Healthcare Clinical Research Regulatory Affairs Lead

The Regulatory Affairs Lead, in concert with the Director of Regulatory Affairs and Quality Assurance, is accountable for achieving successful delivery of clinical trial activities across a multi-site clinical research network by meeting regulatory and quality requirements. Depending upon study scope, the Regulatory Affairs Lead may manage multiple ongoing clinical trials and projects. Responsibilities include: • Proactively manages study level regulatory aspects of clinical trials including feasibility, study start-up, continuing review, and close-out activity. This includes updating the Studies Tracker and team accordingly. • Schedules pre-selection visits (PSVs) and completes Sponsor/CRO source document agreements or additional feasibility questionnaires as required for the visits. Attends the PSVs and ensures outstanding documents are sent to the Sponsor/CRO representative during or shortly after the visits. • Leads the study start-up process. This includes but is not limited to, preparing and filing of the site essential regulatory documents, reviewing the informed consent(s) for accuracy, completing the initial site IRB submissions, scheduling the site initiation visits (SIVs), creating the study and the investigator site files (ISFs) in CRIO or similar platform for ongoing study management and tracking, and developing the study source documents. • Prepares and submits study documents to the IRB as required. This includes, but is not limited to, new studies, continuing review reports, site closure reports, unanticipated problems, and protocol deviations. Serves as the main point of contact with the IRB for assigned studies. • Notifies the study sites of protocol amendment approvals, including providing the sites with a summary of key protocol changes, communicating the IRB's informed consent ruling, if applicable, and providing a protocol amendment checklist for implementation of the protocol amendment. • Notifies the study sites of updated informed consent approvals, including the rationale for the revision and providing a consent checklist for implementation of the updated informed consent. • Maintains ISFs as assigned. This includes preparing and routing documents for Investigator and study staff review/signature as required and preparing for monitor visits, quality visits and audits. • Prepares for and attends weekly Study Start-Up meetings, biweekly Quality Meetings, SIV meetings, Sponsor/CRO meetings, and other meetings as assigned. Takes action on any outstanding regulatory items. • Ensures effective study timelines are in place and operational for each trial and works proactively with PSL colleagues to set priorities in accordance with applicable study plans, PSL standard operational procedures (SOPs), ICH/GCP guidelines, and regulatory requirements. • Provides regular updates on trial progress to the PSL leadership with respect to study enrollment plans, study timelines, quality standards, and risk mitigation. • Ensures potential study risks are escalated to the attention of the Director when appropriate. • Ensures all study level documents and regulatory documents are filed in the ISF in accordance with PSL SOPs. • Perform other duties and responsibilities as required, assigned, or requested. Qualifications: • Bachelors' degree in Business or Health Science preferred or equivalent experience • 4-6 years of hands-on experience in clinical research, with a strong understanding of study operations and protocols • Proven expertise in regulatory affairs, with a focus on maintaining compliance with clinical research guidelines and industry regulations. • Knowledge of and adherence to Good Clinical Practice (GCP), IATA and FDA regulations. • Requires excellent interpersonal and communication skills. • Requires flexibility, excellent/communication skills, and attention to detail • Must be able to multitask and able to handle a high volume of multiple studies.