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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.

Responsibilities:

• 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

Qualifications:

• BA/BS or equivalent with a minimum of 2+ years of CRA 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

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

$90,000 - $140,000 a year

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.

Who we are

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.

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.

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 may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

At Clover Health, our mission is simple but powerful: to improve every life by delivering care that is high-quality, accessible, and rooted in compassion and innovation. Our Clover Care Services (CCS) team brings this mission to life by offering personalized, proactive support to our members while partnering closely with providers to elevate outcomes across the community. Powered by Clover Assistant, our advanced data-driven platform, we combine technology with the heart of caregiving, empowering patients, supporting providers, and transforming the way care is delivered.

We are seeking compassionate and driven Lead Physicians and Staff Physicians to join our dynamic Clover Home Care team across Albany/Thomasville/Macon, Georgia. This is a unique opportunity to provide comprehensive primary and supportive care directly in the homes of our most vulnerable members, improving both health outcomes and quality of life.

As a Staff Physician, you will:

• Oversee the care and outcomes for a patient cohort, managing cases directly and in collaboration with our team of nurse practitioners.
• Conduct in-home and telehealth visits for Medicare Advantage members, leveraging our technology (Clover Assistant and EMR) to deliver high-quality, preventive care.
• Coordinate with members’ interdisciplinary care teams and other providers to create personalized care plans and actively close gaps in care.

In addition to the responsibilities outlined above, the Lead Physician will:

• Provide clinical leadership and mentorship by guiding and supporting nurse practitioners, fostering professional growth, and ensuring the delivery of high-quality, compassionate care across the Clover Home Care team.
• Advance clinical excellence and outcomes by leading quality improvement initiatives, conducting assurance reviews, and collaborating with the Medical Director and Practice Manager to optimize care processes and performance.

You should get in touch if:

• You hold an MD or DO degree and are board-certified in Internal Medicine, Family Medicine, or Geriatric Medicine.
• You are excited about practicing in Georgia, we welcome the opportunity to support relocation for exceptional providers looking to make this region their home.
• You are (or are willing to become) licensed in Georgia, with DEA and CDS registrations, we will support you in obtaining these if needed.
• You bring a minimum of five years of advanced clinical practice experience, with proven expertise in chronic disease management and a strong commitment to improving the lives of vulnerable senior populations.
• You have prior experience in home care (preferred).
• You are excited about technology and embrace its use to drive high-quality clinical care and improve member outcomes.

Benefits Overview:

• Financial Well-Being: Our commitment to attracting and retaining top talent begins with a competitive hourly rate. Additionally, we offer a performance-based bonus program, 401k matching, and regular compensation reviews to recognize and reward exceptional contributions.

• Physical Well-Being: We prioritize the health and well-being of our employees and their families by providing comprehensive medical, dental, and vision coverage. Your health matters to us, and we invest in ensuring you have access to quality healthcare.

• Mental Well-Being: We understand the importance of mental health in fostering productivity and maintaining work-life balance. To support this, we offer initiatives such as company holidays, access to mental health resources, and a generous time-off policy.

  • Full-time hourly employees accrue up to 18 days of vacation per year.
  • Clover recognizes 10 federal holidays, including New Year’s Day, Juneteenth, and Christmas. There are also 4 additional paid holidays, and 1 floating holiday.

• Professional Development: Developing internal talent is a priority for Clover. We offer learning programs, mentorship, professional development funding, and regular performance feedback and reviews.

Additional Perks:

• Reimbursement for office setup expenses
• Monthly internet stipend
• Employee Stock Purchase Plan (ESPP) offering discounted equity opportunities
• Paid parental leave for all new parents
• And much more!

About Clover: We are reinventing health insurance by combining the power of data with human empathy to keep our members healthier. We believe the healthcare system is broken, so we’ve created custom software and analytics to empower our clinical staff to intervene and provide personalized care to the people who need it most.

We always put our members first, and our success as a team is measured by the quality of life of the people we serve. Those who work at Clover are passionate and mission-driven individuals with diverse areas of expertise, working together to solve the most complicated problem in the world: healthcare.

From Clover’s inception, Diversity & Inclusion have always been key to our success. We are an Equal Opportunity Employer and our employees are people with different strengths, experiences, perspectives, opinions, and backgrounds, who share a passion for improving people’s lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion and many other parts of one’s identity. All of our employee’s points of view are key to our success, and inclusion is everyone’s responsibility.

Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. We are an E-Verify company.

A reasonable estimate of the base salary range for this role is $220,000 to $260,000. Final pay is based on several factors including but not limited to internal equity, market data, and the applicant’s education, work experience, certifications, etc.

Final pay is based on several factors including but not limited to internal equity, market data, and the applicant’s education, work experience, certifications, etc.

A reasonable estimate of the base salary range for this role is:

$220,000—$240,000 USD