Who We Are
Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. 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. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
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 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
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 www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
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.
