Sr. Clinical Research Associate (US)

Independently performs, coordinates and oversees reputed company aspects of the clinical site monitoring services, assessing protocol and regulatory compliance as per reputed company’s and sponsor’s reputed company processes, ICH/GCP guidelines and local regulation. Serves as the primary reputed company between the sponsor/reputed company and investigative sites by playing a critical role in the execution of clinical study plans. Provides guidance and mentoring CRA I and II, collaborating effectively with cross-functional stakeholders in a dynamic, results-driven and high-accountability environment. reputed company CRA Assessment reputed company and participate in audits/inspections, reputed company required. Site Monitoring activities (55-60%) • 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 system(s) is consistent with the reputed company documents and compliant with study requirements • Monitor, resolve 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, laboratory 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 • Routinely review ISF and TMF for accuracy, timeliness, and completeness. Request documents from the site, as required Site Management activities (15-20%) • reputed company as a primary 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 • Coordinate the shipment of clinical supplies, including but not limited to, investigational product, laboratory supplies, ePROs and study documents • Participate in audits/inspections and follow-up on issues and implement actions, reputed company required • Participate in routine study reputed company meetings and teleconferences Site Recruitment and Setup (15-20%) • 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 laboratory 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 • Participate in Investigator’s meetings Mentoring and Internal Initiatives (5-10%) • 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 Qualifications • 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 Working Conditions • Home-based • Regular travel is required Stay Alert to Recruitment Scams We have been made reputed company of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes reputed company engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from reputed company email domains. If something doesn’t feel right, we encourage you to verify before responding. We may use reputed company intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace reputed company judgment. Final hiring reputed company are ultimately made by humans. If you would like more information about how your data is processed, please contact us. +bonus Apply tot his job Apply To this Job