Associate II, Field Clinical Monitoring (U.S. Remote)

Lensa is a career site that helps job seekers find great jobs in the US. We are not a staffing firm or agency. Lensa does not hire directly for these jobs, but promotes jobs on LinkedIn on behalf of its direct clients, recruitment ad agencies, and marketing partners. Lensa partners with DirectEmployers to promote this job for Terumo Neuro. Clicking "Apply Now" or "Read more" on Lensa redirects you to the job board/employer site. Any information collected there is subject to their terms and privacy notice.

12954BR

Title

Associate II, Field Clinical Monitoring (U.S. Remote)

Job Description

Responsible for driving study execution and operational excellence in accordance with ICH Good Clinical Practices, FDA regulations, guidance documents, and company SOPs. Provide oversight of site compliance with study protocols, informed consent procedures, and data integrity requirements. Ensure accurate documentation, timely reporting, and consistent implementation of best practices. Job duties:

• Identify, develop, and maintain investigators and sites capable of delivering start-up goals, enrollment targets, and required data quality.
• Facilitate and maintain open communication among investigational sites, study and data management teams, and the company. Ensure effective communication with key stakeholders.
• Work closely with Project Manager(s) to ensure clinical studies are conducted in accordance with the protocol, GCP, company SOPs, and all applicable regulations (e.g., FDA).
• Understand, read, and deploy study documentation including informed consents, study forms, and study training documents.
• Responsible for collecting and reviewing essential documents, facilitating necessary corrections, and filing in assigned system(s).
• Maintain device accountability records.
• Review data and source documentation from investigational sites for accuracy and completeness; facilitate resolution of data queries and manage action items to completion.
• Conduct and perform site initiation visits, site training, interim monitoring visits, and close-out visits.
• Maintain accurate, detailed, and complete records of monitoring visits and reporting findings according to plans and processes.
• Collaborate with sites to ensure adherence to compliance requirements and escalate non-compliance when necessary.
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.
  
  

Salary Desired

$91,629-$114,536 Financial compensation packages may be higher/lower than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.

Auto Req ID

12954BR

Location MV:

Aliso Viejo, California, USA

Department Name

652-Clinical Admin-Pre Market Operations

Qualifications

• Bachelor's degree in a related field of study, preferably in Life Science, or equivalent combination of education and experience.
• Minimum four (4) years of medical device monitoring experience.
• Minimum two (2) years of neurovascular experience.
• Strong knowledge of FDA regulations for clinical trials and clinical procedures.
• Ability to travel M-F, 4 weeks a month (75%-100%)
• Strong collaborative skills with demonstrated ability to work with physicians, site coordinators, and others within the company.
• Experience using technologies for clinical research (electronic data capture and clinical trial management systems).
• Excellent written and verbal communication skills, including computer literacy.
• Strong computer skills including MS Office (e.g., Word, Excel, Access, PowerPoint, Outlook, Teams, etc.).
  
  

Desired Qualifications

• Proven clinical research expertise in various therapeutic areas.
• Experience in a catheter lab environment.
  
  

EEO

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

Fair Chance Ordinance

If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.

External-Facing Title

Associate II, Field Clinical Monitoring (U.S. Remote)

Posting Country

US - United States

Salary Range

$91,629-$114,536 Financial compensation packages may be higher/lower than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.)

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.

If you have questions about this posting, please contact support@lensa.com