Sr Clin Research Reg Supt Spec

Responsibilities

• Represents the Research Base to all regulatory bodies.
• Ensures the work of over 1000 clinical research professionals is complete, accurate, and done in a timely manner as defined by research protocols, SOPs, and federal requirements.
• Oversees all regulatory submissions and regulatory compliance.
• Acts as primary regulatory liaison with agencies such as IRB, government agencies, and Sponsors.
• Works closely with Research Base cross-functional teams in preparation of study documents for submissions of new protocols, study protocol amendments, annual continuing reviews of approved studies, as well as unanticipated events to the Sponsor and IRB.
• Performs final edits and proofreading of protocol submission package documents.
• Prepares and sends protocol documents for submission.
• Coordinates, tracks, and monitors information regarding protocol submissions and documents required for the NCORP sites.
• Reviews regulatory and other site records such as Federal Wide assurance and site level approvals to ensure adherence to Research Base SOPs, the approved clinical research protocol, and to all applicable federal regulations.
• Develops and maintains standard operating procedures in collaboration with Program Managers, Administrative leadership, and MPIs of the Research Base.
• Updates and maintains ClinicaTrials.gov records.
• Updates and maintains conflict of interest records.
• Develops, updates, and maintains protocol templates.
• Acts as regulatory representative for NCORP Research Base as primary point of contact for over 800 community sites across approximately 30 NCORP community partner programs.
• Participates in meetings with regulatory/audit team, project teams, and Institutional Review Board meetings as the regulatory liaison.
• Disseminates updates from pertinent meetings to multiple teams within the Research Base and the Division (as needed).
• Oversees, organizes, tracks rostering and membership requests.
• Performs other project coordination activities as directed by the Program Manager, Administrative leadership, or MPIs of the URCC NCORP Research Base.
• Aids or leads sections for URCC NCORP progress report reporting and grant submissions for concepts and the overall URCC NCORP Research Base.
• Assists or leads sections for URCC NCORP progress report reporting and grant submissions for concepts and the overall URCC NCORP Research Base.

Requirements

• Bachelor's degree and 3 years of relevant experience required.
• Equivalent combination of education and experience may be considered.

Qualifications

• Fully adheres to applicable safety and/or infection control standards required.
• Ability to mentor and provide training to junior members of the team preferred.
• Possesses a high degree of self-motivation preferred.
• Recognized ability to function independently preferred.
• Proficient in managing multiple and competing priorities/demands preferred.
• Detailed-oriented in record keeping and research documentation preferred.
• Understands and follows data integrity standards and processes preferred.
• Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation preferred.
• Strong interpersonal, communication, and organizational skills preferred.
• Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients) preferred.
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet preferred.

Skills

• Certification in Clinical Research (SOCRA) within 1 year required.
• Certified Clinical Research Professional (CCRP) by the Association of Clinical Research Professionals (ACRP) within 1 year required.
• Certified in Healthcare Research Compliance (CHRC) within 1 year required.