Natera
POSITION SUMMARY:
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 RESPONSIBILITIES:
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
Overseeing 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
Monitor and track clinical trial progress, provide status updates to stakeholders
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.
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 and have an access to various technologies to access PHI (paper and electronic) in order to perform the job.
Employee must provide records of current training or complete training relating to HIPAA/PHI privacy, Human Subjects Protection, and GCP.
Must maintain a current status on Natera training requirements including General Policies, Procedure Compliance, and security training
Employee must pass post offer criminal background check
QUALIFICATIONS:
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
KNOWLEDGE, SKILLS AND ABILITIES:
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
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!
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page