New · posted Nov 10
BeOne Medicines · Biotechnology
Clinical Research Associate II
- Remote, US
- Remote
- Full-time
- Associate & Specialist
The role
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
The CRA will assume the role of a primary CRA. The CRA will conduct site visits (i.e., PSSV, SIV, IMV, COV) and function as the site manager. The CRA is responsible for building and maintaining relationships with key site personnel and ensures an effective line of communication.
The CRA will also monitor data quality and patient safety through monitoring and site education.
CRAs are to complete all aspects of the clinical monitoring process in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.
What you need
Education/ Education Required
- BS/BA in a relevant scientific discipline and minimum of 2+ years of relevant Clinical Operations experience, and minimum of 1+ years of monitoring experience.
- Experience in global oncology trials preferred.
Computer Skills
- Efficient in Microsoft Word, Excel, PowerPoint and Outlook
- Familiar with industry CTMS and data management systems
- undefined
Other Qualifications
- Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task
- Fluent in English (writing and speaking)
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
What you'll do
Essential Functions of the Job
- Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devices
- Conduct site visits to determine protocol and regulatory compliance, and prepare required documentation
- Develop collaborative relationships with investigative sites, and study vendors
- Provide protocol and related study training to assigned clinical study sites
- Attend disease indication and/or project specific training, as required
- Maintain oversight of site performance by tracking metrics for enrollment, data entry into Case Report Forms (CRFs), protocol deviation trends, and overall site issues
- Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues
- Communicate site performance to the Clinical Study Team (CST)
- Perform study-specific training with project team
- Perform Serious Adverse Event (SAE) reconciliation and work with study sites to resolve discrepancies
- Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.).
- Attend regional investigator meeting and site booster visits, as required
- Provide audit/inspection preparation support to clinical study sites and ensure quality issues or findings are followed to resolution, as needed
- Assist with other assigned clinical responsibilities within scope of role, as required
Supervisory Responsibilities
- Provides site level management for established protocols and portfolio under general supervision
- Provides mentoring/support to CRAs for CRA related topics
- Co-monitoring with CRAs and support site visits, as needed
Pay and benefits
$92,000 – $122,000 a year
Employer providedSalary Range: $92,000.00 - $122,000.00 annually
Medical
Dental
Vision
401(k)
Paid Time Off
Employee Stock Purchase Plan
Working conditions
Travel
- Up to 70% travel
Equal opportunity, accessibility and legal noticesBeOne Medicines's statements, word for word
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 4% above the US median for Clinical Research roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US65 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $92,000 | — | $122,000 |
| All US (middle half) | $85,000 | $102,500 | $125,000 |
This role: BeOne Medicines's own published range. Comparisons: the base pay employers published on open Clinical Research roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Research
The general path across 243 open Clinical Research roles on Regulatory Jobs, with the titles they carry most. Not BeOne Medicines's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 44 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership16
- Clinical trial conduct11
- Documentation and SOPs5
- Investigations and CAPA4
- GMP and compliance3
- Data and digital systems2
- Lab testing and methods1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Research work in biotechnology, led by the one this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
Company hiring pulse
BeOne Medicines on Regulatory Jobs
- 42
- Open roles
- 42
- Distinct roles
- 2
- Locations
By discipline
- Clinical23 55%
- Regulatory11 26%
- Quality7 17%
By level
- Director17 40%
- Manager10 24%
- Senior & Principal10 24%
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Clinical Research Associate II at BeOne Medicines
Open until filled. $92K–$122K a year, employer provided.