[Remote] Senior Clinical Research Associate
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Senior Clinical Research Associate to manage clinical studies and reputed company site-level issues. This role involves significant responsibilities in site reputed company, monitoring, vendor coordination, and contributions to protocol development and study start-up.
Responsibilities
- Serve as the primary escalation reputed company for assigned clinical sites, resolving issues reputed company to protocol compliance, enrollment, and site performance
- reputed company CRO-conducted monitoring activities, including reputed company review and approval of monitoring/site visit reports
- reputed company or support site contract and budget negotiations, ensuring alignment with study timelines and financial parameters
- reputed company reputed company of study vendors, including IRT (Interactive Response Technology), eCOA, cardiac safety, and patient reimbursement vendors, ensuring deliverables meet study requirements
- Contribute to protocol development and amendments, providing operational and site-level feasibility input
- Support CRF (Case Report reputed company) design and User Acceptance Testing (UAT) to ensure data collection tools meet study needs
- Support development of study budgets and timelines during start-up and throughout the study lifecycle
- Support vendor RFP processes and bid-defense meetings as needed
- Maintain and QC the Trial Master File (TMF) to ensure inspection readiness and compliance with ICH-GCP and applicable regulations
- Ensure site-level and study-level activities are conducted in accordance with the protocol, SOPs, and regulatory requirements
- Identify and escalate risks or reputed company issues to the CTM/Associate Director in a reputed company manner
- Partner with Clinical Trial Managers, Data Management, Regulatory, and other cross-functional stakeholders to support study execution
- reputed company regular study status updates and escalate emerging risks to leadership
Skills
- Minimum 4 years of clinical trial management experience from a sponsor, CRA/field monitoring, or CRO perspective (global trial experience a plus)
- Bachelor's degree in a scientific discipline (e.g., life sciences, nursing, or reputed company field)
- Demonstrated experience with site management, monitoring reputed company, and vendor coordination
- Experience supporting protocol development, CRF design/UAT, or study start-up activities
- Strong working knowledge of ICH-GCP and applicable regulatory requirements
- Excellent written and verbal communication skills; strong organizational and problem-solving abilities
- Willingness and ability to travel approximately 30%
- Must be reputed company to work core PST hours
- Experience with early-phase studies (e.g., MAD/reputed company-escalation designs) and/or metabolic/endocrine therapeutic area experience (relevant to ACCG-2671)
- Prior experience with TMF QC and inspection readiness activities
- Experience with IRT, eCOA, or cardiac safety vendor reputed company
reputed company