Company details

Company typeLarge
IndustryResearch
Company size1001 - 5000

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Job description

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

The Clinical Trials Associate is responsible for providing administrative and project tracking support to the clinical project team, ensuring tasks for all assigned projects with Project Delivery services are performed timely and accurately.


RESPONSIBILITIES:
Tasks may include but are not limited to:

  • Arrange and track system access for project team (Project Managers, Lead CRAs, CRAs, etc.)
  • Maintain and quality audit to assure the most recent revisions of documents are on project portals
  • Assist project team with preparation and shipment of clinical trial documentation, including Investigator Site File
  • Maintain version and quality control of project documentation and submit to trial master file
  • Assist with the tracking and maintenance of project related information, including site medical question and answer log
  • Generate and distribute minutes for a range of project related meetings, including Sponsor and Internal Management
  • Maintain current participating site and personnel information
  • Arrange and track the distribution of project specific training to the project team
  • Perform other duties as assigned


The responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

SKILLS AND ABILITIES:

  • Excellent written and verbal English as well as fluency of the language of the country of location
  • Strong interpersonal skills
  • Ability to work independently and as a team member
  • Sense of urgency and ability to be adaptable in a fast-paced and rapidly changing environment
  • Ability to handle multiple tasks and exercise independent judgment
  • Strong attention to detail and focus on quality of work
  • Strong organizational and problem-solving skills
  • Excellent skills in MS Office applications including Outlook, Word, Excel and PowerPoint
  • Knowledge and understanding of ICH, GCP, and FDA or EU directive regulations (as applicable)


REQUIREMENTS:

  • Degree level qualification or equivalent experience plus a minimum of one years’ experience in a related role
  • Skill sets and proven performance equivalent to the above

We love knowing that someone is going to have a better life because of the work we do. 

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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