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The Johns Hopkins University
Baltimore, MD, United States
Press Tab to Move to Skip to Content Link Johns Hopkins strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The seasonal flu vaccine requirement remains unchanged. Exceptions may be provided under certain circumstances. Click here for more information. Johns Hopkins strongly encourages, but no longer requires,
Job Source: The Johns Hopkins UniversityThe Johns Hopkins University
Baltimore, MD, United States
Press Tab to Move to Skip to Content Link Johns Hopkins strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The seasonal flu vaccine requirement remains unchanged. Exceptions may be provided under certain circumstances. Click here for more information. . Select how often (in days) to receive an alert: Crea
Job Source: The Johns Hopkins UniversityLinkedIn - Jobboard
, MD, United States
Position: Regulatory Affairs Specialist Location: Sparks, MD Duration: 3+ Months Contract Total Hours/week: 40.00 1st shift The Individual Will Work With Global Colleagues To Support Korea, China, And/Or Other Countries As They Fulfill Requirements To Register Products Regulatory Affairs is responsible for planning, coordinating and implement
Job Source: LinkedIn - JobboardAir Force Institute of Technology
, MD, United States
If you have experience managing clinical trials and providing regulatory support AND you want to play a significant role in a dynamic organization, then consider joining the Center for Cancer Research (CCR), Office of the Clinical Director (OCD) at the National Cancer Institute (NCI)! For more information please visit: https://ccr.cancer.gov/abou
Job Source: Air Force Institute of TechnologyNational Institutes of Health
, MD, United States
National Institutes of Health Regulatory Affairs Specialist Montgomery County , Maryland Apply Now Summary If you have experience managing clinical trials and providing regulatory support AND you want to play a significant role in a dynamic organization, then consider joining the Center for Cancer Research (CCR), Office of the Clinica
Job Source: National Institutes of HealthAlbireo Energy, LLC
, MD, United States
This position is responsible for assisting in the operation of the department. An individual in this position will be expected to perform additional job-related responsibilities and duties throughout the facility as assigned and or as necessary. In addition to the responsibilities below, the Systems Specialist II performs routine technical duties i
Job Source: Albireo Energy, LLCJohns Hopkins University
Baltimore, MD, United States
The Enterics Laboratory at Johns Hopkins University is seeking a full-time Research Specialist II to assist with ongoing projects in the lab. The Research Specialist will be principally responsible for performing laboratory tests and/or experiments and providing analytical and administrative assistance for several studies involving collaboratio
Job Source: Johns Hopkins UniversityJohns Hopkins Medicine
Baltimore, MD, United States
Responsible for providing plan administration, participant communications, and customer service support as directed by the Benefits Director. The Benefits Specialists II will provide Tier III customer response to inquiries and escalated issues from the Human Resource Solution Center (HRSC) team and utilize this experience to provide input to custom
Job Source: Johns Hopkins MedicineBaltimore, MD, United States
Under the supervision of the OCT Director, we are seeking a Regulatory Specialist II (RS) who will support investigator(s) and study team(s) in initiating studies. The RS will proactively engage with Principal Investigators (PIs) and their teams upon execution of Non-Disclosure Agreements/Confidentiality Disclosure Agreements (NDA/CDAs) to offer assistance with study start-up. Upon request, the RS will provide guidance to clinical research staff in preparing comprehensive study documents for submission to Institutional Review Boards (IRBs)/central Institutional Review Boards (cIRBs), the Clinical Research Contract team (CRC), Clinical Research Support Service team (CRSS), Investigational Drug Services (IDS), ancillary committees, and Sponsors/Contract Research Organizations (CROs). Acting as a central point of contact, the RS will ensure adherence to submission and approval timelines and facilitate communication with Sponsors/CROs and other stakeholders. Additionally, the RS will establish and maintain a tracking system to streamline the study start-up process and minimize delays. Operational support related to OnCore (JHM Clinical Trial Management System), including the eReg platform, and managing DocuSign requests will also fall within the RS's responsibilities.
If an Investigational New Drug/Device Exemption (IND/IDE) is necessary, the RS will collaborate closely with the Director for IDE/IND submissions for FDA clearance.
The role demands meticulous organization, keen oversight, a deep understanding of study start-up processes, and exceptional communication abilities.
Specific Duties & Responsibilities
Study Start-Up
Support investigator(s) and study team(s) with study start-up.
Attend study start up meetings if requested.
Create advertising, if appropriate.
Ensure investigator(s) and study team(s) have completed required training.
Prepare accurate IRB submissions and obtain timely IRB approval.
Submit NDA, clinical trial agreement/contract, and budget approval for review and execution.
Work closely with all OCT offices and pro-actively oversee study submissions.
Ensure that eCRF, databases, and other essential study documents have been created.
Create and/or review study-specific documents (i.e. case report forms) and other study-related materials and supplies.
Assure all study documents are complete and consistent.
Provide requested documents to Sponsor and/or CRO and assist Sponsor/CRO.
Track study documents through the various offices during study start-up phase (from submission through approval) and ensure smooth implementation of new trials from conception through study activation.
Administrative Support
Develop and implement tracking systems to decrease delay in the study start-up process/activation.
The creation and maintenance of trackers is vital for monitoring various metrics related to study start-up to be able to evaluate real-time visibility into performance indicators.
Create essential Study Start-Up documents such as Checklists, Tip Sheets, and Q&A Documents, necessary for study start-up efficiency.
DocuSign Management: Responsibilities including managing DocuSign requests for electronic signatures, reviewing ICF templates, setting up users, and communication with staff and IRB.
Greenshire ClinCard, Offering assistance to clinical research teams seeking to utilize Greenshire ClinCard as a payment method for research participants.
Assist with the Office of Clinical Trials (OCT) website management.
Assist with Coordinating OCT activities such as the OCT Retreat and Clinical Trials Day.
Perform other duties as assigned.
Minimum Qualifications
Bachelor's Degree in related discipline.
A minimum of 3 years of experience in academic or industry-based clinical research.
Knowledge, Skills & Abilities
Excellent verbal and communication skills.
Excellent organizational skills.
Strong knowledge of GCP, ICH, OHRP, and local, State, & Federal regulations related to research with human subjects.
Familiar with Sponsor and FDA reporting requirements.
Experience with entering information in a Clinical Trial Management System.
Ability to simultaneously manage multiple projects, and effectively prioritize each.
Preferred Qualifications
Previous experience in the job function as research assistant, coordinator, or regulatory coordinator for commercially funded studies with a focus on human clinical research is preferred.
Strong knowledge of the regulatory requirements pertaining to the conduct and oversight of clinical trials.
Familiar with OnCore and DocuSign.
Classified Title: Regulatory Specialist II
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $40,900 - $71,600 Annually ($65,000 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
Exempt Status:Exempt
Location:Remote
Department name: SOM Admin Res Clinical Research Contract
Personnel area: School of Medicine
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Email Alert for Regulatory Specialist II jobs in Baltimore, MD, United States
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