Regulatory Affairs Specialist

About Company:

Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders.  ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.

Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. 

Job Description:

The Regulatory Affairs Specialist is responsible for a variety of clinical research operations duties of a routine and technical nature in support of clinical trials. Completes all duties under the direction of the Director of Regulatory Affairs. Maintains accurate and confidential files and documentation of study protocols. In executing these position responsibilities, the Regulatory Coordinator is guided by Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) and company standard operating procedures and policies.

Responsibilities:

• Working knowledge of GCP/ICH guidelines, clinic SOPs and individual protocols
• Create and maintain electronic Investigator Site File per FDA/Sponsor requirements.
• Coordinate with site staff, vendors, and contract employees to obtain all related signatures, licensure, and necessary certifications required for regulatory compliance.
• Work closely with sponsors, CROs, and IRBs to facilitate timely turnaround of study documents.
• Track and maintain all study related documents.
• Complete IRB submissions to include initial submission, revisions to research, promptly reportable items, and study termination reports to meet all required timelines. 
• Track IRB submissions and approvals, study status and document expirations
• Maintain current study staff qualification documents in electronic repository, to include Curriculum Vitae reformatting and updates of investigator and sub-investigator supporting documents.
• Stay in constant communication with site staff regarding forthcoming IRB approvals to include protocols, consent forms, subject facing materials, and other related items.
• Request monitor access to electronic Investigator Site File
• Meet with sponsors, monitors, and auditors/inspectors during their visits and work to resolve regulatory issues raised during these visits.
• Review and respond to monitor questions regarding regulatory documents and help to ensure that all regulatory issues identified are resolved at the time of the monitors’ visits. 
• Maintain master list of all studies performed at site.
• Maintain record retrieval information for all study related documents.
• Prepare Study Documents for Long Term Storage and maintain record retrieval information for all archived documents.
• Train and coach other designated regulatory staff
• Maintain current training with applicable SOPs/WIs, GCP, etc.
• Comply with the confidentiality of research data.
• Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.

Skills and Qualifications:

• Education and experience

• 3 year of clinical research experience is preferred, preferably including Regulatory and IRB
• High School Diploma or its equivalent; College degree preferred.
• Regulatory Affairs Certification (RAC) preferred but not required.

• Requirements
  • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Knowledgeable in medical terminology 
  • Excellent communication skills (interpersonal, written, verbal) 
  • Excellent organizational and interpersonal skills
  • Attention to detail.
  • Strong computer skills, including knowledge of all components of Microsoft Office are required.