Lead Clinical Trial Coordinator
San Diego, California
Expiry Date :
Mon, 21 Dec 2020 23:59:59 GMT
Apply Job :
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 Ref#: Job Summary and Primary ResponsibilitiesThe Lead Clinical Trial Coordinator supports the clinical affairs department with the execution and ongoing maintenance of clinical studies. Maintains, updates, and establishes various databases for clinical document tracking and keeps clinical files current. Oversees the clinical study supply inventory, including ordering and shipping of supplies to study sites. Tracks incoming and outgoing clinical and regulatory documents and is responsible for ensuring prompt and accurate study site payments on a monthly basis. Study Documentation – 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. Payment Processing – 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 – 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. – Assist Clinical and Medical Affairs Leaders in additional responsibilities as required. Required Skills / Capabilities – Excellent communication skills (both written and verbal) with ability to self-manage time and project outcomes – Basic knowledge of medical terminology preferred – Intermediate skills in MS Office applications – Capable project management skills with ability to multitask and manage multiple small to large projects in a cross-functional, cross-regional environment – Strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment – Excellent computer skills, particularly with database applications are required. Proficient and accurate with word processing (Word), spreadsheets (Excel), presentation programs (PowerPoint), EDC, and eTMF/CTMS systems. Education and Experience – Typically requires a minimum of 4 – 6 years of related experience – High school diploma or equivalent required – Bachelors degree preferred – Clinical trial experience preferred Travel and/or Physical Requirements No travel is requiredNuVasive 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. NuVasive’s EEO policy is available here. About NuVasiveNuVasive, 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 .