JOB SUMMARY

The Research Regulatory Associate II under limited supervision, works closely with our Clinical Research staff to provide excellent regulatory oversight for our clinical trials under the supervision of the Clinical Research Manager.

DUTIES AND ESSENTIAL JOB FUNCTIONS

• Develops and implements compliance program components including protocol and consent form review, record keeping, monthly and annual reporting, program evaluation and other compliance issues that meet the regulations and the institution's policies and procedures.
• Facilitate and coordinate the timely and accurate submission of regulatory documents (such as but not limited to: FDA form 1572, protocol signature page, delegation of authority logs, etc) and IRB submissions by collaborating with research nurses, clinical research coordinators, and investigators in the preparation of regulatory documents
• Collaborate effectively with Principal Investigators (PIs), research personnel, and the Institutional Review Board (IRB) to ensure thorough protocol reviews, approvals, and amendments.
• Manage the internal review process for new studies and act as the primary contact for the completion and collection of the regulatory affairs questionnaire for Sponsors/Contract Research Organizations (CRO).
• Maintains site compliance with standard operating procedures, sponsor/CRO requirements, Food and Drug Administration (FDA) regulations, ICH guidelines, and good clinical practices pertaining to the conduct of clinical pharmaceutical and device protocols.
• Ensures prior to sending to the IRB that all documents are complete and that the submission packet meets the IRB's submission requirements.
• Maintains subject and document confidentiality, understands, and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration, good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures.
• Communicates and facilitates responses to queries by the IRB, Sponsor, and other committees.

• Coordinates the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state, and local agencies governing biomedical research.
• Maintains audit ready status with required logs within the regulatory binder(s), assists in and manages the archival of clinical trial documents/records. Tracks workload and status of pending protocols and associated supporting documents to provide efficient customer service to the Research team.
• Interacts with internal and external personnel, including but not limited to physicians, nurses, research staff members, administration staff, industry sponsor representatives, IRBs, central laboratory/imaging personnel, and clinical trial patients and attends site initiation visits. Oversees the QA initiatives for the department to support research staff and leaders during sponsor and FDA audits.
• Coordinates multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume.
• Other duties as assigned.

This job description does not cover or contain a comprehensive listing of the employee's activities, duties, or responsibilities for this job. In addition, duties, responsibilities, and activities may change at any time with or without notice.

COMPETENCIES

• High energy level; positive attitude; works well under stress, Strong communicator and leader. Hands-on, willing to take action, and able to implement effectively through their team.
• Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency.
• Strong written and oral communication skills.
• Exceptional communication, analytical, presentation, and time management skills.
• Strong computer skills, including Microsoft Office, Excel, and PowerPoint
• Establish and maintain effective working relationships.

QUALIFICATIONS

• Requires significant research regulatory and compliance knowledge, including standard IRB processes, data user and data sharing.
• Minimum of 4-6 years Regulatory Affairs experience in Pharmaceutical, Biologics, In vitro diagnostics, or Medical Devices..
• Working knowledge of complex Federal, State and Local research and HIPAA-related regulations.
• Ability to identify, analyze, and solve problems and work independently.
• Able to multitask and set priorities in a highly demanding environment.
• Excellent verbal, written and interpersonal communication skills.
• Familiar with medical terminology.
• Proficient in using Microsoft Office (Word, Excel, PowerPoint) and databases.
• Working knowledge of IRB regulations, processes, and obtaining informed consent.
• Bachelor's degree or equivalent is required.
• Knowledge of regulations governing clinical research (CFR, GCP, HIPAA) preferred.
• Previous experience with IRB submissions and requirements
• Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint)
• Familiarity with clinical trial management system software, preferably Clinical Research IO
• Basic medical knowledge, including medical terminology.
• Demonstrated competence in oral and written communication.

License And Certification

• Certification in an applicable field (e.g. CIP, CPIA, CCRC/CCRA, or CCRP) is preferred.

  Required Skills