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KIDNEY CARE SPECIALISTS LLC

Job Overview The Lead Clinical Research Coordinator is responsible for the comprehensive oversight, coordination, and execution of all clinical research operations at the site level. This role ensures strict adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines while supporting the efficient, compliant, and high quality conduct of clinical trials. This position encompasses a broad scope of responsibilities across clinical care, regulatory compliance, data management, site operations, and program development. The Lead CRC will serve as the primary liaison between investigators, sponsors, CROs and internal stakeholders, while also supporting infrastructure development and future expansion of research activities. Key Responsibilities1. Clinical Trial Coordination &amp; Study Management<ul><li>Coordinate and manage all phases of clinical trials, including feasibility, start-up, activation, enrollment, maintenance, and close-out</li><li>Ensure strict compliance with study protocols, GCP, FDA regulations, and IRB requirements</li><li>Maintain study timelines, enrollment targets, visit schedules, and milestone tracking</li><li>Serve as primary point of contact for sponsors, CROs, monitors, and auditors</li><li>Prepare for and actively participate in site initiation visits (SIVs), monitoring visits, audits, and regulatory inspections</li><li>Facilitate sponsor communications, investigator meetings, and study updates</li><li>Support site feasibility assessments and protocol review</li></ul>2. Patient Care &amp; Clinical Responsibilities<ul><li>Perform clinical duties including phlebotomy (blood draws), specimen collection, processing, centrifugation, labeling, storage, and shipment in accordance with protocol and laboratory requirements</li><li>Obtain and document vital signs, medical histories, medication reconciliation, and clinical assessments</li><li>Assist with patient screening, eligibility determination, informed consent process, and enrollment</li><li>Room patients and coordinate patient flow for study visits</li><li>Prepare exam rooms, equipment, and study-specific materials prior to patient encounters</li><li>Perform or assist with study-related procedures as permitted by protocol and training</li><li>Monitor patient safety, identify adverse events (AEs/SAEs), and ensure proper reporting per protocol and regulatory standards</li><li>Provide patient education regarding study participation, procedures, and follow-up requirements</li></ul>3. Data Management &amp; Source Documentation<ul><li>Maintain accurate, complete, and timely data entry in electronic data capture (EDC) systems</li><li>Resolve data queries and ensure data integrity and consistency</li><li>Maintain source documentation in compliance with ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate)</li><li>Ensure all documentation is audit-ready and aligned with sponsor and regulatory expectations</li><li>Assist with data reconciliation, reporting, and quality review processes</li></ul>4. Regulatory &amp; Compliance Management<ul><li>Maintain and organize regulatory binders and essential study documents</li><li>Prepare and submit IRB applications, amendments, continuing reviews, and reportable events</li><li>Ensure compliance with GCP, FDA regulations, HIPAA, and applicable federal and state requirements</li><li>Maintain inspection readiness at all times</li><li>Ensure proper document retention and version control practices</li></ul>5. Site Operations &amp; Compliance (High Priority Scope)<ul><li>Complete and maintain all required site-level regulatory and compliance logs, including but not limited to:</li><li>Refrigerator and freezer temperature logs</li><li>Medication and investigational product accountability logs</li><li>Laboratory and specimen tracking logs</li><li>Equipment calibration, maintenance, and cleaning logs</li><li>Delegation of authority logs</li><li>Staff training and certification logs</li><li>Adverse event and deviation tracking logs</li><li>Any additional logs required by protocol, sponsor, or regulatory standards</li><li>Ensure all logs are accurate, current, complete, and audit-ready at all times</li><li>Monitor, track, and manage clinical and research supply inventory, including:</li><li>Ordering supplies</li><li>Receiving and verifying shipments</li><li>Proper storage and organization</li><li>Inventory reconciliation</li><li>Ensure all medications, specimens, and supplies are stored in accordance with protocol, manufacturer, and regulatory requirements</li><li>Routinely review and remove expired, damaged, or non-compliant materials</li><li>Maintain overall site organization, cleanliness, and operational readiness</li></ul>6. Meetings, Reporting &amp; Quality Oversight<ul><li>Participate in all applicable internal and external meetings, including sponsor meetings, investigator meetings, monitoring visits, and operational reviews</li><li>Prepare and present study data, reports, and performance metrics</li><li>Maintain and update tracking tools, dashboards, and enrollment reports</li><li>Participate in quality assurance (QA) and quality improvement (QI) initiatives, including:</li><li>Internal audits</li><li>Chart reviews</li><li>Compliance assessments</li><li>Identify trends, gaps, or risks and assist in implementing corrective and preventive actions (CAPAs)</li><li>Ensure continuous alignment with protocol, regulatory, and organizational quality standards</li></ul>7. Operational &amp; Program Development<ul><li>Support development and refinement of workflows, policies, and standard operating procedures (SOPs)</li><li>Assist in building infrastructure to support program scalability and multi-site expansion</li><li>Identify opportunities for process improvement and operational efficiency</li><li>Assist in onboarding, training, and mentoring new staff</li><li>Support strategic initiatives related to clinical research growth</li></ul>8. Administrative &amp; General Responsibilities<ul><li>Coordinate scheduling of study visits, follow-ups, and patient communications</li><li>Maintain professional communication with patients, providers, sponsors, and internal teams</li><li>Support reporting, tracking, and operational documentation as needed</li><li>Ensure confidentiality and compliance with all privacy requirements</li></ul>Qualifications/Education/Experience<ul><li>Clinical Research Coordinator experience preferred, however will consider training candidate</li><li>Experience managing clinical trials preferred.</li><li>Candidates with STRONG clinical, adminsitrative, and regulatory experience may be considered in lieu of direct clinical research experience, with structured training provided in clinical research operations.</li></ul>Requirements/Work Environment/Essential Functions<ul><li>This position operates in a clinical and administrative environment requiring regular movement throughout the site and in two office locations. (Chestnut Hill and Broomall PA areas)</li><li>Responsibilities include a combination of clinical, operational, and administrative duties.</li><li>The role may require standing, walking, bending, and remaining active for extended periods during patient care and site operations.</li><li>Ability to lift, move, and organize supplies and equipment generally up to 25 lbs.</li><li>May involve assisting with patient mobility, including escorting or transporting patients as appropriate.</li><li>Responsibilities may include stocking exam rooms, organizing supplies, preparing clinical areas, and supporting site setup and operational readiness</li><li>Requires manual dexterity and coordination for handling clinical specimens, equipment and documentation</li><li>Duties may vary based on operational needs, and the employee may be required to support general site operations and clinical workflow activities.</li></ul>**This description is intended to reflect the general scope of responsibilities associated with this position, however is not intended to be an exhaustive list of all duties.Pay: $80,000.00 - $100,000.00 per yearBenefits:<ul><li>401(k)</li><li>Dental insurance</li><li>Flexible spending account</li><li>Health insurance</li><li>Health savings account</li><li>Life insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Work Location: In person

Lead Clinical Research Coordinator

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KIDNEY CARE SPECIALISTS LLC

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Lead Clinical Research Coordinator