[Hiring] Sr. Study Coordinator @United Biosource Corporation

Role Description

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.

• Supporting 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.
• 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.
• Responsible for reporting any adverse events as appropriate.
• Escalate potential problems or issues that require management’s immediate attention.
• Responsible for ensuring 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.
• Preparation of 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.

Qualifications

• 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.