Operations Associate, Clinical Assessment Technologies - U.S. - Remote

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!

What the Operations Associate, Clinical Assessment Technologies does at Worldwide Clinical Trials

The Operations Associate has primary responsibility for carrying out all daily aspects of the operational work related to rater selection, rater certification/qualification, rater training content, scale acquisition, surveillance maintenance, workbook/source document, for Worldwide Clinical Trials, Inc. The Operations Associate is responsible for ensuring all assigned projects are conducted in a timely fashion and in a manner compliant with Standard Operating Procedure (SOP)s and International Council for Harmonisation (ICH)/Good Clinical Practice (GCP)/regulatory guidelines. The Operations Associate works under the direction of the Operations Manager, Clinical Assessment Technologies (CAT).

What you will do

• Track the collection, entry, and distribution of rater experience qualification data
  Review and may develop study-specific rater training web portal specifications for portal readiness

• Assist in coordinating logistical matters and prepare materials for Investigators’ Meetings, which the Associate may attend

• Edit/format materials such as for rater training, including Excel spreadsheets, PowerPoint training slides, and Microsoft Word

• Conduct scale management activities, such as obtaining scale licenses, translations, regulatory authorizations, and Sponsor approvals

• Track incoming source documentation to ensure timeliness of source reviews and provide data to the Sponsor and study team

• Communicate with research sites to ensure rater training and data surveillance plan guidelines are followed

• Provide CAT data for the CAT Final Study Report completion and ensure proper formatting of the document

• Other Clinical Assessment Responsibilities

• Assist the Operations Manager to ensure budgetary demands are met per the CAT project

• Conduct CAT study material archiving

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

What you will bring to the role

• Highly organized, detail- and service-oriented

• Meets timelines consistently and be able to effectively work under pressure

• Continuously open to constructive, developmental feedback

• Skilled in written and verbal communication in order to clearly and concisely present information

• High level of interpersonal skills in a fast-paced, deadline-oriented, and changing environment

• Able to manage multiple tasks and many administrative details in a fast-paced and constantly changing environment

• High level of self-motivation skills

• High-level ability to work in teams

• Excellent proficiency in all MS-Office applications, including Microsoft Word, Adobe, Excel, and PowerPoint

Your experience

• Preferred minimum of an associate’s degree

• Minimum 1+ year clinical trial experience

• Demonstrable knowledge of operational aspects of Phase I-IV clinical

• Ample knowledge of SOPs and ICH/GCP/regulatory guidelines

• Competency working with data and numbers

• Fluency in English (will be required to write, speak, and understand English to conduct day-to-day business)

• The role requires travel domestically and internationally to attend key meetings

• The global nature of the position may also require the incumbent to occasionally manage their time flexibly to be responsive to stakeholders in different time zones

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently

 

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.