Senior Study Coordinator

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

📋 Description

• Assist in the execution of clinical research from the home-based UBC Study Coordinating Center.

• Aid in screening potential participants, securing informed consent, and obtaining medical records.

• Arrange and conduct patient telehealth appointments and carry out study procedures assigned by the Principal Investigator (PI) as specified in the protocol.

• Gather, document, and uphold precise clinical data in accordance with Good Clinical Practice (GCP) standards.

• Oversee the logistics of investigational drugs, including shipping, storage, accountability, and administration.

• Coordinate the comprehensive patient participation journey, encompassing home health nursing visits, telehealth consultations, in-person site visits, study supply shipments, sample collection, and ePRO/eCOA/device technologies.

• Prepare reports for the PI, Sub-Investigator (Sub-I), and Sponsor.

• Mentor and train junior study coordinators.

• Monitor compliance with the study protocol and address any deviations.

• Ensure regulatory compliance and maintain complete and current documentation.

• Manage inbound and outbound communications with patients, healthcare providers, clients, and other sources.

• Keep an up-to-date understanding of study guidelines, medications, diseases, call scripts, FAQs, procedures, and reference materials.

• Communicate via phone, fax, and email to collect data and resolve discrepancies.

• Follow up on any missing information, including data entry, documentation, and safety reporting.

• Accurately and promptly complete data entry, filing, and data confirmation.

• Implement corrections and updates to secured study applications and related documents.

• Record communications in application contact logs.

• Report adverse events as necessary.

• Elevate issues that require management's attention.

• Fulfill study compliance responsibilities, including stakeholder re-education, documenting non-compliant events, conducting alert/reminder reviews, and following up with healthcare providers.

• Prepare materials for study reporting during client meetings.

• Perform additional duties as assigned by study leadership and UBC Standard Operating Procedures (SOPs).

• Offer study-specific oversight for smaller teams of junior study coordinators, if applicable.

⛳️ Requirements

• Licensed Practical Nurse or equivalent licensure in the state of practice.

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

• Strong knowledge of GCP and research ethics.

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

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

• Capability to work 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 availability.

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

• Skilled in multitasking and capable of prioritizing tasks effectively.

🏝️ Benefits

• Opportunities for remote work.

• Competitive salary packages.

• Advancement opportunities for career growth.

• 401K plan with company matching.

• Tuition reimbursement programs.

• Flexible work environment.

• Discretionary Paid Time Off (PTO).

• Paid holidays.

• Employee assistance programs.

• Medical, dental, and vision insurance coverage.

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

• Telemedicine services (virtual doctor appointments).

• Wellness initiatives.

• Adoption assistance programs.

• Short-term disability insurance.

• Long-term disability coverage.

• Life insurance options.

• Discount programs for employees.