[Hiring] Research Regulatory Specialist @Medical University of South Carolina
Role Description
Under the general supervision of the Director, Hollings Cancer Center, Clinical Trials Office, provides functional direction, management, and supervision on a day-to-day basis to the Regulatory staff in the Clinical Trials Office. Oversees the regulatory activities for federal, corporate, and institutional research projects submitted and activated at the Hollings Cancer Center and promotes high quality and efficient regulatory performance as required by the NCI Core Grant.
This position may be eligible for remote work after an orientation period.
• 35% Study Start-up Reporting and Activation Project Management
• Helps to oversee the study start-up process and manages the start-up timeline of all oncology clinical trials assigned within the respective Hollings Cancer Center Disease Focus Group(s) (DFG).
• Responsible for timely, accurate input of required study startup milestones into the Clinical Trials Data System.
• Actively monitors start-up milestones across the HCC Clinical Trials Office (CTO), DFG and PRC, Institutional Review Board (IRB) and reports project updates to respective groups.
• Interfaces with relevant MUSC, sponsor, and Clinical Research Organization (CRO) functional leads.
• Completes the protocol submission form in the Protocol Review Committee (PRC) portal.
• Attends the CTO Pending Projects meetings and specific DFG meetings.
• Effectively communicates regulatory requirements within project teams.
• Provides DFG leaders relevant data on time to activation metrics.
• 35% IRB Application and Document Management
• Responsible for preparation, submission, outcome follow-up, documentation and communication of all IRB submissions.
• Efficiently tracks IRB submissions by utilizing the appropriate process task lists.
• Collaborates with sponsors/CROs to develop informed consent documents.
• Determines appropriate IRB of record and type of regulatory submissions.
• Prepares responses to IRB requests for information or study document revisions.
• Organizes all study documents per policies within hard copy and electronic systems.
• 25% Approval Processing and Quality Assurance
• Complete sponsor required regulatory documentation as required.
• Effectively applies regulatory knowledge of federal regulation and standards.
• Create and maintain essential regulatory documents.
• May go on campus to meet with investigators and staff to obtain signatures for regulatory documents.
• Assist with sponsor and internal monitoring visits and reviews.
• Address and report to the IRB any regulatory findings or follow-up items noted by the site monitor/auditor.
• 5% Regulatory Unit Support and Continuing Education
• Participates in training curriculum and continuing education training of employees.
• Participates in Regulatory coverage plans as needed.
• Works effectively and cooperatively with others in achieving organizational goals.
• Maintains effective relationships with sponsors/CROs.
Qualifications
• A bachelor's degree
• Two years of relevant program experience
Requirements
• Ability to perform job functions in an upright position (Frequent)
• Ability to perform job functions in a seated position (Frequent)
• Ability to perform job functions while walking/mobile (Frequent)
• Ability to work indoors (Continuous)
• Ability to maintain 20/40 vision, corrected, in one eye or with both eyes (Continuous)
• Ability to maintain hearing acuity, with correction (Continuous)
Benefits
• If you like working with energetic enthusiastic individuals, you will enjoy your career with us!
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Under the general supervision of the Director, Hollings Cancer Center, Clinical Trials Office, provides functional direction, management, and supervision on a day-to-day basis to the Regulatory staff in the Clinical Trials Office. Oversees the regulatory activities for federal, corporate, and institutional research projects submitted and activated at the Hollings Cancer Center and promotes high quality and efficient regulatory performance as required by the NCI Core Grant.
This position may be eligible for remote work after an orientation period.
• 35% Study Start-up Reporting and Activation Project Management
• Helps to oversee the study start-up process and manages the start-up timeline of all oncology clinical trials assigned within the respective Hollings Cancer Center Disease Focus Group(s) (DFG).
• Responsible for timely, accurate input of required study startup milestones into the Clinical Trials Data System.
• Actively monitors start-up milestones across the HCC Clinical Trials Office (CTO), DFG and PRC, Institutional Review Board (IRB) and reports project updates to respective groups.
• Interfaces with relevant MUSC, sponsor, and Clinical Research Organization (CRO) functional leads.
• Completes the protocol submission form in the Protocol Review Committee (PRC) portal.
• Attends the CTO Pending Projects meetings and specific DFG meetings.
• Effectively communicates regulatory requirements within project teams.
• Provides DFG leaders relevant data on time to activation metrics.
• 35% IRB Application and Document Management
• Responsible for preparation, submission, outcome follow-up, documentation and communication of all IRB submissions.
• Efficiently tracks IRB submissions by utilizing the appropriate process task lists.
• Collaborates with sponsors/CROs to develop informed consent documents.
• Determines appropriate IRB of record and type of regulatory submissions.
• Prepares responses to IRB requests for information or study document revisions.
• Organizes all study documents per policies within hard copy and electronic systems.
• 25% Approval Processing and Quality Assurance
• Complete sponsor required regulatory documentation as required.
• Effectively applies regulatory knowledge of federal regulation and standards.
• Create and maintain essential regulatory documents.
• May go on campus to meet with investigators and staff to obtain signatures for regulatory documents.
• Assist with sponsor and internal monitoring visits and reviews.
• Address and report to the IRB any regulatory findings or follow-up items noted by the site monitor/auditor.
• 5% Regulatory Unit Support and Continuing Education
• Participates in training curriculum and continuing education training of employees.
• Participates in Regulatory coverage plans as needed.
• Works effectively and cooperatively with others in achieving organizational goals.
• Maintains effective relationships with sponsors/CROs.
Qualifications
• A bachelor's degree
• Two years of relevant program experience
Requirements
• Ability to perform job functions in an upright position (Frequent)
• Ability to perform job functions in a seated position (Frequent)
• Ability to perform job functions while walking/mobile (Frequent)
• Ability to work indoors (Continuous)
• Ability to maintain 20/40 vision, corrected, in one eye or with both eyes (Continuous)
• Ability to maintain hearing acuity, with correction (Continuous)
Benefits
• If you like working with energetic enthusiastic individuals, you will enjoy your career with us!
Apply tot his job
Apply To this Job