Clinical Research Regulatory Specialist

The Clinical Research Regulatory Specialist key role is to ensure the research program meets compliance with local, state, and federal regulations. In addition the Specialist works with Investigators, research administration, clinical lead, and sponsors to coordinate and conduct study start up to ensure efficient and successful adoption of new research studies. The incumbent is relied upon to deliver key results, provide guidance to team members through expertise and experience, and make informed, business-driven decisions in collaboration with the Clinical Research Manager.

Essential Job Functions

• Develops, implements, and administers policies, procedures, and compliance programs for clinical research practices, ensuring adherence to local, national, and international regulations and best practices.
• Ensure safety monitoring, and compliance with all protocol procedures, including Institutional Review Board (IRB) submissions, adverse event reporting, and regulatory documentation.
• Oversees regulatory submissions including initial IRB application, continued review, serious adverse events, unanticipated problems and study closure.
• Provides expertise regarding interpretation and application of government regulations and laws, and all operational processes related to human subject protections.
• Creates, maintains, disseminates, and assists in training staff on applicable policies and procedures and study specific training.
• Responsible for ensuring all training requirements are met and current (i.e., GCP, HSP, Conflict of Interest, IATA, Equipment calibrations, CLIA, CAP certificates).
• Ensures accurate data collection, analysis, and reporting for clinical trials, supporting excellent data integrity, protocol adherence, and sponsor satisfaction.
• Communicates and collaborates with study team, including internal and external parties, sponsors, CRO, investigators, and study participants.
• Maintains, organizes, and ensures completeness for both physical and electronic Investigator Site File and patient charts in real-time, in collaboration with the Research Nurses and/or Clinical Coordinators.
• Conducts regular quality control checks including designing and applying audit tools.
• Responsible for the research quality assurance program to ensure continuous compliance and audit readiness.
• Stays current with new regulations and updates policies and procedures.
• Leads internal and external audits including regular monitor visits.
• Communicates knowledge of current and updated regulatory requirements and guidelines for implementation.
• Creates and maintains systems for efficient study start up through communication with sponsor, stakeholders, and study team.
• Performs other related duties as assigned by management, for which appropriate training will be provided, to support departmental objectives and organizational success.
• Regular, predictable, and reliable attendance is required to perform the essential duties of this position and to meet operational deadlines, maintain team coverage, and complete time-sensitive work that depends on in-person coordination and access to on-site systems/resources. Employees must report to work as scheduled, be punctual, and remain at work for assigned hours. For roles requiring coordination with patients, providers, and/or teams, consistent availability during scheduled hours is necessary to maintain safe and effective operations, continuity of work, and timely completion of job responsibilities. Employees must follow established call-out and scheduling procedures and provide timely notice of unscheduled absences when feasible. OSG will comply with applicable federal and Oregon laws regarding protected leave and reasonable accommodations.
• When remote work is approved, the employee must be reliably accessible via agreed communication channels and able to perform duties effectively during the scheduled workday.

Required Qualifications

• Bachelors degree in health care or science related field
• Minimum of 5 year experience in research
• Experience working with Institutional Review Boards
• Proven knowledge of local and federal rules and regulations
• Experience developing and implementing SOPs
• Experience working with complex clinical trials and clinical research program
• Experience with FDA audits
• Strong analytical, reporting, and evaluation skills
• GCP/HSP certification
• Attention to details

Preferred Qualifications

• Experience with oncology clinical trials
• Experience as a research coordinator
• ACRP or SOCRA Certified