Operations Associate, Clinical Assessment

hace 3 días

Ciudad de México CDMX Worldwide Clinical Trials A tiempo completo

**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**

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. (WCT). The Operations Associate is responsible for ensuring all assigned projects are conducted in a timely fashion and in a manner compliant with SOPs and ICH/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 logístical matters and prepare materials for Investigators’ Meetings, which 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 document

**What you will bring to the role**
- Highly organized, detail
- and service-oriented
- Meets timelines consistently and be able to effectively work under pressure
- 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

**Your experience**
- Preferred minimum of Associates degree
- At least 1+ years clinical trial experience
- Demonstrable knowledge of operational aspects 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 in order to attend key meetings. The global nature of the position may also require the incumbent to occasionally manage their time flexibly in order to be responsive to stakeholders in different time zones.

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

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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