Coordinator, Safety Monitoring Committee (Mexico)

Requisition Number: 5919

Position Title: Coordinator, Safety Monitoring Committees

External 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 3,000 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.

What the Coordinator, Safety Monitoring Committees does at Worldwide

The Coordinator, Safety Monitoring Committees is a full-time position responsible for supporting activities as they pertain the operational aspects of the set-up and management of the Safety Monitoring Committees, inclusive of Data Safety Monitoring Boards (DSMB), Data Monitoring Committees (DMC), Safety Review Committees (SRC), Independent Review Committees (IRC) or Endpoint Adjudication Committees (EAC).

What you will do

• Support the Manager, Safety Monitoring Committee in operational set-up of committee meetings (Arrangement of the collection of CVs, financial disclosures, confidentially agreements for Committee members, Filing of documents in the Trial Master File), with the preparation of required meeting documentation and meeting materials
• Support Manager, Safety Monitoring Committee with preparation project specific plans and documentation, with contracting and payments of Committee members, as applicable
• Develop and maintain positive relationships both internal and external to projects, including Sponsors, team members, and committee members
• Ensures all required restricted access folders or portals are set up as per Committee Charter specification, initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects, support process improvement within department

What you will bring to the role

• Strong leadership and problem-solving skills, interpersonal skills in a fast-paced and rapidly changing environment
• Working knowledge of clinical research, ICH, GCP and FDA or EU directive regulations (as applicable)
• Excellent written and verbal communication skills; professional communication with internal and external counterparts
• Ability to manage escalations and resolve issues independently and the ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval
• Ability to handle multiple tasks, including rapid response in generating new documents, forms, and tools, strong organizational skills, especially around planning meetings
• Ability and willingness to work across multiple time zones

Your experience

• Two-year college curriculum or university degree In lieu of degree, relevant skills or equivalent experience in life sciences, biotech, or medical science
• At a minimum 1-2 years’ experience in clinical research
• Prior’ experience in project management and project management process preferable

• Prior experience in working with Safety Monitoring Committees preferable

Why Worldwide

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers. 

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!

 

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Employment Type: Regular

Community / Marketing Title: Coordinator, Safety Monitoring Committee (Mexico)

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Mexican Federal District, MX

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