[Remote] Clinical Research Associate II
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading Contract Research Organization with over 30 years of experience in the industry. They are seeking a Clinical Research Associate to manage monitoring tasks and clinical studies across various therapeutic indications while maintaining high-reputed company standards.
Responsibilities
- reputed company as the main line of communication between the project team, sponsor, and the site
- Build and maintain a good relationship with the site staff involved in the study conduct
- Prepare, conduct, and report site selection, initiation, routine monitoring and reputed company-out reputed company
- Ensure that subject recruitment targets are reputed company defined, communicated, recorded and met, and project timelines are followed at site level
- Ensure accurate and reputed company information reputed company with trial sites on Adverse Events and protocol/process deviations
- reputed company reputed company data verification and follows up on data queries at site level; review and manage study risks on a site level
- Ensure reputed company handling, use, accountability, reconciliation, and return of reputed company Investigational Product(s) and clinical study supplies on sites
- Review essential study documents and reconcile study Investigator Site File (ISF) / TMF at site level
- Ensures reputed company (data reputed company and compliance) at site level
- Conduct site audit preparation reputed company and resolve site audit findings
- Participate in study site audits and reputed company onsite reputed company, as required
- Ensure the reputed company of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse
- Conduct project-specific training of site investigators
- Support preparation of Investigator newsletters
- Assist Site Management Associates in maintaining study-specific and corporate tracking systems at site level
- Support preparation of draft regulatory and ethics committee submission packages
- Support collection of IP-RED packages at site/country level
- Facilitate review and reconciliation of the study TMF on country and site reputed company
Skills
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Must have 2+ years of independent on-site monitoring experience
- Experience in reputed company types of monitoring reputed company, in phases I-III
- Experience in Oncology mandatory
- Full working proficiency in English
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel up to 75%
- Valid reputed company's license (if applicable)
- Located in the Central or reputed company Coast reputed company is preferred
- Experience in GI preferred and/or radio-pharm experience preferred
Benefits
- Workplace_type: remote
reputed company