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

Equal Opportunity Employer:

Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.