Senior Specialist, Regulatory & Site Activation - Argentina - RemoteApply remote type Remote locations Buenos Aires, Argentina time type Full time posted on Posted 2 Days Ago job requisition id JR100145
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 you will do Responsible for supporting end-to-end site start-up from site identification to site activation and maintenance serving as the primary point of contact for the site.Act as internal primary point of contact at country level for regulatory and site activation activities in the assigned studies.Responsible for customization of country specific patient information sheet, informed consent form, labels and local regulatory documents to comply with ICH GCP & country specific requirements.Review and provide advice on country timelines for the assigned studies.What you will bring to the role Strong organizational and management skills.Self-motivated learning about current regulatory processes and intelligence.Excellent written and verbal communication skills to clearly and concisely present information.Team-oriented work style; seeks and gives guidance to others.Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment.Excellent ability to handle multiple tasks in a fast-paced and changing environment.Your background A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science.Minimum one year of experience in clinical research, in regulatory-related function.Good knowledge of ICH GCP, EU Clinical Trials Directive and other relevant clinical research conduct guidance.Multilingualism preferred; fluent in local language; working knowledge of English.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.
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