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About the role
Key responsibilities & impact- Responsible for the implementation of clinical trial activities per study protocol.
- Works closely with investigative site personnel, CROs, and other study vendors.
- Manage study contracting, budget and payment process for all clinical trial vendors including investigational sites.
- Design study related documents, including but not limited to study protocol, informed consent forms, CRFs, and regulatory binders.
- Train CROs, vendors, investigators and study coordinators on study protocol and relevant requirement.
- Monitor and track clinical trial progress and provide status update to stakeholders.
- Partner with other research and development groups to achieve deliverables.
- Mentor junior clinical operations staff and supervise clinical study team.
- This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job.
Requirements
What you’ll need- Bachelor’s degree in life sciences, or other relevant discipline required, Advanced degree preferred.
- 5-8 years of clinical research experience, including at least 2-5 years of experience in managing clinical trials as a leading role.
- Familiar with the FDA regulations relevant to clinical trials.
- Experience in managing studies, CROs and sponsors is preferred.
- Able to collaborate with the study team, cross functional team members and external collaborators.
Benefits
Comp & perks- Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
- Free testing for Natera employees and their immediate families.
- Fertility care benefits.
- Pregnancy and baby bonding leave.
- 401k benefits.
- Commuter benefits.
- Generous employee referral program.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial activitiesstudy protocol designinformed consent formsCRFsregulatory bindersbudget managementcontract managementmonitoring clinical trial progresstrainingmentoring
Soft Skills
collaborationcommunicationleadershipsupervisionstakeholder management
