Senior Clinical Research Associate - CNS/Early Phase - Australia - Remote

 Posted 2 hours ago
     
5-10 years experience
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AI Summary

Responsible for the full lifecycle of site management, including qualification, initiation, monitoring, and close-out visits. The role involves ensuring protocol adherence, verifying source documents, and mentoring less experienced CRAs.

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 Department does at Worldwide 

Clinical Research Associates (CRAs) play a vital role in ensuring our clinical research programs are executed with the quality and excellence our sponsors expect and the care and passion patients deserve. 

These roles are the backbone of every strong CRO, helping drive breakthrough scientific research and playing a lead role on every clinical trial. All CROs will promise you growth, opportunity and maybe even a challenge. But we offer more than that. We offer an uncommon experience – one you can’t get anywhere else, with a team unlike anyone else. 

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 trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you daily - committed to advancing science and moving mountains for our customers. 

What you will do 

  • Responsible for site qualification, initiation, interim monitoring, site management, and study close-out visits. 

  • Provide mentoring and guidance to less experienced CRAs and site staff when needed. 

  • Document site visit findings via written reports. 

  • Assess, monitor, and train study site staff on protocol adherence as required. 

  • Review study subject safety information and informed consent. 

  • Conduct source document verification for compliance, patient safety, and veracity of data. 

  • Review CRFs using paper or electronic data capture systems and assist sites with data query resolution. 

  • Provide applicable updates for site related documentation for filing in the Trial Master File (TMF). 

  • Ensure site compliance with IP receipt, accountability and return or destruction. 

  • Conduct accompanied site visits for assessment or training of other CRAs as requested and appropriate. 

What you will bring to the role 

  • Excellent interpersonal, oral, and written communication skills in English. 

  • Superior organizational skills with attention to details. 

  • Ability to work with little or no supervision. 

  • Proficiency in Microsoft Office, CTMS and EDC Systems. 

Your experience 

  • 5+ years of experience as a Clinical Research Associate. 

  • 4-year university degree or RN/BSN in Nursing. 

  • Experience with CNS and Early Phase/Healthy Volunteer studies is required for this role.

  • Willingness to travel required. 

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.

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