Classified Title: Regulatory Specialist II Working Title: Role/Level/Range: ACRP/03/MB Starting Salary Range: Commensurate with Experience Employee group: Full Time Schedule: M-F; 8:30 am - 5:00 pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 60002728-NUS Pain Institute Personnel area: School of Medicine
The Regulatory Specialist II has the overall responsibility of facilitating development and monitoring the progress of a large multicenter clinical trial in the Department of Neurosurgery. Oversee the development and management of the clinical trial and develop associated strategic relationships with vendors, researchers, and clinicians in accordance with study objectives and applicable regulations.
Specific duties & responsibilities:
Participate in the analysis, planning and strategic formation of program goals for assigned trial.
Coordinate and oversee all research activities for a large multi-center clinical trial, preparing and compiling all reporting information needed for IRB, FDA, and industry sponsors
Anticipate or identify project needs and maintain a development plan that is consistent with the latest regulatory requirements, cost-effective and efficient, and provides for safety of participating subjects.
Manage the relationships with development partners and external vendors (i.e.: CROs, consultants). Serves as a central resource for collaborators conducting research.
In coordination with contract research organizations (CRO), oversee implementation of the clinical study to maintain protocol and regulatory compliance for activities such as informed consent, patient safety, and quality data.
Implement supplier audits to support ongoing compliance.
Develop and implement SOPs for the clinical trial and related activities.
Author and/or review and approve study documents.
Prepare metrics and summaries to effectively communicate status and recommendations to Senior Management.
Ensure and/or conduct required training for investigator sites on the clinical trial; including but not limited to Investigator Meetings, policies, procedures, study conduct, data management, and regulatory requirements.
Support Pharmacovigillance activities as required.
Provide recommendations and input regarding departmental policies, procedures, goals and objectives; make judgments and decisions in a sound logical manner.
Provide direction to other team members.
Attends and participates actively in research management meetings. Assists PI with protocol development which may include writing informed consents.
Initiate and/or maintain activities, systems and processes to increase referrals and increase accruals to multiple clinical trials.
In coordination with the CRO, ensures all proper regulatory documents have been approved and that all documents, CRF, databases, monitoring/auditing requirements have been completed.
Assures protocol and study manuals have complete, consistent language throughout, including proper SAE (serious adverse event) reporting requirements, coordinating center requirements, etc.
Evaluates for recurrent problems. Develops and implements systems to decrease delays.
In coordination with the CRO, prepares and submits FDA reports for IND application
Minimum qualifications (mandatory):
Bachelor degree required, preferably in Life Sciences or related field, and at least 3 years of experience in clinical research at an academic, government, or pharmaceutical industry environment.
Thorough knowledge of cGCPs, FDA/ICH and global regulatory requirements
Experience in writing/reviewing clinical trial and regulatory documents
Experience in protocol and informed consent writing, data analysis, and /or manuscript preparation required. Experience in budget generation, contractual process and financial management of clinical trials preferred.
Experience with CROs, Investigative Sites
Strong organizational, interpersonal and communication skills to plan and accomplish goals
Team-oriented approach to project management and problem resolution
Additional education may substitute for experience.
The successful candidate(s) for this position will be subject to a pre-employment background check.
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During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
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