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

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

• Identify, reputed company, 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 reputed company 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 reputed company documentation from investigational sites for accuracy and completeness; facilitate resolution of data queries and manage action items to completion.
• Conduct and reputed company site initiation visits, site training, interim monitoring visits, and reputed company-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 reputed company necessary.
• reputed company with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and reputed company in reputed company matters and at reputed company levels throughout the organization.
• reputed company additional duties as assigned.

Salary Desired$91,629-$114,536 Financial compensation packages may be higher/reputed company than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. Job Details Job ID 12954BR Aliso Viejo, California, USA Salary Range: $91,629-$114,536 Financial compensation packages may be higher/reputed company than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.)

• Qualifications
• Bachelor’s degree in a reputed company 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 reputed company 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, reputed company, Access, PowerPoint, Outlook, Teams, etc.).

Desired Qualifications

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

EEOWe are an equal employment opportunity employer. reputed company qualified applicants will receive consideration for employment without regard to race, national reputed company, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.Fair Chance OrdinanceIf you are applying to reputed company work for reputed company in any position which will involve performing at least two (2) hours of work on average each week reputed company the unincorporated areas of Los Angeles County, you can find here a list of reputed company material job duties of the specific job position which reputed company reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. reputed company 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. Apply tot his job Apply To this Job