Lead Clinical Research Associate

UBC; United States; Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Remote opportunities

Growth opportunities for promotion

401K with company match*

Flexible work environment

Paid Holidays

Employee assistance programs

Medical, Dental, and vision coverage

Wellness program

Short term disability

Long term disability

Life insurance

Job summary

UBC in the United States is seeking a Lead Clinical Research Associate to provide clinical project oversight and support to the project management team. The role requires monitoring and site management across US, Europe and multinational studies in line with ICH/GCP, CFR regulations, and sponsor SOPs.

You will lead day-to-day operations, review monitoring reports, train team members, coordinate sponsor and PM meetings, manage regulatory submissions, and ensure audit-ready systems such as eTMF

Qualifications

• Bachelor’s degree in Health Care/Life Science or equivalent industry experience.
• Minimum 5+ years of site management experience, with preference for 2+ years field monitoring.
• Knowledge of local country laws applicable to clinical trials and observational studies.
• Proficient in ICH/GCP and sponsor SOPs; strong English and local language communication.
• Proven ability to work independently and in cross-functional teams.

Responsibilities

• Oversee day-to-day clinical operations across US/Intl projects and ensure adherence to study plans.
• Review monitoring reports and oversee site visit scheduling and documentation.
• Lead and mentor project team members; coordinate sponsor and PM meetings.
• Assist with regulatory submissions, contract negotiations, and vendor oversight as needed.
• Maintain audit-ready systems (eTMF, CTMS, EDC) and support feasibility assessments.

Skills

Site management

Monitoring

Leadership

Communication

English & local language

Education

Bachelor's degree in Health Care/Life Science

Tools

CTMS

eTMF

EDC

MS Office

Job description

Lead Clinical Research Associate

UBC / EDS / CRA - WPK Regular Research & Clinical Remote, US

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!

Job Title:YLM03H – Lead Clinical Research Associate (LCRA)

Brief Description: Provides clinical project oversight and support to the project management (PM) team. Provides oversight and manages clinical monitoring and site management portions of projects in accordance with ICH/GCP, CFR guidelines, regional or country regulations/ legislations, as well as UBC and sponsor SOPs.

Specific job duties:

• Thorough knowledge of sponsor-specific project requirements, scope, protocol and timelines
• Provides oversight of the day-to-day clinical operations of US, European and/or multi-national global projects from start-up through close-out
• Reviews and approves monitoring reports and letters within UBC and/or sponsor timelines
• Leads and assists with UBC and project-specific training
• Ensures appropriate visit scheduling per protocol; tracks, reports and escalates adherence to site visit schedule, trip report metrics and documentation of completed tasks
• Provides oversight of the issues & actions and protocol deviations to ensure timely resolution per UBC and/or sponsor timelines
• Serves as primary liaison for monitoring issues, escalating to PM and/or Evidence Development Operations (EDO) Manager when appropriate
• Assists with preparation and leading of sponsor, project team and UBC meetings
• Assists as back-up for PM and may be primary contact for UBC/sponsor interaction
• Collaborates with PM to provide input into resourcing, analyzing cost variances, out-of-scope management, and conducting revenue recognition as applicable
• Coordinates site assignments for team in conjunction with PM and EDO Manager
• Monitors clinical operations aspects of the project against the established plans, SOPs and KPIs ensuring compliance
• Assists PM with the creation and maintenance of project-specific documents
• Responsible for maintenance of audit-ready project systems (eTMF, CTMS, project-specific systems) as related to clinical operations
• Mentors and supports project team
• May include reviewing the preparation, submission and tracking of Competent Authority (CA), Central and Local Ethics Committee and other regulatory applications, as per country requirements
• May include oversight of contract negotiation activities with the sites as per country requirements
• May be required to perform site monitoring as needed.
• May review and provide oversight of study feasibility assessments
• May assist PM and EDO Manager with management of Vendor CRAs
• May require up to 30% travel
• Assists with other duties as assigned

Supervisory Responsibility:

• N/A

Desired Skills and Qualifications:

• Bachelor’s degree in Health Care/Life Science preferred or equivalent industry experience
• Minimum of 5+ years of site management experience required with preference of 2 years field monitoring experience
• Knowledge and understanding of the local country laws applicable to clinical trials and observational studies
• Proficient in the operational methodologies of clinical trials and observational studies
• Thorough knowledge of medical terminology, ICH/GCP and UBC SOPs
• Excellent written and verbal communication skills in English and local language
• High attention to detail
• Excellent critical thinking and resolution skills
• Displays leadership, organizational, communication, time management and interpersonal skills
• Proven skills with CTMS, eTMF, EDC, Microsoft Office, basic computer software and sponsor specific systems
• Ability to work independently and within a cross-team environment.
• Confident in taking responsibility for operational day-to-day project oversight
• Ability to coordinate monitoring project activities at local, national, and international studies

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
• Growth opportunities for promotion
• 401K with company match*
• Flexible work environment
• Discretionary Time Off
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision coverage
• HSA/FSA
• Wellness program
• Adoption assistance
• Short term disability
• Long term disability
• Life insurance

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.