Clinical Trials Regulatory Specialist III- Winship Cancer Institute

Clinical Trials Regulatory Specialist

Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community.

About Winship Cancer Institute of Emory University

Dedicated to discovering cures for cancer and inspiring hope, Winship Cancer Institute of Emory University is Georgia's only National Cancer Institute-designated Comprehensive Cancer Center, a prestigious distinction given to the top tier of cancer centers nationwide for making breakthroughs against cancer. Winship is researching, developing, teaching, and providing novel and highly effective ways to prevent, detect, diagnose, treat, and survive cancer. Cancer care at Winship includes leading cancer specialists collaborating across disciplines to tailor treatment plans to each patient's needs and type of cancer; innovative therapies and clinical trials; comprehensive patient and family support services; and a personalized care experience aimed at easing the burden of cancer. Winship is Where Science Becomes Hope®. For more information, visit winshipcancer.emory.edu.

Winship is seeking qualified candidates for the Clinical Trials Regulatory Specialist position. Position details are as follows:

The Clinical Research Coordinator II handles administrative activities generally associated with the conduct of clinical trials.

Key responsibilities:

• Manages research project databases, develops flow sheets and other study related documents, and completes source documents/case report forms.
• Provides guidance to less experienced staff.
• Interfaces with research participants, determines eligibility and consents study participants according to protocol.
• Approves orders for supplies and equipment maintenance.
• Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires.
• Supervises collection of study specimens and processing.
• Establishes case packages for study procedures, monitors scheduling of procedures and charges, coordinates other services as needed.
• Ensures compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings with sponsors.
• Prepares regulatory submissions.
• With appropriate credentialing and training may perform phlebotomy or diagnostics.
• Performs related approved responsibilities as required.

Minimum qualifications:

• High School Diploma or GED and five years of clinical research experience.
• Or two years of college in a scientific, health related, or business administration program and three years clinical research experience.
• Or a licensed as a practical nurse (LPN) and two years clinical research experience.
• Or a Bachelor's degree in a scientific, health related, or business administration related program and one year of clinical research experience.
• Or a Master's degree, MD or PhD in a scientific, health related or business administration program.

This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of Clinical Researcher.

Key responsibilities:

• The Regulatory Specialist III is an advanced level position supporting regulatory affairs in clinical trials research.
• Employees in this job class support all trial complexities (basic to multiphase) and manage the study activation process.
• Serves as the internal project manager for assigned specific oncology disease group(s), providing the group with timely updates on the status of submissions and regulatory guidance on study development.
• Liaison between the sponsor, the investigator, Winship, Emory IRBs, external IRBs and internal departments/staff.
• Incumbents in this job class may also supervise/train Specialist Is and IIs, lead project specific task forces, and/or serve as project/process improvement leads.
• Duties include:
• Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
• In concert with IND Sponsors, prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
• Responsible for 35+ trial load per year of NCTN, industry and investigator-initiated trials.
• Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations.
• Reviews processes involving regulatory documentation, including but not limited to NCTN/NCI informed consent review, to assure appropriate timelines are followed.
• Maintain study regulatory binders and electronic files in accordance with institutional and sponsor requirements.
• Coordinate protocol activation/maintenance process and communicates to allow for enrollment to start and maintain once regulatory documents (e.g. DSMC review) are in place.
• Disseminates information and coordinates or conducts training.
• Researches and analyzes problems and takes a leadership role in resolving.
• Lead study start-up/maintenance: prepare and submit all required regulatory documents for new/current study applications and successfully open/close studies from inception to accrual.
• Participates in the development and implementation of standard operating procedures, development and revision of regulatory orientation plans, and orientation and mentorship of newly hired staff.
• Actively participates in designated committees within the unit and Emory University.
• Direct the clinical team to ensure all facets of each protocol are compliant and fully covered.
• Perform internal audit and quality assurance checks on regulatory documents.
• Prepare, track and maintain all correspondence and regulatory documentation required by the IRB, FDA, IND Sponsors, and other institutional and federal oversight committees, including drafting and reviewing content as appropriate.
• Process IND safety reports, maintain documentation of PI review and submit safety reports to the IRB as appropriate.
• Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations.
• Completes submission applications, and other required documentation, prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities.
• Serves as lead contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, federal, pharmaceutical).
• Completes protocol renewal applications and amendment applications.
• Attends research team meetings to report on regulatory updates and issues. Responsible for administrative duties corresponding to budgets and contracts.
• Single patient/compassionate use submission and maintenance across disease types.
• Performs related responsibilities as required.

Minimum qualifications:

• Bachelor's degree and five years of experience in a research environment, or an equivalent combination of experience, education and training.
• Knowledge of IRB processes, federal research regulations and a basic understanding of funding programs and clinical research practices.
• Must obtain all required training courses within one month of hiring date.
• Must possess an applicable research certification within 2 years of hire (i.e. ACRP, SOCRA, RAC etc.).