University of Rochester IDRC Requlatory Specialist - 229276 in Rochester, New York
IDRC Requlatory Specialist Job ID 229276Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening
Full Time 40 hours Grade 053 Medicine M&D-Infect Dis UnitSchedule
8 AM-4:30 PMResponsibilities
This position is to join a dynamic and very busy research clinic with multiple contracts with the NIH and pharmaceutical companies. This individual will serve as a regulatory specialist for both NIH and industry sponsored projects related to research conducted by the Infectious Diseases Research clinic with an emphasis on project for the University of Rochester Vaccine and Treatment Evaluation Unit (UR VTEU) a 7 year NIH-funded grant to perform clinical studies as part of the large NIH network called the Infectious Diseases Clinical Research Consortium (IDCRC). The individual will be responsible for addressing all regulatory requirements for conduct of studies under Good Clinical Practice and will assist the IDRC quality manager in audits of study processes and activities. Exceptional organizational skills, attention to detail and experience with research regulatory bodies and principles will be required.
Works with senior Human Research Subjects Coordinators on all aspects of protocol submission for research projects including: • Prepares and submits all necessary documents to the Institutional Review Board (IRB) and ancillary committees. • Assists with timely submission of IRB applications for protocol revisions or amendments, continuing reviews, reportable new information (RNI) administrative changes, changes in subject population, funding, recruitment, procedures, site changes, changes in the informed consent, or dual enrollment to additional studies for IRB approved protocols as required by the federal regulations and internal policy.• Prepares and submits all regulatory documents to sponsor and/or contract research organization (CRO) such as 1572, financial disclosure forms, CV• Maintains electronic and hard copy files of regulatory documents including a study specific regulatory binder and department “shared drive” regulatory files.
Updating and maintenance of Oncore. Updating Clinical Trials Management System (CTMS) as needed with location profile information (CVs, medical licensures, laboratory accreditations), IRB status, consent form versions (protocol/consent form evolution), and safety information.stablishes internal auditing procedures to ensure clean, FDA ready research charts and database. Performs internal quality assurance audits of research activities involving human subjects to ensure protocol adherence, timely data entry and query resolution. Work with the senior HRSC to coordinate monitoring site visits and audits of clinical trials. Reviews and confirms subject eligibility and regulatory compliance for enrollment. Submits eligibility exceptions to the IRB. Works with clinical coordinator and study lead to ensure Adverse Events and SAE are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary.
Ensures maintenance of up-to-date regulatory records and compliance with industry or NIH guidelines. Provide guidance and assistance to investigators in preparing Investigational New Drug applications (INDs) and Investigational Device Exemptions (IDEs) to the Food & Drug Administration (FDA). Ensures all regulatory files and other study specific material are prepared for off-site storage in accordance with FDA and other applicable regulatory guidelines. Follows up with sponsor for transfer or disposal of study materials.
Demonstrates expertise with regulatory procedures, HIPAA compliance, and Federal and local regulations for research on human subjects. Provides guidance to investigators and coordinators regarding Good Clinical Practices (GCPs) in research involving human subjects. Implements protocol specific and GCP training programs for staff members and clinical staff. Provides training to junior and new staff on regulatory processes and procedures.
Attends investigators meetings and site initiation visits regarding clinical trials and disseminates information to clinical staff. Serves as the resource for detailed information on assigned protocols and other investigational research activities.
Other duties as assigned.
Bachelor's degree with major course work in an appropriate health, social or technical field.
2-3 years of related experience or an equivalent combination of education and experience.
Excellent organizational and communication skills are required. Ability to work with a high level of confidentiality is imperative. Expertise using computer assisted office programs is essential. Ability to think creatively and work autonomously is a plus. Extensive knowledge of Microsoft Office, especially use of Excel.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled