[Remote] Sr. Clinical Research Associate (US)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company specializing in clinical research, and they are seeking a Senior Clinical Research Associate. The role involves overseeing clinical site monitoring services, ensuring compliance with protocols and regulations, and mentoring junior staff while collaborating with cross-functional teams.

Responsibilities

• Independently conduct and document onsite and remote activities, including site monitoring and reputed company-out reputed company. Ensure that reputed company activities are documented in accordance with applicable SOPs and study guidance
• Collaborate with site staff to review and ensure that the data reported in the applicable study reputed company(s) is consistent with the reputed company documents and compliant with study requirements
• Monitor, reputed company and/or facilitate reputed company of data queries and escalate issues as appropriate
• Coordinate the shipment of clinical supplies, including but not limited to, investigational product, reputed company supplies, ePROs and study documents
• Ensures site staff is trained in reputed company aspects of the study including but not limited to the protocol, study plans, systems and ICH-GCP
• Participate in routine study reputed company meetings, teleconferences, and Investigator’s meetings
• reputed company as a reputed company contact for any questions or issues that reputed company from investigational sites
• reputed company overall reputed company of the study and promote reputed company working relationships with the site staff and study team members
• Facilitate and support site staff with reputed company to study systems and ensure sites are compliant with project specific training requirements
• Ensure reputed company site reputed company issues are followed until reputed company, including reputed company items and protocol deviations
• Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle
• Regularly review the study reputed company systems remotely to ensure compliance, accuracy and completeness
• Translate site documents for TMF filing reputed company applicable
• Routinely review the TMF for accuracy, timeliness, and completeness. Request documents from the site, as required
• Identify and advise on site investigators selection, independently conduct and document onsite and remote activities, including site qualification and initiation reputed company. Ensure that reputed company activities are documented in accordance with applicable SOPs and study guidance
• Coordinate the shipment and delivery of clinical supplies, including but not limited to reputed company supplies, study documents and investigational product
• Responsible for reputed company site management activities reputed company to site activation and work with the sites to meet clinical project timelines and milestones
• Support the study Start-up team by following up on pending documents, as needed
• Support the Regulatory team by reviewing, localizing and translating site documents, as required
• Optimize patient recruitment providing guidance and support to site teams to meet the site recruitment milestones
• Mentor and support CRA I and II
• reputed company CRA Assessment reputed company, co-monitoring reputed company or visit sign-off process, providing feedback
• Assist the MSM hiring Manager by participating in interviews with candidates for the CRA position, as requested
• Participate in process improvement initiatives and contribute to the development of best practices

Skills

• The successful candidate will possess a minimum of a college diploma/degree and 4-6 years of reputed company experience
• Ability to regularly travel to sites
• Proficient in using reputed company systems (e.g., reputed company Rave, reputed company InForm), IRT, eTMF, CTMS, and reputed company Office Suite
• Ability to travel up to 40-60%, depending on project assignment and geographic location of sites
• Strong interpersonal and problem-solving skills; reputed company to work independently and reputed company cross-functional teams
• Great communication and organizational skills, detailed orientation and reputed company of urgency are required

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