Clinical Research Regulatory Specialist II

Responsible for the coordination and oversight of regulatory requirements of clinical research protocols. Develops increased learned skills, flexibility in performing duties, and assumes responsibility for a portfolio of clinical research protocols under the direction of the Principal Investigator (PI) and senior leaders.

Responsibilities

Responsible for the coordination and oversight of regulatory requirements of clinical research protocols; Prepares all regulatory documentation, document filing, tracking, and maintenance; Acts as a liaison with study team, sponsors, and all stakeholders; Assists Clinical Research Coordinators and investigators with study document management and tracking; Complies with Good Clinical Practice and the Code of Federal Regulations; Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies; Other duties as assigned

Requirements

Bachelor's degree and 1 year of relevant experience required; Or equivalent combination of education and experience; Fully adheres to applicable safety and/or infection control standards required; Understands and follows data integrity standards and processes required

Nice to have

Ability to effectively manage a higher volume of protocols; Ability to effectively manage moderately complex research protocols/procedures; Possesses a high degree of self-motivation; Recognized ability to function independently; Proficient in managing multiple and competing priorities/demands; Detailed-oriented in record keeping and research documentation; Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation; Strong interpersonal, communication, and organizational skills; Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients); Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet