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 Clinical Operations does at Worldwide
Embark on a fulfilling Clinical Operations career as you leave a lasting impact on patients’ lives. Join Worldwide Clinical Trials for an unparalleled CRO experience, where you can drive extraordinary scientific breakthroughs and contribute to the very heart of every successful clinical trial.
Working alongside brilliant minds across a variety of therapeutic areas, you will have the chance to collaborate closely with top-tier colleagues from diverse backgrounds and specialties. Our commitment to advancing clinical research is cultivated in a supportive, team-oriented atmosphere, with our hands-on leadership and dedicated team members working together to innovate and solve complex challenges for our customers.
What you will do
Process TMF documents for multiple studies both in an electronic and hard copy format
Assist the field CRA team in resolving TMF Quality Control Checklist queries, contacting site staff for outstanding documents, and processing documents for submission to the TMF
Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices
Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents
Communicate directly with Site Management Team members including CRAs, CTMs, to support with TMF related activities
Assist CRAs during and post close out with collecting documents to deliver TMF to sponsors
Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site
May perform tasks associated with in-house CRA I role such as:
Maintain regular communication with sites
Complete remote CRF review, using electronic data capture systems
Assist with ensuring site compliance with IP receipt, accountability and return or destruction, as applicable and appropriate
Provide other administrative support to Clinical Operations department, e.g. printing, scanning, and photocopying documents
What you will bring to the role
Excellent organizational skills, time management, written and oral communications, with timely follow up on tasks
Strong interpersonal skills in a fast-paced and rapidly changing environment
Possess data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions
Broad range of knowledge and advanced skills in the use of computer software including, but not limited to, word-processing, spreadsheets, electronic communications and graphics
Ability to prepare presentations in a clear, focused, and concise manner
Ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval
Basic knowledge of clinical research principles
Knowledge of standard operating procedures
Your experience
A minimum four-year college curriculum with a major concentration in a related area OR
Two-year college curriculum or equivalent education/training and one year relevant experience
High level of proficiency in both spoken and written English
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.