Note: The job is a remote job and is open to candidates in USA. reputed company is an academic health system whose Division of Pulmonary, Critical Care, and Sleep Medicine conducts clinical and translational research and supports medical education and training. The Clinical Research Analyst 4 provides advanced regulatory operations, quality assurance, risk assessment, audit readiness, and portfolio management support for complex pulmonary clinical research studies, while guiding study teams and maintaining clinical research systems and documentation.
Responsibilities
- 40% - Clinical Research Regulatory Operations and Portfolio Leadership
- 30% - Clinical Operations Risk Assessment, CAPA, and Audit Readiness
- 20% - Regulatory Implementation, Study Team Guidance, and Operational Risk Support
- 10% - CTMS/eReg Tracking, Metrics, Reporting, and Professional Development
Skills
- Certification by the Society of Clinical Research Associates (SOCRA-CCRP) or the Association of Clinical Research Professionals (ACRP-CCRC/CCRA/CP), or equivalent, required within 1 year of hire if not already held
- Bachelor's degree in related area or equivalent experience or training
- Extensive experience in clinical research operations, regulatory coordination, clinical research quality, or human-subjects research administration supporting complex clinical trials or clinical research portfolios
- Experience independently managing regulatory workflows for clinical research studies, including IRB submissions, protocol amendments, continuing reviews, reportable events, regulatory correspondence, essential document maintenance, and study closeout activities
- Experience interpreting clinical research protocols, FDA regulations, ICH-GCP guidelines, IRB requirements, sponsor requirements, and institutional policies and applying them to complex study conduct issues
- Advanced knowledge of clinical research practices and philosophy, FDA regulations, ICH-GCP, IRB requirements, HIPAA, research privacy, sponsor requirements, and institutional policies applicable to human-subjects research
- Advanced analytical and critical thinking skills to interpret complex protocols, assess regulatory and operational risks, evaluate unusual study conduct or documentation issues, and recommend practical solutions
- Advanced communication and interpersonal skills to explain complex requirements, advise investigators, supervisors, coordinators, sponsors/CROs, IRB, and institutional partners, and provide functional guidance and training to study teams
- Advanced organizational and project management skills to work independently, set priorities, manage competing deadlines, maintain accurate regulatory records and trackers, and adapt to changing study, sponsor, institutional, and portfolio needs
- Proven ability to use and support clinical research systems and software, including electronic medical records, OnCore or other CTMS platforms, eReg/eTMF systems, EDC systems, and spreadsheet/reporting tools
- Advanced interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members. Works well with others to achieve common goals
- Human Subjects Protection Training (e.g., reputed company) prior to engaging in study activities
- Current certification in Good Clinical Practice (GCP)
- Institutional certifications and trainings as required, including but not limited to HIPAA, privacy, and information security
- Must maintain compliance with all additional institutional, regulatory, or sponsor-mandated certifications and training requirements as applicable at reputed company
- Experience assessing operational or regulatory risk, developing corrective and preventive action plans, and supporting audit, inspection, or monitoring response activities
- Experience providing functional guidance, training, or regulatory operations support to investigators, supervisors, clinical research coordinators, or cross-functional study teams
- Experience using clinical research systems and databases, such as electronic medical records, OnCore or other clinical trial management systems, eReg/eTMF or regulatory tracking systems, and electronic data capture systems
- Ability to support a high-volume clinical research portfolio with multiple active protocols, sponsors/CROs, amendments, monitoring findings, regulatory deadlines, and competing operational priorities
- Ability to develop or improve regulatory workflows, documentation standards, CAPA tools, audit-readiness processes, training materials, trackers, dashboards, and portfolio management tools
- Ability to serve as an advanced resource and role model for clinical research staff, maintain effective relationships with faculty and cross-functional partners, exercise discretion with sensitive info
