Sr. Study Coordinator

About the role

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

Responsibilities

• Support 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
• Provide 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
• Report any adverse events as appropriate
• Escalate potential problems or issues that require management’s immediate attention
• Ensure all study compliance duties (including re-education of stakeholders, documentation of non-compliant event, review of alerts/reminders, and healthcare provider follow-up) are completed
• Prepare study reporting materials for client meetings
• Other duties as assigned by the Project Manager, Coordinating Center Manager, Coordinating Center Director, and as determined by UBC SOPs

Supervisory Responsibility

• Study-specific oversight of smaller teams of junior level 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