We are seeking an IND/Protocol Development Specialist who will serve as a central resource for faculty conducting investigator-initiated clinical trials at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The candidate will be responsible for reviewing investigator-initiate protocols, filing for Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications to the FDA, long-term IND/IDE management, Institutional Review Board (IRB) approval, and ensuring that all trials conform to Good Clinical Practice (GCP) standards. The IND/Protocol Development Specialist, as part of the centralized Clinical Research Office (CRO), will provide hands-on support for investigators in protocol development, collaborate with the study team through regulatory start-up and study activation, conduct relevant trainings, and monitor compliance of the investigator-held IND/IDE portfolio in the Cancer Center. Long-term IND/IDE management includes submission of pertinent amendments, annual reports, IND safety reports, and Clinical Study Reports to the FDA.
Specific Duties & Responsibilities
Protocol Development & Review
Work closely with the Cancer Center Sponsor-Investigators and Principal Investigators on new investigator-initiated clinical trial protocol development to ensure consistent and comprehensive content and formatting, including SAE reporting, data safety monitoring, and multicenter operation requirements when applicable; assist in review, editing, wordsmithing, and guidance on composition and configuration.
Support PIs and study teams to develop and maintain essential clinical trial documents, such as informed consent documents, pharmacy and laboratory manuals, and to meet registration requirements, such as ClinicalTrials.gov and NCI CTRP database.
Assist PIs and study teams to collaborate with service cores, including IDS Pharmacy, Translational Research Central Services, Biostatisticians, and research laboratories, to ensure inclusive planning and development of comprehensive pharmacy and lab manuals when appropriate.
Track each assigned protocol from development to activation; work with PI and study team to ensure timely, accurate submissions to the financial and material supporters, FDA, scientific review, and IRB; evaluate recurrent problems and develop and implement systems to decrease delays in the approval process.
IND & IDE Management
Provide IND/IDE regulatory guidance to Cancer Center Sponsor-Investigators and study team. Assist Sponsor-Investigators to receive approval from the Office of Clinical Trials (OCT) to submit their IND/IDE to the FDA.
Responsible for preparing initial IND/IDE submissions and working with the study teams to file ongoing submissions with the FDA, such as amendments, annual reports, and safety reports.
Using CRMS and other institutional databases, establish comprehensive tracking for all IND/IDEs held by Cancer Center investigators; provide reports as necessary to leadership and to enable billing.
Work with the IRB, OCT and SKCCC compliance teams when IND/IDE questions arise related to Cancer Center protocols.
Collaborate with Clinical Research Program Managers and study teams to develop best practices for requesting, servicing, and tracking INDs/IDEs; identify any potential problems, inconsistencies, or risks, and suggest and implement improvements to mitigate those risks.
Training & Other Duties
Work with the OCT, other CRO managers and SKCCC leadership to develop a comprehensive education package for new and existing investigators, including in-person or video classes as well as printed materials to be posted on the CRO website. These will include the basic procedures involved in requesting an IND, maintenance of the IND/IDE, and required reporting to the FDA.
As a member of the Clinical Research Review Subcommittee (CRCS), review and comment on investigator-initiated protocols.
Assist the CRO Compliance Manager and study team with any FDA audit-related questions or concerns.
Attend clinical research group meetings when appropriate, and organize meetings with investigators and study teams for specific trials.
Attend professional development meetings hosted by appropriate agencies and organizations such as the FDA, NIH, NCI, and others, to maintain or enhance expertise in the protocol development area.
Required:BA/BS Degree in Biological/Social Sciences or other appropriate discipline required.
Minimum 5 years' experience in research at an academic, government, or pharmaceutical industry regulatory environment, of which minimum 2 years' experience with clinical trials, clinical research sciences, and/or regulatory affairs
Extensive experience with protocol review and study activation process
Additional education may substitute for experience to the extent permitted by the JHU equivalency formula
Licensure, Certification, Registration
Certification as a Clinical Research Professional or Regulatory 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 research protocol and data
Must have working knowledge of IRB & FDA reporting requirements
Knowledge of research methodology and working knowledge of computers required
Knowledge of clinical research practices and principles required
Knowledge of medical terminology required
Excellent organizational and time management skills required
Excellent attention to detail skills required
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.
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.
Classified Title: Clinical Research Program Specialist Working Title: IND Protocol Development Specialist Role/Level/Range: ACRP/04/MC Starting Salary Range: $46,560 - $64,100 annually (commensurate with experience) Employee group: Full Time Schedule: M-F, 830-5 Exempt Status: Exempt Location: Hybrid/School of Medicine Campus Department name: SOM Onc Clinical Research Office Personnel area: School of Medicine
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines:
30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for 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.
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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