As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.
Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.
If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!
Sr. Study Coordinator
Shift/ Schedule: Must be flexible to rotating shifts that cover up to midnight EST. Shifts also include rotating weekends, holidays and on-call schedule. Infrequent travel maybe needed for this position.
Brief 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.
Specific job duties:
- 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
Supervisory Responsibility:
- Study specific oversight of smaller teams of junior level study coordinators (if applicable)
Desired Skills and 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:
At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.
Here are some of the exciting perks UBC offers:
- 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
UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.
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