**Clinical Research Associate (San Diego, CA)**
US, US, CA – San Diego
Minimum Level of Education Required:Bachelors Degree
Percentage of Travel:Up to 50%
Location:CA – San Diego
The CRA is responsible for fulfillment of all clinical research objectives in support of product validation and ongoing verification of product safety and performance in pursuit of clinical data compliance to MEDDEV 2.7/1 rev. 4 and EU MDR. Largely site management and field-based site monitoring with additional study responsibilities as required by team.
Essential duties and responsibilities include those listed below. Other duties may be assigned.
· Support in designing/reviewing study documents, including but not limited to, study protocols, case report forms and subject questionnaires, informed consent forms, electronic data capture (EDC) system, and other study tools
· Support study start-up process including IEC/IRB submissions and related communications
· Act as a corporate liaison with the study site. Demonstrate product and procedure knowledge to support study-related questions and provide site training
· Ensure site compliance with applicable regulatory requirements, including on-time submission of IRB reviews and communications, obtaining patient signatures on each applicable consent form, and timely submission of sponsor-generated documents
· Provide comprehensive updates on study site status; communicate relevant information to research and other project team members. Track patient enrollment, compliance, and withdrawal at assigned sites
· Conduct remote and on-site monitoring visits including site qualification visits, site initiation visits, interim monitoring visits, and closeout visits. Activities associated with site visits include, but are not limited to: correspond with the study site prior to and after the visit, review IRB documentation, perform data verification in EDC, ensure protocol and follow-up visit compliance, and generate comprehensive monitoring follow-up letters in a timely manner
· Together with Data Management, generate and ensure resolution of queries and track return. Work with team to create databases and data tracking tools. Ensure effective utilization of the EDC system
· Identify, evaluate, and ensure all protocol violations and adverse/serious adverse events are properly documented and reported to the appropriate authority in the correct time frame, adequately followed, and communicated per company SOPs and regulatory requirements
· Maintain study data and files in accordance with appropriate standards and regulations (ISO14155, FDA 21CFR, GCP, etc.) set forth by global regulatory bodies for device and company specific SOPs
· Support the SpineTRACK Registry to ensure strong site engagement and quality data collection. Perform onsite visits to develop and maintain successful workflows with participating site staff members
· Perform periodic audits of study files at site and/or corporate offices
· Attend sponsor investigator/study coordinator meetings as needed for assigned protocols
· Assist in the generation of abstracts, white papers, presentations, and manuscripts as needed
· Interface as needed with marketing, legal, sales, regulatory, and various other organizational groups to support research efforts
· Assist research and other project team members in additional responsibilities as required
+ Bachelor’s degree in life science, biological science, or related discipline
+ 1-3 years’ experience in clinical trials. Demonstrated track record of effective clinical study site management
+ Knowledge of medical terminology
+ Excellent computer skills, particularly with database applications are required.Proficient and accurate with word processing (Word), spreadsheets (Excel), presentation programs (PowerPoint), and EDC systems
+ Working knowledge of spine, the spinal implant market, minimally invasive products, and surgical spine techniques
+ Working knowledge European Union Medical Device Regulation requirements for clinical trial conduct
+ Knowledge of PubMd search strategies, understanding of medical writing style and referencing (AMA standard), and understanding of medical research methodology, study design, and statistical concepts
+ Experience and proficiency using statistical software (SPSS, SAS/JMP)
NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm . NuVasive’s EEO policy is available here at https://www.nuvasive.com/wp-content/uploads/2019/06/COP-NUV-HR0004-7.pdf .
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings.With more than $1 billion in revenues, NuVasive has approximately 2,600 employees and operates in more than 50 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com at http://www.nuvasive.com/ .
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NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .
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