New

Sr Clinical Research Assoc

US Remote

POSITION SUMMARY:

The Clinical Research Associate helps support execution of clinical research studies, including site management, training, data monitoring, ethics board approval and submission management, and budget and contract review. This position will perform required job duties with oversight from the study Clinical Trial Manager in compliance with the study protocol, SOPs, and applicable regulatory requirements.

PRIMARY RESPONSIBILITIES:

  • Provide logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out.
  • Develop study-related documents with Clinical Trial Manager guidance including: informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required
  • Assist with managing study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites
  • Support the Clinical Data Management team in the design and content of CRFs, completion guidelines, including support and testing of an EDC system
  • Assist in 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   
  • Monitor and track clinical trial progress, provide status update reports to Clinical Trial Manager
  • Train CROs, vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
  • Monitor studies following study monitoring plans to identify protocol deviations or data discrepancies
  • Perform study activities including consent, ethics board submissions, participant data and sample tracking using in-house and CRO databases, for studies where Natera functions as a Clinical Research Site.
  • Support prospective sample testing for studies where Natera functions as a central testing facility
  • Partner with other research and development groups at Natera to achieve deliverables
  • 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 requirement including General Policies and Procedure Compliance and security training.

QUALIFICATIONS:

  • BA/BS degree in life sciences, related field, or equivalent
  • Minimum of 2 years of experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields
  • Early Cancer Detection experience is highly desired

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
  • Outgoing and confident demeanor
  • Demonstrated analytical skills and ability to identify problems and propose solutions
  • Detail oriented, with solid organization and time management skills

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.

Remote USA

$98,600 - $123,200 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!

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 

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