Sr 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:YLM02H - Senior Clinical Research Associate (SCRA)

Brief Description: Monitors clinical trials and observational studies ensuring protocol adherence, managing site activities, and overseeing data collection and integrity. Ensures sites are conducting the study(ies) and reporting study data as required by applicable regulations and guidelines, and sponsor requirements. Mentors and trains junior level CRAs.

Specific job duties:

Thorough knowledge and application of project specific protocol

Performs remote and on-site monitoring in accordance with project specific timelines

Completes travel scheduling in accordance with project specific and UBC travel policy

Submits expense reports within UBC requirements

Attends project team meetings, department meetings and one-to-one meetings with the manager

Completes site monitoring reports and letters per UBC and/or sponsor SOPs requiring minimal corrections

Ensures follow-up of site issues and action items per UBC/sponsor timelines

Enters site visits, site monitoring reports, follow-up letter sent date and site contacts into UBC’s Clinical Trial Management System (CTMS)

Monitors within Electronic Data Capture (EDC) data entry, if applicable, and assists sites with electronic Case Report Form (eCRF) resolution

Reviews Investigator Site File and performs Investigational Product reconciliation

Maintains regular contact with assigned sites per study requirements

Completes all SOP review, training assessments and documentation within requested timelines

Assists Project Manager (PM) and management team by mentoring, training and assessing junior CRAs

Assists with preparation and/or delivery of presentations for UBC CRA training, departmental training and/or sponsor specific training

Assists PM and/or Lead CRA with additional tasks as needed

Travel up to 80% required in the North American region

Completes Site Management and Monitoring activities in accordance with project specific plans and timelines

Assists with other duties as assigned, which may align with other departments at UBC

Supervisory Responsibility:None

Desired Skills and Qualifications:

Bachelor’s degree – Life Science preferred or equivalent years of industry and clinical research experience

Minimum of 36 months on-site monitoring experience including site selection, initiation, management, and monitoring activities

Comprehensive knowledge of medical terminology and regulatory guidelines

Excellent critical thinking and resolution skills

Excellent written and verbal communication skills in English and local language (as applicable)

Experience working in clinical trials and observational studies preferred

Experience and familiarity with CTMS, eTMF, EDC, Microsoft Office applications

Proven ability to deliver highly accurate work and adhere to deadlines in a fast-paced environment

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.

Originally posted on Himalayas