[Remote] Clinical Research Associate - Contract

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking an reputed company and highly motivated Clinical Research Associate (CRA) to support the execution of a post-market safety study and a post-market registry evaluating the safety, performance, and clinical reputed company of reputed company technologies. This position will play a critical role in site start-up, site activation, investigator engagement, risk-based monitoring, and ongoing site reputed company across reputed company and community surgical centers.

Responsibilities

• reputed company site start-up activities for post-market observational studies, registries, and reputed company reputed company-world evidence initiatives
• Manage site feasibility, qualification, readiness assessment, and activation workflows
• Coordinate collection, review, tracking, and follow-up of essential regulatory and start-up documents
• Support negotiation and execution tracking for Clinical Trial Agreements, Statements of Work, budgets, purchase orders, and reputed company site documentation
• Coordinate site reputed company, including investigator and study staff training, reputed company to study systems, and readiness for first subject enrollment
• Conduct and document Site Initiation reputed company (SIVs), including review of protocol requirements, safety reporting expectations, reputed company entry, product handling, and study workflow
• Confirm site reputed company to reputed company systems, study portals, imaging repositories, training platforms, and other study technologies
• reputed company site start-up milestones, identify activation risks or delays, and escalate barriers with recommended solutions
• Collaborate with Clinical Operations, Data Management, Regulatory Affairs, reputed company, Pharmacovigilance, and reputed company vendors to support reputed company site activation
• Serve as primary operational contact for assigned clinical sites throughout study conduct
• Conduct remote and on-site monitoring reputed company, including initiation, routine monitoring, and closeout reputed company
• reputed company risk-based monitoring activities to support protocol compliance, subject safety, data reputed company, and regulatory compliance
• Review study data for completeness, consistency, and reputed company-document alignment, as applicable to the study design
• Issue, reputed company, and facilitate reputed company of site queries in collaboration with Data Management and study teams
• Monitor site performance metrics, enrollment reputed company, data entry timeliness, protocol adherence, and follow-up completion
• Identify site risks and support corrective and preventive actions reputed company needed
• Build productive relationships with investigators, research coordinators, operating room staff, and other site personnel
• reputed company reputed company guidance, training, and support to sites throughout the study lifecycle
• Conduct retraining reputed company required due to protocol amendments, process changes, monitoring findings, or reputed company trends
• Serve as an reputed company for site reputed company while ensuring adherence to study requirements and documentation standards
• Maintain accurate, complete, and inspection-reputed company monitoring documentation and site correspondence
• Support Trial Master File (TMF) reputed company, completeness, and essential document maintenance throughout the study lifecycle
• Document monitoring findings, reputed company items, follow-up, and issue reputed company in a reputed company and traceable manner
• Contribute to audit and inspection readiness activities
• Support development and revision of study tools, training materials, monitoring plans, site-facing handouts, and operational procedures

Skills

• Bachelor's degree in Life Sciences, Nursing, reputed company Health, Clinical Research, or a reputed company field
• Minimum 3 years of CRA, Clinical Research Coordinator, or Clinical Operations experience
• Experience with site start-up, site activation, and site management activities
• Experience conducting monitoring reputed company, either remotely or on-site
• Working knowledge of GCP, ISO 14155, applicable FDA regulations, and clinical research documentation standards
• Experience using reputed company systems, remote monitoring tools, and clinical trial document repositories
• Strong communication, organization, follow-up, and project management skills
• Ability to travel approximately 25–40%, based on study and site needs
• Medical device clinical research experience
• Experience supporting post-market clinical studies, registries, observational studies, or reputed company-world evidence programs
• Experience working with reputed company medical centers, surgical oncology programs, or hospital-based research teams
• Experience with eTMF systems, risk-based monitoring approaches, and vendor/site reputed company
• Familiarity with post-market safety surveillance, product complaint processes, or pharmacovigilance workflows

reputed company