Senior Study Coordinator

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

📋 Description

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

• Schedule and conduct telehealth appointments for patients, as well as perform delegated study procedures.

• Gather, document, and uphold precise clinical data in accordance with Good Clinical Practice guidelines.

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

• Coordinate the entire study participation process for patients, encompassing nursing visits, telehealth consultations, site visits, supplies, samples, and ePRO/eCOA/devices.

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

• Train and guide junior study coordinators.

• Monitor adherence to protocols and identify as well as address any deviations.

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

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

• Retrieve data, resolve discrepancies, conduct follow-ups, and document communications.

• Complete data entry, filing, data verification, corrections, and updates in study-related applications and documents.

• Report adverse events and escalate issues that require management attention.

• Fulfill study compliance responsibilities, including re-education for stakeholders and follow-up with healthcare providers.

• Prepare study reporting materials for client meetings.

• Provide specific oversight for smaller teams of junior coordinators, if applicable.

• Undertake additional duties as assigned by management and according to UBC standard operating procedures.

⛳️ Requirements

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

• At least 2 years of experience as a study coordinator.

• Solid understanding of Good Clinical Practice 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 variable schedule, potentially including 24/7 on-call coverage shifts.

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

• Skilled in multitasking and prioritizing tasks effectively.

🏝️ Benefits

• Opportunities for remote work.

• Competitive salary packages.

• Opportunities for career advancement.

• 401K plan with company matching.

• Tuition reimbursement programs.

• Flexible work environment.

• Discretionary paid time off (PTO).

• Paid holidays.

• Employee assistance programs.

• Comprehensive medical, dental, and vision insurance.

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

• Access to telemedicine services (virtual doctor appointments).

• Wellness program offerings.

• Adoption assistance support.

• Short-term and long-term disability coverage.

• Life insurance options.

• Employee discount programs.