The Clinical Research Regulatory Specialist II will serve as a central resource for faculty conducting clinical research at Johns Hopkins University and across multiple clinical trial sites. Working closely with the Sponsor-Investigator, this position will assist in the submission of investigator initiated trials to the appropriate regulatory agencies for review, such as the Food and Drug Administration (FDA) and Recombinant DNA Advisory Committee (RAC). This position will also submit initial applications to the IRB and other regulatory agencies, setting up and maintaining regulatory records, assisting budget development, and maintaining sponsor relationship.
In addition, this position will assist in the ongoing maintenance of Sponsor-Investigator held INDs. This includes, but is not limited to protocol amendments, Investigator Brochure amendments, annual reports, IND safety reports, Chemistry, Manufacturing, and Controls (CMC) updates, and oversight of investigational drug supply.
DUTIES AND RESPONSIBILITIES:
Provide assistance in the submission of Investigational New Drug Applications (IND)
Provide regulatory guidance to IND sponsors, clinical investigators, and clinical staff for investigator initiated clinical trials
Provide assistance with IND management and submissions
Coordinate and review documentation for amendments, annual reports, safety reports, and other regulatory submissions required for maintenance of INDs
Compile and maintain IND Sponsor regulatory files (digital and hard-copy) throughout the lifecycle of sponsorship by ensuring that incoming and historical documents are organized and filed appropriately
Assist with IRB protocol development and revision of investigator-initiated studies: Assure protocols, amendments, consent forms, and study operation manuals have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc.
Review clinical trial databases to assess clinical data quality and accuracy
Monitor investigational drug supply
Prep and submission of IRB regulatory documents for new submissions, continuing reviews, amendments, and responses to IRB questions
Involved in Budgets/Contracts development which involves taking the schedule of activities from the IRB to construct a preliminary budget for the sponsor
Other clinical research, administrative, lab support and regulatory duties as required.
Bachelor’s degree in health sciences, biological sciences, or related field. Three years clinical trial regulatory experience at an academic, government, or pharmaceutical industry environment.
Advanced degree in regulatory, health sciences, biological sciences, or related field.
Special Knowledge, Skills, or Abilities / Competencies:
Good verbal and written skills are required, as is a basic knowledge of computer science
Ability to work independently, coupled with organizational and time management skills.
Excellent attention to detail required.
Familiar with medical and laboratory procedures.
Ability to handle multiple and competing priorities.
Ability to interact appropriately and productively with faculty within and outside JHU, staff and Pharma representatives at all levels.
Additional education may substitute for experience.
Knowledge of research methodology and working knowledge of computers.
Knowledge of clinical research practices and principles.
Highly effective verbal and written communication skills, and highly developed interpersonal skills. .
Must be able to independently assimilate and evaluate clinical data.
Proficiency in Microsoft Office, especially Excel and Word, and a working knowledge of Access or other relational database.
Classified Title: Regulatory Specialist II Working Title: Regulatory Specialist II Role/Level/Range: ACRP/03/MB Starting Salary Range: $38,537 - $52,989 Employee Group: Full Time Schedule: m-F 8:30-5:00 Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department Name: 10003169-SOM Rad Nuclear Medicine 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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Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.