Senior Study Coordinator

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the execution of clinical research at the UBC Study Coordinating Center, prioritizing participant safety and well-being.

• Facilitate the screening of potential participants, secure informed consent, and gather medical records.

• Arrange and conduct patient telehealth visits while performing assigned study procedures as per the protocol.

• Collect, document, and preserve precise clinical data in line with Good Clinical Practice guidelines.

• Oversee investigational drug logistics, which includes shipping, storage, accountability, and administration.

• Coordinate the comprehensive patient study journey, encompassing home health nursing visits, telehealth visits, site visits, study supplies, sample collection, and ePRO/eCOA/devices.

• Generate reports for the Principal Investigator, Sub-Investigator, and Sponsor.

• Train and guide junior-level study coordinators.

• Monitor adherence to study protocols and identify and resolve deviations.

• Ensure regulatory compliance and maintain up-to-date study documentation.

• Manage communications with patients, healthcare providers, and clients related to UBC studies.

• Stay informed about study guidelines, medications, diseases, call scripts, FAQs, procedures, and reference materials.

• Utilize phone, fax, and email to gather data or rectify discrepancies.

• Follow up on incomplete information, data entry, documentation, and safety reporting.

• Execute timely and accurate data entry, filing, and data confirmation.

• Make corrections and updates to secure study applications and documents.

• Record communications in the appropriate application contact logs.

• Report adverse events when necessary.

• Bring issues needing management attention to the forefront.

• Fulfill study compliance responsibilities, which include re-education of stakeholders, documentation of non-compliance, alert/reminder reviews, and follow-ups with healthcare providers.

• Prepare study reporting materials for client meetings.

• Provide study-specific oversight for smaller junior coordinator teams, if applicable.

• Undertake additional duties as assigned by management in accordance with UBC Standard Operating Procedures.

⛳️ Requirements

• Licensed Practical Nurse or an equivalent license in the relevant state of practice.

• A minimum of 2 years of experience as a study coordinator.

• Strong knowledge of Good Clinical Practice and research ethics.

• Exceptional organizational, time management, project management, and communication skills.

• Proficient in Microsoft Office Suite and electronic medical record (EMR) systems.

• Capable of working independently as well as collaboratively within a team.

• Compassionate and empathetic approach when interacting with patients.

• Flexibility to work a schedule that may include 24/7 on-call coverage shifts.

• Ability to manage complex programs or multiple programs simultaneously, requiring critical thinking skills.

• Skilled in multitasking and prioritizing tasks effectively.

🏝️ Benefits

• Remote work opportunities.

• Competitive salary packages.

• Opportunities for career advancement.

• 401K plan with company matching.*

• Tuition reimbursement program.

• Flexible work environment.

• Discretionary Paid Time Off (PTO).

• Paid holidays.

• Employee assistance programs.

• Comprehensive medical, dental, and vision coverage.

• Health Savings Account (HSA) and Flexible Spending Account (FSA).

• Telemedicine services (virtual doctor appointments).

• Wellness program.

• Adoption assistance.

• Short-term disability coverage.

• Long-term disability coverage.

• Life insurance benefits.

• Employee discount programs.