Clinical Research Associate (in-house)
Job Description
Artiva is clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers.
Artiva’s lead product candidate, AlloNK, is a non-genetically modified, off-the-shelf, allogeneic, cryopreserved NK cell therapy designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of mAbs to drive B-cell depletion and to be administered in the community setting. Unlike CAR-T and any genetically modified cell therapy, AlloNK is a non-genetically modified NK cell therapy candidate and has not shown any secondary malignancies in our clinical trials, which is a benefit in an autoimmunity setting. Using the company’s proprietary cell therapy manufacturing platform, Artiva can generate thousands of doses of cryopreserved, infusion-ready AlloNK cells from a single cord blood unit. The FDA has granted Fast Track designation to AlloNK in combination with rituximab or obinutuzumab for the treatment of class III or IV lupus nephritis, and AlloNK in combination with rituximab for the treatment of relapsed or refractory non-Hodgkin lymphoma of B-cell origin (B-NHL).
AlloNK, is currently being evaluated in combination with B-cell targeted mAbs in
patients with autoimmune diseases and cancers, such as lupus nephritis, SLE, rheumatoid arthritis, pemphigus vulgaris, the ANCA-associated vasculitis subtypes GPA/MPA, and B-NHL. In addition, we are also pursuing AlloNK and our CAR-NK product candidates in multiple indications through collaborator-funded trials. Artiva’s cell therapy manufacturing platform incorporates cell expansion and activation technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea.
Artiva is headquartered in San Diego and backed by leading venture investors including 5AM Ventures, RA Capital Management and venBio Partners.
For more information, visit www.artivabio.com.
Job Summary:
The Clinical Research Associate (CRA) supports moderately complex clinical trial activities in support of the Clinical Trial Manager(s). The CRA works closely with the clinical trial team to ensure site related start-up through close-out activities are conducted according to Good Clinical Practice (GCP) and relevant SOPs. The CRA may assist with vendor oversight and management. They will identify issues in a timely manner and escalate to management as appropriate. The CRA may complete monitoring visit report reviews and perform co-monitoring. The core duties and responsibilities of the CRA are delineated below.
Duties/Responsibilities:
- Organizes and supports trial managers in conduct of all study team meetings via agenda and meeting minute preparation, completion and distribution.
- Manages Site Essential Documents review during study start-up, maintenance and close-out.
- Supports the preparation and maintenance of regulatory and study-specific documentation (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)
- Ensures tracking and filing of essential documents in the appropriate tracking systems.
- Ensures tracking of patient status throughout the study at investigative sites.
- Responsible for maintaining internal tracking systems of patient and site status in support of trial and management needs.
- May review and approve trip reports, track data query reports, site visit metrics, and overall site performance.
- May perform site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with local CRAs.
- Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues.
- May assist in the preparation of and may present at investigator vendor meetings and workshops.
- Actively involved in the performance of study feasibility assessments.
- Provides rapid action to address both internal and site QA findings from audits.
- Coordinates the activities of third-party vendors including metrics, accruals, process planning, and implementation.
- Routinely participates in department and clinical trial team meetings and participates in collaborative efforts (e.g. protocol development, CRO selection, departmental initiatives, etc.).
- Support CTM with oversight of TMF completeness, timeliness, and quality of filed documents.
Requirements:
- Bachelor’s degree or higher
- 3 or more years of industry experience from Pharmaceutical, Biotechnology or Contract Research Organization (CRO), to include at least 1 year of site or hospital experience
- Previous site monitoring experience preferred
- Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
- Strong attention to detail and ability to prioritize tasks in a fast-paced environment.
- Good communication skills, both written and verbal, with the ability to work well in cross-functional teams.
- Understanding of study phases and general knowledge of how they apply to clinical development
- Advanced knowledge of Word, Excel, and PowerPoint.
- Knowledge of the principles and practices of computer applications in database management
- Strong verbal and written communication skills required.
- 20% – 30% travel may be required
Base Salary: $100,000 – 125,000. Exact compensation may vary based on skills and experience.