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Requirements and responsibilities
Summary: In this Clinical Research Associate role (may be contract or full-time employee), 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. You can be based anywhere in the U.S., although east coast is preferred. 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 sitesConduct interim monitoring visits (IMVs) and ISF reviewReview electronic medical records (EMR)/patient dataSource 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 requirementsVerification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocolProvide support to site staff including research coordinators and physiciansAssist 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 templatesAuthor and submit high-quality monitoring visit reports within required timelinesEnsure completeness and accuracy of monitoring documentation in the eTMFDesired 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)Therapeutic experience in oncology/hematology and cell and gene therapy preferredPrior CRA experience working directly for sponsor, ideally a start-up/or small company, with primary site ownership and independent monitoring responsibilityStrong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring proceduresExperience with Trial Master File management according to the DIA reference modelExperience operating within various site EMR/EHR systemsExperience using eTMF, EDC (IBM Zelta experience ideal), CTMS, and other vendors systems/portals, as well as working on trials without a CTMS in placePersonal 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 deadlinesDemonstrated strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment Strong interpersonal skills, including verbal and written communication, are essentialAbility to work in a collegial and collaborative manner; independently and as part of a teamAbility to work in a fast-paced and informal startup environmentHighly tolerant and respectful of all members of our team Strong problem-solving skills with desire to improve upon established processesSense of humorFull-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 areWe 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 firmsOrca 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.
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