The Clinical Research Regulatory Specialist is responsible and accountable for ensuring all documentation related to research protocols are completed and submitted accordingly. The regulatory staff ensures smooth coordination of research activities with clinical research staff, sponsors, CROs, IRBs, and other internal stakeholders. This position provides regulatory oversight, organization, and coordination of research involving physicians and clinicians, as well as other involved departments. The ideal candidate will possess strong written and verbal communication skills, attention to detail, ability to meet multiple changing deadlines, and the ability to work independently. This position will be a combination of office-based and remote.  

Required Skills:

• Ability to plan, organize, set priorities, and work in a fast-paced environment and handle multiple projects simultaneously and efficiently with precision.
• Strong proficiency in Microsoft Office programs (Outlook, Word, Excel, Adobe) and web applications
• Ability to Create and maintain controls on documents.
• Ability to use software to develop organized information sources and to provide a variety of reports.
• Ability to type proficiently (35+ wpm)
• Must possess excellent verbal and written communication skills.
• Ability to work well independently as well as with co-workers, peers, supervisors, and external sources.
• Ability to adapt to changes in responsibilities and workloads.
• Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic.
• Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, subject matters, and other confidential information.
• Demonstrated capacity to problem solve, think critically and creatively, and provide support through a consultative role.
• Ability to communicate effectively when reading and writing e-mail, letters, and other reports.
• Knowledge and understanding of human research policies, regulations, procedures, and standards according to FDA, ICH, GCP guidelines are preferred.
• Bachelor’s Degree in healthcare or science-related field with prior regulatory specialist experience is preferred. An equivalent combination of education and experience may be allowed.

Essential Job Duties:

• Updates Clinical Trials Management System (CTMS) as needed with essential profile information (CVs, medical licensures, laboratory accreditations), IRB status, consent form versions (protocol/consent form evolution), and safety information.
• Prepares regulatory documentation packets and creates all FDA 1572 Forms for IND filings. Distributes financial disclosure forms, protocol signature pages, and FDA 1572 forms to obtain investigator and staff signatures. Ensures all necessary forms are submitted to the Sponsor company to activate protocols.
• Posts regulatory documents including protocols, amendments, consent forms, SAE forms, etc. on the CTMS.
• Submit initial applications for study approval to the IRB. Submit continuing review reports, closeout reports, and other materials to the IRB for approval and process accordingly.
• Prepares, maintains, updates, and audits study-specific regulatory files, IRB files per FDA guidelines and resolves queries, as necessary.
• Distributes IRB documentation and post IRB meeting information to study sponsors, research, and clinical staff accordingly.
• Communicate effectively with the company’s coordinators, marketing staff, and management; pharmaceutical companies; IRBs; study sponsors, and other team members.
• Advise others on regulatory and compliance matters.
• Identify and interpret relevant regulatory guidelines.
• May perform other duties not specifically listed in this job description as assigned by their immediate supervisor.

‍

‍