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POSITION SUMMARY :

Job Function : Clinical Operations

Title : Senior Clinical Research Associate

The Senior Clinical Research Associate is responsible for the overall operational execution of clinical studies on one or more clinical projects / programs, from study concept through study completion.

This position will perform required job duties with guidance from Clinical Trial Managers to ensure that trial timelines, costs, and quality metrics are met, and the study is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements helps design and execute clinical research activities.

PRIMARY RESPONSIBLITIES

• Provide high level logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out for clinical research studies and collaborations
• Develop study-related documents with minimal Clinical Trial Manager guidance including : protocol, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required
• Manage small to medium size study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites with minimal oversight
• Support the Clinical Data Management team in the design and content of case report forms, completion guidelines, including support and testing of an EDC
• Manage the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements
• Oversees clinical trial supplies related to biospecimen collection, processing, shipment, and storage as, well as maintenance of associated tracking information
• Train CROs, vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
• Develop new study monitoring plans, and monitor studies following study monitoring plans to identify protocol deviations or data discrepancies
• Perform study activities including consent participants for research studies, ethics board submissions, participant data and sample tracking using in-house and CRO databases, for studies where Natera functions as a Clinical Research Site Partner with other groups such as Medical Affairs, R&D, and Product at Natera to achieve deliverables
• Provides operational and logistical support such as sample tracking to support one or more Natera clinical trials / studies or initiative projects
• Ability to work on and communicate complex issues internally and externally (with sites, vendor or collaborators) where analysis of situations or data require in-depth evaluation of various factors, including impact on Natera
• May be asked to provide project status updates of a defined scope to senior leaders within Natera
• Demonstrates increased mastery of job requirements and willingness to train and mentor others
• Demonstrates influence on peers and managers through demonstrated technical knowledge and positive regard for others
• Exercises judgment in evaluating the criteria to achieve expected results -Seeks guidance from manager as needed to determine the best course of action
• This role works with PHI on a regular basis both in paper and electronic form and has access to various technologies to access PHI (paper and electronic) in order to perform the job
• Must maintain a current status on Natera training requirements
• Performs other duties as assigned

QUALIFICATIONS

• BA / BS degree in life sciences, related field, or equivalent
• Minimum of 3 years of experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields
• Previous relevant job experience preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Familiarity with biospecimen management, sample processing, and biobanking best practices
• Experience with clinical EDC systems
• Familiarity with the organization and structure of the Trial Master File (TMF)
• Competency in SOPs, ICH-GCP, FDA Regulations
• Proficiency in Google Workspace (gSuite), MS Word, Excel and PowerPoint
• Demonstrated ability to work independently
• Outgoing and confident demeanor
• Demonstrated analytical skills and ability to identify problems and propose solutions
• Detail oriented, with solid organization and time management skills

PHYSICAL DEMANDS & WORK ENVIRONMENT

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer is required.

May stand for extended periods when facilitating meetings or walking in the facilities.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods.

Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location.

This may differ in other locations due to cost of labor considerations.San Carlos, CA $116,100 $160,000 USD

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other.

When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.

Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits.

Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

Last updated : 2024-07-11

Salary : $116,100 - $160,000