Senior Study Coordinator

🔥 0 minutes ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟠 Senior

👻 Ghost score 10%

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UBC

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

UBC is a company dedicated to improving patient outcomes by connecting specialty therapies to patients in need. They provide modern and customized solutions focusing on access, safety, and evidence generation for biopharmaceutical products. UBC specializes in evidence development, risk management, and patient access, utilizing real-world data and innovative technologies to optimize the healthcare journey and ensure effective medication use.

📋 Description

• Support the conduct of clinical research from the home-based UBC Study Coordinating Center • Support screening potential participants, obtain informed consent, and acquire medical records • Schedule and conduct patient telehealth visits and perform study procedures 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 drug logistics, including shipping, storage, accountability, and administration • Coordinate the end-to-end patient participation journey, including home health nursing visits, telehealth visits, brick-and-mortar site visits, study supply shipments, sample collection, and ePRO/eCOA/device technologies • Prepare reports for the PI, Sub-I, and Sponsor • Train and mentor junior study coordinators • Monitor study adherence to the protocol and address deviations • Maintain regulatory compliance and ensure documentation is complete and current • Handle inbound and outbound contacts with patients, healthcare providers, clients, and other sources • Maintain working knowledge of study guidelines, medications, diseases, call scripts, FAQs, procedures, and reference materials • Communicate by phone, fax, and email to retrieve data and address discrepancies • Follow up on missing information, including data entry, documentation, and safety reporting • Complete data entry, filing, and data confirmation accurately and promptly • Apply corrections and updates to secured study applications and appropriate documents • Document communications in application contact logs • Report adverse events as appropriate • Escalate issues requiring management attention • Complete study compliance duties, including stakeholder re-education, non-compliant event documentation, alert/reminder review, and healthcare provider follow-up • Prepare study reporting materials for client meetings • Perform other duties assigned by study leadership and UBC SOPs • Provide study-specific oversight of smaller teams of junior study coordinators, if applicable

🎯 Requirements

• Licensed Practical Nurse or equivalent license in the state of practice • Minimum 2 years of study coordinator experience • Strong understanding of GCP and research ethics • Excellent organizational, time management, project management and communication skills • Proficient in Microsoft Office Suite and electronic medical record (EMR) systems • Ability to work independently and as part of a team • Compassionate and empathetic demeanor for interacting with patients • Ability to work flexible work schedule that could include 24/7 on call coverage shifts • Ability to work on complex programs or multiple programs at the same time requiring critical thought processing • Proficient in multitasking and ability to prioritize tasks

🏖️ Benefits

• Remote opportunities • Competitive salaries • Growth opportunities for promotion • 401K with company match • Tuition reimbursement • Flexible work environment • Discretionary PTO (Paid Time Off) • Paid Holidays • Employee assistance programs • Medical, Dental, and vision coverage • HSA/FSA • Telemedicine (Virtual doctor appointments) • Wellness program • Adoption assistance • Short term disability • Long term disability • Life insurance • Discount programs