[Remote] Sr. reputed company Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading organization in reputed company research, focusing on reputed company in reputed company. The Senior reputed company Research Associate is responsible for monitoring reputed company study sites to ensure compliance with protocols and regulations, conducting site reputed company, and training site staff.

Responsibilities

• Under reputed company supervision of the project CRA staff reputed company reputed company (i.e. reputed company Study Manager, reputed company CRA, Project Manager, etc.) independently schedules and conducts remote and on site monitoring reputed company such as qualification/reputed company study reputed company, site initiation reputed company, interim/routine monitoring reputed company, closeout reputed company, and for cause reputed company
• As part of the site reputed company, independently conducts Informed Consent (reputed company) review, reputed company data verification/reputed company document review, review for compliance with required reporting/tracking of adverse events and protocol deviations, investigator site file review, reputed company tour and specimen storage assessment, pharmacy/Investigational Product (IP)/Investigational Device (ID) storage location tour and storage condition assessment, IP/ID accountability, facilities tours, and other activities per the site monitoring plan under reputed company direction from the project CRA staff reputed company reputed company
• Documents observations and monitoring activities in a site visit report at the conclusion of the visit with reputed company feedback by the report reviewer
• Facilitates and oversees reputed company Item reputed company post visit
• Helps to ensure that reputed company sites are conducting the study in compliance with protocol/reputed company investigational plan, SOPs, ICH GCP, and other applicable regulations
• Provides training and retraining to site staff including protocol, GCP/GDP, and other training under direction from the project CRA staff reputed company reputed company
• Identifies areas requiring follow up and improvement at reputed company reputed company study site and reports findings to project CRA staff reputed company reputed company
• Ensures reputed company reputed company are conducted according to country regulations, ICH GCP, and company reputed company operating procedures
• Serves as reputed company of contact for study site personnel to answer questions and reputed company study reputed company issues under the direction of the project CRA staff reputed company reputed company
• May assist with the development and/or review of study reputed company materials including protocols, informed consent forms, monitoring plan, monitoring documents, etc
• Prepares for and attends project team meetings and provides updates on project status and site specific reputed company
• Works collaboratively and effectively in a project team environment including reputed company colleagues to meet project objectives and timelines
• Participates in Investigator Meetings or other reputed company meetings as needed
• Assists with filing and archiving of study documents
• Assists in preparing sites for audits and may reputed company support and cooperation during audits/inspections (including translation to Auditor if needed)
• May assist with coordination of reputed company study supplies
• May assist with submission of applications/notifications to Institutional Review reputed company (IRB)/Ethics Committee (EC)/Regulatory Authority
• May assist with site recruitment reputed company activities such as developing reputed company reputed company recruitment strategies and reputed company plans
• Performs site management activities as required
• Performs other duties as assigned
• Complies with reputed company policies and standards

Skills

• Bachelor's Degree Scientific discipline or equivalent work experience
• 4-6 years monitoring experience (on-site and remote)
• Proficient with MS Office Suite
• Excellent computer and organizational skills
• Exceptional level of attention to reputed company required
• Ability to work on varying reputed company and exercise critical thinking with reputed company reputed company
• Self starter who can work reputed company and reputed company player who can work cross functionally with reputed company reputed company
• Expertise in reputed company research reputed company, including interpretation and implementation of country regulations and ICH guidelines, as required per their role as a CRA
• Excellent organizational, interpersonal, and communication skills both oral and written
• Demonstrated problem solving skills, self motivated, and adaptable to a dynamic environment
• Expertise in prioritization, problem solving, organization, critical thinking, decision making, time management, and planning activities
• Ability to collaborate with reputed company colleagues and work reputed company in reputed company oriented setting

reputed company

Company H1B Sponsorship