Provide high level logistical support for clinical study operations.
Develop study-related documents with minimal Clinical Trial Manager guidance.
Manage small to medium size study contracting, budget, invoicing and payment process.
Support the Clinical Data Management team in the design and content of case report forms.
Manage the preparation, handling, filing, and archiving of clinical documentation and reports.
Overseeing clinical trial supplies related to biospecimen collection, processing, shipment, and storage.
Train CROs, vendors, investigators, and study coordinators on study requirements.
Monitor and track clinical trial progress, provide status updates to stakeholders.
Develop new study monitoring plans and monitor studies to identify protocol deviations or data discrepancies.
Perform study activities including consent participants for research studies.
Update Clinical Department SOPs with guidance from CTM and/or Director.
Partner with other research and development groups at Natera to achieve deliverables.
Perform other duties as assigned.
This role works with PHI on a regular basis both in paper and electronic form.

Requirements

BA/BS degree in life sciences, related field, or equivalent.
Minimum of 4 years of experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields.
Experience with clinical EDC systems.
Familiarity with the organization and structure of the Trial Master File (TMF).
Familiarity with bio sample management, sample processing, and biobanking best practices.
Competency in SOPs, ICH-GCP, FDA Regulations.
Proficiency in MS Word, Excel and PowerPoint.
Demonstrated ability to work independently and lead projects.
Demonstrated analytical skills and ability to identify complicated problems and propose solutions.
Strong interpersonal skills and communication skills (both written and oral).
Excellent writing skills.
Detail oriented, with solid organization and time management skills.

Benefits

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.
Employee referral program.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical study operationsstudy-related document developmentcontract managementbudget managementclinical data managementcase report forms designclinical documentation managementstudy monitoring plansclinical EDC systemsbio sample management

Soft skills

independent workproject leadershipanalytical skillsproblem identificationsolution proposalinterpersonal skillscommunication skillswriting skillsdetail orientedorganization skills