**Lead Clinical Trial Coordinator**
US, US, CA – San Diego
Minimum Level of Education Required:Bachelors Degree
Percentage of Travel:No travel required
Location:CA – San Diego
**Summary:** Responsible for administratively supporting study operations of the Clinical Affairs Team in pursuit of clinical data compliance to MEDDEV 2.7/1 rev. 4 and EU MDR.Works closely with Clinical Affairs and Medical Affairs Leaders, field Clinical Research Associates (CRAs), Data Management, study site personnel, and outside vendors to ensure program goals are met.
**Essential duties and responsibilities** include those listed below. Other duties may be assigned.
+ Maintain systems for filing, organizing, and maintaining study documents, including, case report forms, International Ethics Committee/Institutional Review Board (IEC/IRB) documentation, sponsor-generated documents, and related communications in the central clinical files
+ Perform periodic audits of the central clinical files
+ Assist with new IEC/IRB submissions and processing of continuing review applications
+ Perform duties in compliance with applicable global regulations, company-specific SOPs, and standards including, but not limited to, EU MDR, ISO14155, and FDA 21CFR as applicable to Good Clinical Practice for Medical Devices
+ Populate budget/payment trackers for new and ongoing studies to process monthly site payments. Coordinate with CRAs to ensure accurate and timely processing.
+ Process and track invoices and interface with accounts payable department to ensure timely payments to sites, IRBs, and other vendors.
+ Support CRAs to ensure requests from study sites are met in a timely manner
+ Maintain systems to ensure adequate study inventory; order and ship study supplies to sites as needed
+ Organize in-house meetings, document meeting minutes, and track action items
+ Assist in mailings, letter generation, shipping, and other administrative duties for the Clinical Affairs Department
+ AssistClinical Affairs and Medical Affairs Leadersin additional responsibilities as required.
+ Bachelor’s degree required with 0 to 2 years related clinical trial experience
+ Excellent communication, organization, and prioritization skills
+ Excellent computer skills, particularly with database applications are required
+ Proficient and accurate with word processing (Word), spreadsheets (Excel), presentation programs (PowerPoint), and EDC systems
+ Basic knowledge of medical terminology preferred
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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