The Regulatory Specialist II is responsible for all aspects of regulatory compliance and documentation, quality control, as well as organizational training related to GCP and SOP compliance. Maintains communication with the IRB and reviews on-site files, folders, binders, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required. Ensures that essential documents are organized, up to date and in compliance with ICH/GCP guidelines and federal regulations.
Specific Duties & Responsibilities
Maintain the regulatory documents for ongoing studies.
Follows the organization's SOPs and provides guidance with staff comprehension and compliance with the SOPs.
Assist with and coordinate development of clinical trial support documents.
Ensures maintenance of regulatory documents/binders in an organized and systematic fashion to facilitate the monitoring and auditing of research studies.
Ensures IND safety reports are distributed to investigators and research team for review.
Ensures that all required regulatory documents are updated in the site's regulatory binder throughout the life of the study.
Assembles, reproduces and archives (hard and electronic copies) technical documents, as appropriate for the document type.
Report on the status of clinical trials.
Facilitate communication with the IRB and/or Sponsors.
Ensure safety of all patients treated with investigational products/devices and assist with all regulatory filings in this regard.
Performs quality reviews of data generated from clinical trials.
Collaborates with the research team to facilitate overall protocol operations.
Keep documents organized and ready for audit and ready for regulatory filings when required.
Identifies problems and issues and takes corrective action and/or escalates appropriately.
Track sponsor and IRB approvals and renewals.
Generates and reviews reports of regulatory data using appropriate systems.
Assist in training programs as requested.
Uses appropriate IT and software tools to ensure the correct format and presentation of documents.
Ensures all assigned tasks are conducted in accordance with federal regulations and ICH/GCP.
Achieves appropriate quality standards in all documentation within the timelines dictated by project plans and company expectations.
Perform miscellaneous related duties as assigned.
Bachelor's degree in a related discipline.
3 years of related experience required, preferably in clinical research.
Knowledge of GCP/ICH regulatory guidelines and clinical trial processes.
Document management and/or regulatory experience a plus.
Special Knowledge, Skills, and Abilities
Strong proficiency in Microsoft Office programs (Outlook, Word) and Web applications.
Exceptional organizational skills, attention to detail and follow through,
Excellent verbal and written communication skills.
Well-developed interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors and external customers.
Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads.
Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters and other confidential information.
Classified Title: Regulatory Specialist II Working Title: Regulatory Specialist II Role/Level/Range: ACRP/03/MB Starting Salary Range: $38, 536 - $52, 989 / Commensurate with Experience Employee group: Full Time Schedule: Monday - Friday, 8:30a - 5:00p/ 37.5 hours per week Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10003114-SOM PMR Physical Med and Rehabilitation Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at email@example.com. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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