Sr. Study Coordinator

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US-Fixed Term Research & Clinical Remote, US

4 days ago Requisition

As a pharmaceutical support industry leader,
UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being:
Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

This is initially a 6 month Fixed Term Contract with the possibility of extending longer term

Responsible for supporting the conduct of clinical research from the setting of the UBC Study Coordinating Center (home based), ensuring the safety and well-being of participants while working closely with investigators, the sponsor and the research team to manage all aspects of the study, adhering to strict protocols and regulations.

• Supporting the screening process for potential participants including obtaining informed consent and acquiring medical records
• Schedule and conduct patient telehealth visits, performing study procedures as delegated by the PI and outlined in the protocol
• Collect, record, and maintain accurate clinical data in compliance with Good Clinical Practice (GCP) guidelines
• Manage investigational drugs logistics, from shipping through proper storage, accountability, and administration
• Coordinate the ‘end to end’ journey for the patient’s participation in the study including home health nursing visits, telehealth visits with the PI/Sub-I, visits to brick and mortar sites, shipment of study supplies and collection of samples, and use of technologies (ePRO/eCOA/devices).
• Prepare accurate and timely reports for the PI, Sub-I and Sponsor
• Training and mentorship for junior level study coordinators
• Monitor the study for adherence to the protocol and identify and address any deviations
• Maintain regulatory compliance by ensuring all required documentation is completed and up-to-date
• Handle inbound and outbound contacts from various sources (patients, healthcare providers, client, etc.) related to a specific UBC study
• Maintain a working knowledge of study guidelines, medication, or disease being referenced in call scripts, frequently asked questions, project specific procedures and study reference material
• Conduct communication through various channels (phone, fax, email) to retrieve data or to address discrepancies in data received
• Complete full follow-up with regards to missing information from stakeholders, including data entry process, as applicable, documentation, and safety reporting per study guidelines
• Ensure data entry, filing, and data confirmation are completed accurately and in a timely manner
• Apply corrections and/or updates to the secured study applications and/or appropriate documents that have been identified through data verification or follow up calls
• Document all communications in the appropriate application contact log in an accurate, concise, and timely manner
• Responsible for reporting any adverse events as appropriate
• Escalate potential problems or issues that require management’s immediate attention
• Responsible for ensuring all study compliance duties (including re-education of stakeholders,…