We are seeking a Regulatory Specialist II who will work under limited supervision of the Sr. Clinical Research Program Manager and will be responsible for managing regulatory start-up of clinical trials, assisting development of investigator-initiated studies, maintaining sponsor relationships, and facilitating compliance and continuing education trainings for the Sibley Oncology Research Office. Regulatory start-up activities include site evaluation visits, feasibility surveys, initial applications to the IRB and other regulatory agencies, and internal quality control of regulatory document management. This position requires a high level of knowledge, oversight, and organization, and will serve as a central resource for faculty conducting clinical research. Responsibilities will also include orient and train research staff in the program, assist budget development and oversee overall study coordination, and support general operations of the program.
Specific Duties & Responsibilities:
Work closely with Program Manager and PI's to evaluate new concepts and complete pre-study regulatory requirements, including site selection visits, to ensure timely study submission and smooth activation.
Assist with 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.
Work closely with PI's and sponsors to complete all new study submissions to the IRB, Cancer Center Cores (such as TSCRC Lab and IDS Pharmacy), and other required regulatory documents.
Track each protocol through Oncology and IRB approval process, evaluate for recurrent problems, develop and implement systems to decrease delay in the approval process.
For IND studies, maintain accurate and up-to-date documents and submissions.
For multicenter studies where SKCCC is the coordinating center, work closely with the project manager to collect and review regulatory documents from participating sites prior to study activation, attend study start-up meeting, maintain communication with sites to ensure high quality of data, timely submission of data, and adherence to guidelines.
Conduct internal quality assurance measures, including periodic monitoring and training sessions, to ensure all clinical research faculty and staff within the program are up-to-date with regulatory guidelines, standard operating procedures, and certification requirements.
Maintain a continued high level of expertise in institutional databases including Epic, CRMS, eIRB, using this proficiency to ensure accurate data and analysis are sustained for all trials within the program.
Support Program Manager with the full cycle of the protocol approval process – development, submission, contract negotiation, budget development, interaction with Cancer Center Cores.
Assist PI with abstracts and manuscripts preparation.
Assist Program Manager with program operations and staff orientation and training – providing suggestions for improved procedures, creating checklists and program-related standard operating procedures.
Participate as requested in Cancer Center initiatives such quality-improvement workgroups and committee meetings.
Complete minimum requirements for continuing education units. Maintain up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies.
Ensure that Cancer Center policies, standard operating procedures, and guidelines related to the conduct of clinical trials are followed.
This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent(s). It should not be held to exclude other duties not mentioned that are similar in nature and level of difficulty.
Equipment, Machine, or Tool Requirements:
General computer skills, with experience with Microsoft Office.
Minimum Qualifications (Mandatory):
BA/BS Degree in Biological/Social Sciences related discipline required.Master's preferred.
Requires minimum of 3 years of experience in academic, government, or industry-based clinical research. Must have familiarity with NIH, GCP, OHRP, and federal regulations for human subject participation in clinical research
Experience in clinical trial and/or clinical research in a patient setting required.
Additional education may substitute for required experience and additional experience may substitute for required education to the extent permitted by the JHU Equivalency Formula.*
*JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for the required education on the same basis. 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.
Licensure, Certification, Registration:
Certification as a Clinical Research Professional is preferred.
Special Knowledge, Skills, or Abilities:
Highly effective verbal and written communication skills, and highly developed interpersonal skills required.
Must be able to independently assimilate and evaluate clinical and research data.
Must have working knowledge of IRB & FDA reporting requirements.
Knowledge of research methodology, clinical research practices and principles required.
Knowledge of medical terminology required.
Excellent organizational and time management skills required.
Excellent attention to detail skills required.
Proficiency in Microsoft Office, especially Word and Excel.
Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information.
Understands the importance/impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general.
Regular contact with physicians, other health care personnel and occasionally, patients, requires the use of good judgment, tact and sensitivity.
Classified Title: Regulatory Specialist II Role/Level/Range: ACRP/03/MB Starting Salary Range: $39,310 - $54,060 annually (commensurate with experience) Employee group: Full Time Schedule: M-F 8am-4:00pm Exempt Status: Exempt Location: Remote Department name: SOM Onc Sibley 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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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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Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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