Classified Title: [[Regulatory Specialist II]] Working Title: [[Regulatory Specialist II]] Role/Level/Range: ACRP/03/MB Starting Salary Range: [[$38,536 – $52,989]] 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: 10003204-SOM Sur Clinical Research Office Personnel area: School of Medicine
The Clinical Research Regulatory Specialist II will support clinical research teams (physicians, nurses, etc.) in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects. Will be responsible for ensuring that all research studies maintain accurate and up-to-date regulatory files. Will serve as a central resource for faculty conducting clinical research. This position reports to the Clinical Research Program Manager.
Specific Duties & Responsibilities
Work closely with Investigators and Research Staff on new studies to ensure timely, accurate submissions to the IRB and sponsors.
Understands current regulatory requirements and ensures a smooth submission process to minimize delays to study initiation
Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delay in the approval process.
Will ensure all proper regulatory documents are approved and that all documents, CRF, databases, monitoring/auditing requirements have been completed prior to the start of a study.
Will produce and maintain a regulatory binder prior to the study starting with all required documents and additional sections for future documents.
Obtain all required documents for new submissions, amendment applications, and continuing review activities
Assist Program Manager in the auditing and monitoring of studies, including external sites.
Review studies for data integrity. Generate queries and conduct follow-up for non-compliance issues. Generate QA/QC summary reports and communicate these findings to Investigators and Research Staff. Assist in developing corrective actions for audit and data QA/QC observations when appropriate.
Communicate regularly with Research Staff to review data accuracy, clinical data quality, and overall study progress.
Provide assistance in the submission of Investigational New Drug Applications (IND) or Investigation Device Exemptions (IDE)
Assist in the coordination and review of amendments, annual reports, safety reports, and other regulatory submissions required for maintenance of INDs or IDEs
Assist in compiling and maintaining IND or IDE regulatory files (digital and hard-copy) throughout the lifecycle of trial by ensuring that incoming and historical documents are organized and filed appropriately
Work closely with all sponsors to ensure all regulatory documents are reviewed, approved and correct prior to a study opening
Assist in the development and maintenance of standard operating procedures
Bachelor's degree required. Must have at least 3 years of clinical trial regulatory experience at an academic, government, pharmaceutical industry, or medical device environment.
SOCRA, Certified IRB Professional or other clinical research certifications.
Special Knowledge, Skills, and Abilities
Excellent verbal and communication skills are required. Must be a team player. Must have excellent prioritize skills. Must have familiarity with NIH, GCP, OHRP, and federal regulations for human subject participation in clinical research.
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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