Clinical Research Associate (in-house) jobs in United States
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Artiva Biotherapeutics · 13 hours ago

Clinical Research Associate (in-house)

Artiva Biotherapeutics is a clinical-stage biotechnology company focused on developing NK cell-based therapies for autoimmune diseases and cancers. The Clinical Research Associate (CRA) will support clinical trial activities, ensuring compliance with Good Clinical Practice and assisting with vendor oversight and management.

BiotechnologyLife ScienceTherapeutics

Responsibilities

Organizes, and supports trial managers, in conduct of all study team via agenda and meeting minute preparation, completion and distribution
Manages Site Essential Documents review during study start-up, maintenance and close-out period
Prepare study documents (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 routine monitoring at limited clinical sites
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
Coordinate the activities from 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.)

Qualification

Clinical Practices (GCP)Clinical trial managementSite monitoring experiencePharmaceutical industry experienceBiotechnology experienceContract Research Organization (CRO) experienceDatabase managementCommunication skillsTeam collaborationProblem-solvingAttention to detailTime managementFlexibilityAdaptability

Required

Bachelors degree or higher
3 or more years industry experience from Pharmaceutical, Biotechnology or Contract Research Organization (CRO), to include at least 1 years of site or hospital experience
Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
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

Preferred

Previous site monitoring experience

Benefits

Medical, Dental, and Vision
Group Life Insurance
Long Term Disability (LTD)
401(k) Retirement Plan
Employee Assistance Program (EAP)
Flexible Spending Account (FSA)
Paid Time Off (PTO)
Company paid holidays, including the year-end holiday week
Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.

Company

Artiva Biotherapeutics

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Artiva Biotherapeutics is a biotech company focused on developing and commercializing allogeneic natural killer (NK) cell therapies.

Funding

Current Stage
Public Company
Total Funding
$198M
Key Investors
Venrock Healthcare Capital Partners
2024-07-18IPO
2021-02-26Series B· $120M
2020-06-26Series A· $78M

Leadership Team

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Fred Aslan
President and Chief Executive Officer
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Neha Krishnamohan
Chief Financial Officer & EVP, Corporate Development
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Company data provided by crunchbase