Part time Central Regulatory Coordinator

Benefits

Qualifications

• •Bachelor’s degree in life sciences, nursing, or related field
• •Minimum of 2 years of experience in regulatory affairs or clinical research industry
• •In-depth knowledge of regulatory requirements for clinical trials, including FDA regulations, ICH guidelines, and Good Clinical Practice (GCP) standards
• •Strong organizational skills with the ability to manage multiple projects simultaneously and meet tight deadlines
• •Proactive communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders
• •Detail-oriented mindset with a focus on accuracy and quality
• •Prolonged periods sitting at a desk and working on a computer
• •Requires working under stressful conditions or working irregular hours
• •Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time
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Responsibilities

• •We are seeking a highly organized and effective Central Regulatory Coordinator II to join our team remotely
• •As the Central Regulatory Coordinator II, you will be responsible for managing and maintaining regulatory documentation (electronic regulatory binders), serving as a site liaison, and supporting compliance with regulatory requirements
• •This position reports directly to the Directors
• •Lead the centralized regulatory function across all Innovo clinical research sites
• •Develop and/or implement standardized regulatory processes, tools, and templates
• •Manages electronic regulatory binders and associated documentation in accordance with SOPs and regulatory standards
• •Serves as a site liaison to prepare for interim monitoring visits (IMVs), participate in SIVs, kick-off meetings, and conduct close out visits (COVs)
• •Ensure each study is audit-ready (ex
• •IMV preparation, SIV/COV preparation, QA check on eReg, etc.) and support sites as directed in preparation for inspections and monitoring
• •Oversee and support the sites with study start-up collection, preparation, review, and submission of regulatory documents including 1572s, CVs, medical licenses, training logs, and financial disclosures
• •Oversee the drafting, customization, and submission of ICFs across all studies and sites
• •Maintain version control and ensure sites are trained and using the most current IRB-approved versions
• •Responsible for regulatory documentation management; manage and maintain regulatory documentation including Institutional Review Board (IRB) submissions and amendments
• •Includes the timely preparation, submission, and tracking of regulatory documents to the sponsor/CRO and IRB
• •Assist in protocol-specific training to internal teams on protocol requirements, processes, and best practices
• •Identify, report, and assess regulatory risks associated with protocol deviations, amendments, and adverse events, and collaborate with cross-functional teams to mitigate risk
• •Track and maintain training documentation for the research team, as requested, to help ensure compliance with training requirements of Principal Investigators (PIs), Sub-Investigators (Sub-Is), and Clinical Research Coordinators (CRCs)/Research Assistants (RAs)
• •Ensure CVs, medical licenses (MLs), Good Clinical Practice (GCP) training, International Air Transport Association (IATA) training, and Occupational Safety and Health Administration (OSHA) training are up to date
• •Performs all additional duties as assigned
• •This job operates in a remote environment with occasional site visits
• •This role routinely uses standard office equipment such as computers, phones, and scanners
• •Occasionally lifts and carries items weighing up to 15 pounds
• •Occasional evening and weekend work may be required as job duties demand
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