Lead Clinical Research Associate

As a pharmaceutical support industry leader, UBCis devoted toempowering health solutions for a better tomorrow. We takeprideinimprovingpatient outcomes andadvancing healthcare.At UBCwe provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewardingcareer journey with UBC! Growyour career while making a meaningfulimpacton theworldaround you.UBCfosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in aninclusive workplacethat fosters creativity.

If you are seeking a career that willchallenge, inspire,andrewardyou, join us atUBC!

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 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.

Originally posted on Himalayas