Associate II, Field Clinical Monitoring

12954BR

Title:

Associate II, Field Clinical Monitoring

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.

Auto req ID:

12954BR

Location MV:

Aliso Viejo, California, USA

Department Name:

652-Clinical Admin-Pre Market Operations

Qualifications:

1. Bachelor's degree in a related field of study, preferably in Life Science, or equivalent combination of education and experience.

2. Minimum four (4) years of medical device monitoring experience.

3. Minimum two (2) years of neurovascular experience.

4. Strong knowledge of FDA regulations for clinical trials and clinical procedures.

5. Strong collaborative skills with demonstrated ability to work with physicians, site coordinators, and others within the company.

6. Experience using technologies for clinical research (electronic data capture and clinical trial management systems).

7. Excellent written and verbal communication skills, including computer literacy.

8. Strong computer skills including MS Office (e.g., Word, Excel, Access, PowerPoint, Outlook, Teams, etc.).

Desired Qualifications

1. Proven clinical research expertise in various therapeutic areas.

2. 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

Posting Country:

US - United States

Salary Range:

$96,210 - $126,275 (Financial compensation packages may be higher/lower than 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.