We are 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:
Work closely with the IND sponsor and PI on new studies to ensure timely, accurate submission to the IRB, sponsors, and FDA.
Submit IND amendments to the FDA. These include IND annual reports, FDA requests for information, Clinical Study Reports, as well as protocol, CMC, and information amendments.
Submit IND safety reports to the FDA for investigator-initiated studies.
For IND studies, maintain accurate and up-to-date documents and submissions.
Assure protocols have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc.
Obtain all required documents for new submissions to the IRB.
Complete new study IRB submissions.
Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delay in the approval process.
Supervise research coordinators and future regulatory staff on regulatory duties to ensure protocol and regulatory compliance.
Supervise and guide future regulatory specialists regarding informed consent development and protocol amendments for investigator-initiated studies.
Develop and maintain clinical trial documents such as pharmacy and laboratory manuals.
Develop and maintain the clinical trial database
Internally monitor regulatory files and clinical data to assess compliance, data quality, and accuracy.
Contribute feedback to the Senior Clinical Research Program Manager on the progress of research staff while performing regulatory duties.
Complete IRB amendment submissions and ensure documentation of training.
Ensures smooth implementation of new trials from conception through study activation.
Work closely with the protocol compliance team to ensure all documents are ready prior to a study opening.
Attend study start up meeting for studies including those where SKCCC is the coordinating center.
Participate in site initiation visits for studies where Hopkins is the Coordinating Center and Cancer Center investigator is the Lead or Protocol Chair.
Produce and maintain a regulatory binder prior to study starting with all required documents.
Work closely with all sponsors to ensure all documents are reviewed, approved and correct prior and during the study.
Ensure all documents are being collected in a timely manner and all regulatory binders are up-to-date.
Assist with study monitoring/auditing requirements.
Develop standard operating procedures for regulatory submissions as needed.
Oversite while study coordinators are working on IRB regulatory submissions including
Continuing Renewals and SAE submissions.
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.
Review and analyze new studies for difficulties that may arise with study processes and procedures. Suggest appropriate alternatives to possible complications.
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. Teaches staff about regulatory aspects.
Updates faculty on regulatory study status.
Maintain clinicaltrials.gov compliance.
Equipment, Machine, or Tool Requirements:
General computer skills, with Microsoft Office experience
Minimum Qualifications (Mandatory):
Required BA/BS Degree in Biological/Social Sciences or other appropriate discipline required.
Advanced degree may substitute for some experience.
Certification as a Clinical Research Professional is preferred.
Minimum of 5 years clinical trial experience at an academic, government, or pharmaceutical industry environment is required. Additional education may substitute for experience.
Knowledge of research methodology and working knowledge of computers required.
Knowledge of clinical research practices and principles required.
Highly effective verbal and written communication skills, and highly developed interpersonal skills required.
*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, or Abilities:
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 clinical database is required.
Must be familiar with medical terminology.
Must be experienced in handling multiple tasks at once, and working well as a member of a team.
Must have working knowledge of FDA reporting requirements.
Excellent organizational skills required.
Excellent attention to detail required.
Must have excellent prioritize skills.
Must have familiarity with NIH, GCP, and federal regulations for human subject participation in clinical research.
Ability to handle multiple and competing priorities.
Ability to interact appropriately and productively with staff at all levels.
Must have excellent time management skills.
Classified Title: Clinical Research Program Specialist Role/Level/Range: ACRP/04/MC Starting Salary Range: $45,649- $62,850, Commensurate with experience Employee group: Full Time Schedule: M-F 8am-4pm Exempt Status: Exempt Location: School of Medicine Campus Department name: Cancer Immunology/GI Clinical Research 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.
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 firstname.lastname@example.org. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu.
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.
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