Lead Clinical Research Associate

Digitailor; United States; Remote; USD 90,000 - 150,000; Full time

Benefits offered by this job

Remote opportunities

Competitive salaries

Growth opportunities for promotion

401K with company match*

Tuition reimbursement

Flexible work environment

Discretionary Time Off

Paid Holidays

Employee assistance programs

Medical, Dental, and vi

Job summary

UBC is seeking a Lead Clinical Research Associate (LCRA) to provide clinical project oversight across US, Europe and multinational studies. You will monitor sites, review monitoring reports, and ensure adherence to ICH/GCP, CFR, and sponsor SOPs.

Bachelor’s in Health Care/Life Science, 5+ years site management, and strong English and local language skills are required. Travel up to 30% and collaboration with PM and EDO teams are part of the role.

Qualifications

• Bachelor’s degree in Health Care/Life Science preferred or equivalent industry experience.
• Minimum of 5+ years of site management experience required.
• Knowledge of ICH/GCP, CFR and local country regulations.
• Excellent written and verbal communication in English and local language.
• Proficient in CTMS, eTMF, EDC and sponsor-specific systems.
• Ability to work independently and in cross-functional teams.
• Travel up to 30% may be required.

Responsibilities

• Provide oversight of day-to-day clinical operations from start-up through close-out.
• Review and approve monitoring reports and visits per timelines.
• Lead training for project teams and coordinate sponsor communications.
• Collaborate with PM and EDO Manager on resourcing and cost analysis.
• Coordinate site assignments and ensure audit-ready project systems.
• Mentor project team and assist with regulatory submissions as needed.
• Travel up to 30% to sites as required.

Skills

Communication skills

Leadership

Cross-functional collaboration

Independent work

Education

Bachelor’s degree in Health Care/Life Science

Tools

CTMS

eTMF

EDC

Microsoft Office

Sponsor systems

Job description

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

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 Time Off
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vi