Senior Clinical Research Associate

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