Clinical Research Associate

Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve outcomes for patients with blood cancer. The Clinical Research Associate will monitor clinical studies at investigative sites or remotely, ensuring trials are conducted, documented, and reported according to protocols, SOPs, ICH-GCP, and applicable regulations.

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

Preferred

Therapeutic experience in oncology/hematology and cell and gene therapy preferred

Oncology Experience

Hematology Experience

Cell Therapy

Gene Therapy

Benefits

Pre-IPO equity for full-time employment positions

Annual bonus for full-time employment positions

Competitive medical benefits

Dental benefits

Vision benefits

401(k) plan

Life insurance coverage

Accidental death and disability coverage

Parental leave benefits

Subsidized daily lunches and snacks at on-site locations

Remote-based work arrangement

Company

High-precision cell therapies for blood cancer and autoimmune diseases

Menlo Park, California, USA

http://www.orcabio.com/

Founded in 2016

201-500 employees

Qualifications

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)

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

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

Therapeutic experience in oncology/hematology and cell and gene therapy preferred

Required skills

Clinical Trial Monitoring, FDA Regulations, ICH-GCP, Clinical Monitoring Procedures, Trial Master File Management, Electronic Medical Records (EMR/EHR), Electronic Trial Master File (eTMF), Electronic Data Capture (EDC), IBM Zelta, Clinical Trial Management Systems (CTMS), Oncology and Hematology, Cell and Gene Therapy

Experience

3+ years