Clinical Research Associate (CRA) III

{
  "added": [
    "The Role The Clinical Research Associate III (CRA III) will be responsible for the day-to-day operations associated with the execution of clinical trials and monitoring the clinical trial sites to ensure they are complying to the applicable study protocol, Standard Operating Procedures (SOPs), CVRx requirements, Good Clinical Practice (GCP), and the applicable regulatory requirement(s).",
    "The CRA III will work closely with the Clinical Study Manager to ensure site day-to-day operations and monitoring is executed to meet project deliverables.",
    "CRA III is expected to work from the CVRx office, or at the sites when monitoring.",
    "KEY DUTIES AND RESPONSIBILITIES Develops and maintains successful working relationships with study sites and serves as the primary point of contact.",
    "Assists in preparation of study materials and training of investigators and site staff Supports Clinical Centers in the execution of site IRB or ethics committee submissions Responsible for the collection and tracking of required regulatory documents from Clinical Centers Coordinates and conducts monitoring (as directed by the monitoring plan) at participating centers to ensure compliance with the protocol and applicable regulations, as well as the timely receipt of accurate data and other required study documents Prepares and submits high-quality monitoring reports per study-specific requirements Evaluate site performance through analysis of enrollment trends, data quality metrics, protocol deviations, product accountability, and patient safety parameters Support sites in AE/SAE identification, documentation, and reporting Verify timely submission of required safety documentation, device complaint forms, and follow-up querie s Drive proactive risk identification at the site level and support the execution of risk-mitigation plans Source verifies clinical data/information and oversees data correction to match source Maintains Clinical Study files Manages device accountability at site (if applicable) Processes payments to sites, vendors, and consultants Reviews clinical data/information and oversees data correction Reviews center activation documentation Work closely with Clinical Project Managers, Data Management, Safety, Regulatory, Quality, and Training to ensure end-to-end study execution Provide operational input on protocol development, CRFs, risk assessments (RACT), monitoring plans, investigational brochures, and essential document requirements Collaborate in Trial Master File ( TMF ) quality checks to ensur e site-level documentation is complete, audit-ready, and compliant Contribute to process improvement initiatives, QMS updates, and clinical operations optimization Assist management in metrics reporting, monitoring dashboards, and early risk detection through data analytics Participate in vendor oversight (central labs, imaging, core labs) to ensure site compliance (if applicable) Assists in training new Clinical Research Associates Assists with successful conduct of assigned studies.",
    "This includes interfacing with representatives from key functional groups including Regulatory Affairs and Quality Assurance, Research & Development, U.S.",
    "Market Development, Commercial Development and Clinical Research Organizations Provides mentoring regarding site monitoring to internal team Completes special projects and perform s job-related duties as assigned REQUIRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE Bachelor’s degree 5+ years experience directly supporting clinical research or similar experience in a medical/scientific area 2+ years experience in monitoring clinical trial sites Knowledge of GCP’s and regulatory compliance guidelines for clinical trials Knowledge of medical terminology High attention to detail and accuracy Able to manage multiple tasks and operate independently Operates in an efficient and expedient manner High ethical standards and integrity Strong team player with experience working cross-functionally and maintaining high-performance standards Comfortable in a small company and thrives in a high-growth environment Advanced written and oral communications skills Good problem-solving skills Adaptable, resourceful, and comfortable navigating change Entrepreneurial approach PREFERRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE Advanced degree in a related field is preferred WORKING CONDITIONS AND REQUIRED PHYSICAL EFFORT Normal office conditions and a reliable internet connection when working in a home office Must be able to sit/stand/walk 8 hours per day Position requires up to 40% travel May be required to be fully vaccinated against the COVID-19 virus and other diseases CVRx is unable to provide employment visa sponsorship for this position.",
    "Salary range for U.S locations (USD): 127,000 - 142,000 per year."
  ],
  "removed": [
    "The Role The Clinical Research Associate (CRA) II performs the day -to-day operations associated with the execution of clinical trials and is responsible for the direct contact with assigned clinical investigative sites.",
    "The CRA II will coordinate site activities from site start-up to site closure as needed.",
    "The CRA II will ensure the overall quality of the clinical sites by reviewing study data and managing site adherence to the protocol, Good Clinical Practice (GCP), and all applicable regulations.",
    "The CRA II will work closely with the other CRAs on the clinical team and project managers to ensure the sites maintain compliance .",
    "KEY DUTIES AND RESPONSIBILITIES Proactively maintains timelines for assigned or requested deliverables.",
    "Develops and maintains successful working relationships with study sites and CVRx field staff Assists in preparation of study materials and training of investigators and research site staff Becomes proficient with all study databases, systems and company quality management system Reviews and verifies clinical data/information and oversees data correction to match source Acts a site manager and monitor to assigned sites as applicable per study requirements Processes payments to sites, vendors, and consultants .",
    "Supports the Clinical Project Manager with study finance activities and tracking Supports Clinical Centers in the execution of site Institutional Review Board (IRB) or ethics committee (EC) submissions Responsible for the collection, tracking, and maintaining required study and regulatory documents from clinical centers through all phases of assigned projects Prepares study materials and trains investigators and site staff Responsible for shipment of study-related materials as applicable Coordinates and conducts monitoring (as directed by the monitoring plan) at participating centers to ensure compliance with protocol, regulations, and the timely receipt of accurate data / other required study documents Reviews and verifies clinical data/information and oversees data correction to match source Reviews monitoring reports Manages device accountability at site (if applicable) Provides input to study budgets and project plan Contributes to maintaining oversight of activities conducted by Contract Research Organizations (CRO’s) or other contractors on behalf of CVRx (if applicable) Assists in training or mentorship of new Clinical Research Associates Completes special projects and performs job-related duties as assigned REQUIRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE Bachelor’s degree or advanced degree in science or a related field, or equivalent work experience 2-4 years experience directly supporting clinical research or similar experience in a medical/scientific area Knowledge of medical terminology Experience with GCP’s and regulatory compliance guidelines for clinical trials High attention to detail and accuracy Ability to manage multiple tasks and operate independently Operates in an efficient and expedient manner High ethical standards and integrity Experience working on cross-functional teams Comfortable in a small company and thrives in a high-growth environment Advanced written and oral communications skills Good problem-solving skills Adaptable and embraces change Creative and resourceful Team player with high performance standards Entrepreneurial approach PREFERRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE Advanced degree in a related field WORKING CONDITIONS AND REQUIRED PHYSICAL EFFORT Normal office conditions and a reliable internet connection when working in a home office Must be able to sit/stand/walk 8 or more hours per day Position requires up to 40% travel May be required to be fully vaccinated against the COVID-19 virus and other diseases.",
    "CVRx is unable to provide employment visa sponsorship for this position.",
    "Salary range for U.S locations (USD): 85,000 - 105,000 per year."
  ]
}