Senior Clinical Research Associate - Oncology - East Coast - Remote

Worldwide Clinical TrialsResearch Triangle Park, NC
Remote

About The Position

We are a global, midsize Contract Research Organization (CRO) that is committed to pushing boundaries and innovating to find cures for the world's most persistent diseases. We are Worldwide Clinical Trials, a global team of over 3,500+ experts dedicated to changing the way the world experiences CROs. Our mission is to work with passion and purpose every day to improve lives. We believe everyone plays an important role in making a world of difference for patients and their caregivers. We prioritize cultivating a diverse and inclusive environment that promotes collaboration and creativity, and we are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. As a Clinical Research Associate (CRA) within our Clinical Operations team, you will contribute to rewarding journeys that profoundly impact patients' lives. You will work alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases. Collaboration with top-tier colleagues is ingrained in our culture. We offer extensive support through regulatory submissions, TMF management, and in-house CRAs for projects with heavy site management needs. Regular touchpoints and coaching conversations with your Line Manager ensure your professional development is a top priority, with a clear career path that can lead to Clinical Trial Manager roles. Our accessible Executive Leadership team is committed to advancing science and overcoming obstacles to make a difference in patients' lives worldwide. Experience a world of difference with us at Worldwide!

Requirements

  • 5+ years of experience as a Clinical Research Associate
  • 4-year university degree OR Nursing Degree
  • Experience in Oncology is required
  • Candidates must reside on the East Coast, United States
  • Excellent interpersonal, oral, and written communication skills in English
  • Superior organizational skills with attention to detail
  • Ability to work with little or no supervision
  • Proficiency in Microsoft Office, CTMS, and EDC Systems

Responsibilities

  • Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs).
  • Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
  • Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects.
  • Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded.
  • Conduct study initiation visits (SIVs).
  • Ensure compliance with obtaining informed consent, reporting potential safety-related events, and adhering to all applicable regulatory requirements.

Benefits

  • We offer an unparalleled experience, where you can drive remarkable scientific breakthroughs and be at the very core of every successful clinical trial.
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