Job Discription
Clinical Research Program Specialist
The Department of Cancer Immunology/GI Cancer is seeking a Clinical Research Program Specialist who will serve as a central resource for faculty conducting clinical research at Johns Hopkins University and across multiple clinical trial sites. Under the supervision of the Lead Regulatory Manager, the Clinical Research Program Specialist is responsible for the regulatory filings for Investigational New Drug (IND) applications to the FDA, long-term IND management, Institutional Review Board (IRB) approval, and ensuring that all trials conform to Good Clinical Practice (GCP) standards. Long-term IND management includes submission of protocol, Investigator Brochure, and Chemistry Manufacturing and Controls (CMC) amendments, IND annual reports, IND safety reports, and Clinical Study Reports. This also includes the development of laboratory and pharmacy manuals and the design of clinical databases.
Prior to the start of a study, will ensure that all proper regulatory documents have been approved and that all documents, monitoring/auditing requirements have been completed. During the study, the Clinical Research Program Specialist will ensure all documents are submitted to the FDA and IRB in a timely manner, as well as internally monitor the regulatory files and clinical data to ensure the quality, validity, and integrity of the research. Assist with orientation of less senior research staff on regulatory submission requirements.
Specific Duties & Responsibilities:
Equipment, Machine, or Tool Requirements:
Minimum Qualifications (Mandatory):
* JHU Equivalency Formula: 18 graduate degree credits (semester hours) may substitute for one year of experience. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
** Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
Special Knowledge, Skills & Abilities:
Classified Title: Clinical Research Program Specialist
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $45,650 – $62,850 annually (commensurate with experience)
Employee group: Full Time
Schedule: M-F 9am- 5:00pm
Exempt Status: Exempt
Location: Hybrid/School of Medicine Campus
Department name: Cancer Immunology/GI Clinical Research
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 Talent Acquisition Office at . For TTY users, call via Maryland Relay or dial 711.
Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit and all other JHU applicants should visit .
The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.
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.
Equal Opportunity Employer
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