General Summary/Purpose: The CTU Regulatory and Safety Affairs Officer will serve as the Director of Regulatory Affairs and Safety Reporting for the JHU-Uganda HIV Clinical Trials Unit (CTU) and other studies being conducted by the CTU PIs. This position will serve as the primary point of contact and liaison with the JHU CTU Clinical Research Sites for Regulatory Affairs and Safety Reporting matters, and provide leadership and oversight to ensure regulatory compliance with CTU operations. A key responsibility area of this position will be preparation of IRB protocol materials for submission by the JHU CTU PIs; and preparation of draft responses to the IRB for the CTU PIs. The Regulatory affairs and Safety Affairs Officer will ensure that the conduct of regulatory activities within the CTU and its affiliated Clinical Research Sites (CRSs) will meet all DAIDS/NIH, Network and JHMI IRB regulatory requirements. The Regulatory Affairs Officer will be responsible for maintaining a current knowledge of regulatory guidance, including, but not limited to, the United Stated Food and Drug Administration, International Council for Harmonization, International Organization for Standardization,. They will be able to review and audit for institutional training, completeness of DAIDS Network-specific regulatory training, and competency compliance for regulatory personnel at the JHU affiliated international research sites. They will be able to demonstrate good writing skills in order to develop Standard Operating Procedures (SOPs) and daily communication with the CTU leadership and component CRSs. He or she will be responsible for reporting Serious Adverse Events and protocol deviations to JHMI IRBs once the CTU affiliated CRS has drafted the reports including attribution of relationship of the events to study drugs or interventions.
Other roles include working with the JHU PIs and international CTU site investigators on grant submissions; preparation of study-specific budget preparation and modification; as well as interacting with JHU Office of Research Administration (ORA), DAIDS Networks leadership. This position includes participation scientific manuscript development for publications, representation of the CTU at DAIDS meetings, and opportunity for short term international travel to the CTU research sites in Uganda. The person hired into in this position will work under the supervision of the CTU Administrative PD/PI and interact closely with the other CTU PD/PIs and CTU Coordinator; as well as provide technical support to the affiliated CRS regulatory staff.
Specific Duties and Responsibilities:
Generate and prepare JHU IRB submissions of already finalized CTU/CRS study protocols for the JHMIRB including but not limited to initial protocol submissions, Clarification Memos and Letters of Amendment, annual reports, and protocol events.
Maintain overarching CTU regulatory procedures including preparation of Standard Operating Procedures in compliance with both HU IRB and sponsor regulatory requirements
Remain up to date with changes in regulatory legislations and NIH and Network guidance
Review, communicate, and disseminate appropriate recommendations/guidance from national and international oversight organizations (eg NIH, FDA, ICH, ISO, etc.).
Maintain orderly CTU and other JHU PI regulatory files working closely with the JHU CTU Administrative Assistant
Provide technical guidance and oversight to the CTU Admin Assistant to communicate JHU IRB communications (eg JHMI IRB protocol queries, IRB approvals to the relevant CRSs concerning specific studies)
Provide Technical support to the CRS regulatory Support; and communicate on a regular basis by email and conference calls.
Ensure that all JHU CTU and NIH regulatory quality standards are met
Keep up to date on all required JHMI regulatory and other required JHMI trainings
Other Roles and Duties
Under the direction of the PD/PIs, help prepare grant submissions
Support the JHU CTU PIs in budget preparations
Interfaces closely with the CTU Coordinator, and CRS regulatory staff
Provide educational materials and training to CTU and CRS staff in regards to regulatory compliance.
Lead in-services on regulatory updates.
Participate in NIH CTU trainings and protocol conference calls.
Short term travel as conditions permit to the international CRSs to support CTU regulatory work
Other roles and responsibilities as assigned by the CTU Administrative PI.
Supervision of Others: Informal. In area of Regulatory submissions, provides oversight to the CTU Administrative Assistant for communicating JHU IRB findings to relevant CRS staff. Also provides technical support to the CTU affiliated CRS regulatory staff, including mentoring, protocol regulatory training, or guides the work of others as project related.
Minimum Qualifications (mandatory): J.D. from an accredited law school and a member of the Bar of the State of Maryland in good standing (or admitted to the bar of another state) required. Education in biology, chemistry, laboratory science, or related medical field. 3 years of compliance or administrative experience related to human research studies. Progressive responsibility in international research which include understanding of regulatory requirements for conduct of clinical trials and other types of studies, familiarity with regulated environment at JHU and international sites, Regulatory oversight and familiarity with US FDA, EMA, ISO and ICH guidance.
Preferred Qualifications: Will consider candidate with PhD. degree with relevant regulatory and safety experience. Prior experience and exposure to working internationally or supporting international projects.
Special Knowledge, Skills, and Abilities:
Experience working with Federal regulations and sponsored projects for educational institutions.
Familiarity with the regulatory agencies involved in human research and pertinent laws and regulations as well as the ethical considerations related to that subject highly desirable. Must have the ability to apply regulatory requirements to proposed research protocols, exhibit skills in conducting research using electronic methods, and possess exemplary writing and verbal skills. Experience in group process and dynamics and working as an active team member.
Excellent verbal and written communication skills required. Strong writing and editing ability. Excellent organizational skills, strong attention to detail and the ability to manage multiple tasks simultaneously required. Excellent interpersonal skills and cultural sensitivity required. Strong computer and IT skills.
Experience in project management, and international research or projects preferred. Formal training in project management and strong knowledge of project management software programs.
Experience in international travel and logistics arrangements.
Ability to work independently in a small team environment, but also to collaborate with other office members and outside contacts including culturally diverse international staff in the pursuit of team goals.
Equipment, Machine, or Tool Requirements: Computer, Scanner, Copier, Telephone, Fax
Work Environment /While performing the duties of this job:
While performing the duties of this job, the employee may remain in a stationary position (sitting) up to 75% of the time when in the office setting.
The employee is required to operate computer keyboard for a significant portion of the work day. Prolonged vision requirements including viewing computer screen, paper reports/documents, charts and results.
While this position is primarily in an office setting, there are times where the employee might inadvertently be exposed to a medical environment. While exposure to toxins and infectious agents are unlikely, but potential for personal injury or harm is minimized if established safety and health precautions are followed. Must refer to and are expected to comply with procedure manuals, follow proper protocols and safety policy/procedures, and be familiar with material data safety sheets in assigned work areas.
Staff will complete annual competency review, and must insure compliance with Johns Hopkins Policy, Laboratory Policy & Procedures, Health, Safety & Environment regulations, and all applicable privacy & confidential laws/practices.
Classified Title: Human Research Compliance Associate Working Title: Human Research Compliance Associate Role/Level/Range: ATP/04/PE Starting Salary Range: $69,140 - $95,005 annually Employee group: Full Time Schedule: M-F 8:30a-5:00p Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10003068-SOM Pat HIV Clinical and Research Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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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