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New · posted Oct 31

Orca Bio · Biotechnology

Clinical Research Associate

  • Remote, US
  • Remote
  • Full-time
  • Associate & Specialist
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Pay$90K–$140K
EmploymentFull-time
LocationRemote, US
LevelAssociate & Specialist
FunctionClinical Research
DeadlineOpen until filled

The role

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

Summary of Role: In this Clinical Research Associate role, you will be responsible for monitoring the progress of clinical studies, either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

We are recruiting for two roles: one based on the West Coast and one based on the East Coast. Travel expected: ~1+ site visit per week, for sites that do not permit virtual monitoring.

Personal Qualities

  • Highly detail oriented with special attention to quality and quality control 
  • Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize  
  • Well organized and able to work under tight deadlines
  • Demonstrated strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment 
  • Strong interpersonal skills, including verbal and written communication, are essential
  • Ability to work in a collegial and collaborative manner; independently and as part of a team
  • Ability to work in a fast-paced and informal startup environment
  • Highly tolerant and respectful of all members of our team 
  • Strong problem-solving skills with desire to improve upon established processes
  • Sense of humor

    • The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

    What you need

  • BA/BS or equivalent with a minimum of 3+ years of progressive clinical trial operations and monitoring experience (for CRA role) or 5+ years with lead monitor responsibilities (Senior CRA)
  • Therapeutic experience in oncology/hematology and cell and gene therapy preferred
  • Prior CRA experience working directly for sponsor, ideally a start-up/or small company, with primary site ownership and independent monitoring responsibility
  • Strong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
  • Experience with Trial Master File management according to the DIA reference model
  • Experience operating within various site EMR/EHR systems
  • Experience using eTMF, EDC (IBM Zelta experience ideal), CTMS, and other vendors systems/portals, as well as working on trials without a CTMS in place

    • Skills named in this posting

    What you'll do

  • May serve as the primary monitor and main point of contact for assigned clinical sites
  • Conduct interim monitoring visits (IMVs) and ISF review
  • Review electronic medical records (EMR)/patient data
  • Source documentation verification (SDV) against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements
  • Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
  • Provide support to site staff including research coordinators and physicians
  • Assist in the development of trial materials as needed (e.g., case report forms, monitoring guidelines, site tools and training guides)
  • Contribute to the development of Clinical Operations SOPs, best practices, work instructions, tools and templates
  • Author and submit high-quality monitoring visit reports within required timelines
  • Ensure completeness and accuracy of monitoring documentation in the eTMF

    • Pay and benefits

    $90,000 – $140,000 a year

    Employer provided
    How this compares

    • Pre-IPO equity

    • Annual bonus

    • Medical, dental, and vision

    • PTO

    • 401(k) plan

    • Parental leave

    Dozens of Orca Bio colleagues in hard hats and safety vests waving inside a large manufacturing space

    From the posting

    About Orca Bio

    We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

    We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

    We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

    We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

    Orca Bio company page · 6 open roles
    Equal opportunity, accessibility and legal noticesOrca Bio's statements, word for word

    Notice to staffing firms

    Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

    We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

    Job intelligence

    The context around this role

    Live data · October 31, 2026

    Salary intelligence

    How the pay compares

    This role's midpoint is level with the US median for Clinical Research roles at this level.

    This roleEmployer provided

    $90,000 to $140,000 a year

    Associate & Specialist roles in the US7 roles publishing pay

    Middle half $110,000 to $123,500, median $115,000
    Annual base pay
    Annual base payLowMedianHigh
    This role$90,000—$140,000
    All US$110,000$115,000$123,500

    This role: Orca Bio's own published range. Comparisons: the base pay employers published on open Clinical Research roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.

    Career trajectory

    Where this role sits in Clinical Research

    The general path across 14 open Clinical Research roles on Regulatory Jobs, with the titles they carry most. Not Orca Bio's own promotion track.

    1. This role

      Associate & Specialist

      Often: Clinical Research Associate

      $115K median7 open

    2. Next step

      Senior & Principal

      Often: Senior Clinical Research Associate · Clinical Research Associate

      5 open

    3. Later

      Director

      Often: Associate Director, Site Monitoring · Director, Clinical Trial Liaison

      2 open

    Career resources on Clinical Research

    Skills DNA

    What this role leans on

    How many of the posting's 7 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

    GMP and compliance: 3 linesDocumentation and SOPs: 3 linesInvestigations and CAPA: 2 linesClinical trial conduct: 3 linesCollaboration and leadership: 4 linesGMPDocumentationInvestigationsClinical trialsTeamwork
    • Collaboration and leadership4
    • GMP and compliance3
    • Documentation and SOPs3
    • Clinical trial conduct3
    • Investigations and CAPA2

    Regulatory intelligence

    The rules behind this role

    Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

    From Regulatory News

    Company hiring pulse

    Orca Bio on Regulatory Jobs

    6
    Open roles
    6
    Distinct roles
    4
    Locations

    By discipline

    • Clinical4 67%
    • Regulatory1 17%
    • Quality1 17%

    By level

    • Director3 50%
    • Associate & Specialist2 33%
    • Manager1 17%
    See all 6 Orca Bio roles

    More roles at Orca Bio

    All 6 Orca Bio roles

    Clinical Research Associate at Orca Bio

    Open until filled. $90K–$140K a year, employer provided.

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