Clinical Study Coordinator

Clinical Study Coordinator (Consultant) About the Company: Propedix is a biopharma and consumer health company dedicated to advancing innovative treatments in healthcare. Our flagship product, featuring our breakthrough anti‑fungal and drying agent technology, launched in Q3 2025, and we have a pipeline of advanced OTC and Rx treatments in dermatology and health. The Company has a pipeline of new skin infection treatment productions planned for launch throughout 2026. All based on the company DryStiK SM Tech Platform. Driven by strong research and development, we’re delivering the next generation of health solutions. Position Overview The Clinical Study Coordinator (CSC) will support the planning, initiation, execution, and closeout of clinical studies across Propedix’s dermatology pipeline. This role will work closely with internal leadership, investigators, CRO partners, and clinical sites to ensure studies are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP), and study protocols. This is a full‑time, on‑site, 1099 contractor role ideal for candidates with strong clinical research experience who are comfortable working in a fast‑paced startup environment. Key Responsibilities Study Start‑Up & Regulatory Support and contribute to protocol development, study materials, and operational plans Coordinate IRB submissions, approvals, amendments, and site activation activities Prepare and maintain essential regulatory documents and investigator site files Support site selection, feasibility assessments, site readiness, and site initiation activities Clinical Trial Operations Serve as a primary point of contact for external clinical sites and investigators Coordinate study timelines, patient recruitment, enrollment tracking, and overall study execution Support or lead participant recruitment efforts, including screening for eligibility, explaining the study, and facilitating enrollment Manage patient visits, including scheduling, data collection, and source documentation Obtain and document informed consent from study participants in accordance with GCP, IRB requirements, and the study protocol. Ensure protocol adherence, track protocol deviations, and troubleshoot operational challenges Support and conduct site initiation training on protocol procedures, workflows, and GCP standards Maintain delegation of authority logs, or ensuring qualified personnel perform tasks Data Collection & Quality Management Oversee accurate and timely completion of case report forms (CRFs), including paper-based systems Perform data entry oversight, validation, and quality checks to ensure data integrity Coordinate secure transfer of de‑identified datasets to internal teams or external partners Maintain Trial Master File (TMF) and ensure audit readiness Support monitoring activities (remote and onsite) and implement corrective actions as needed Safety & Compliance Track and report adverse events (AEs), serious adverse events (SAEs), and protocol deviations per regulatory requirementsEnsure studies are conducted in accordance with GCP, FDA regulations, and applicable guidelinesSupport preparation for audits, inspections, and site qualification visits Cross‑Functional Collaboration Work closely with internal clinical, regulatory, and product development teams Coordinate with external vendors Facilitate communication between sponsor, investigators, CRO partners, and study sites Participate in study meetings and provide regular status updates Relay clinical progress, key findings, and operational challenges to internal stakeholders Location 3 days/week in‑person in Milford and Framingham, Massachusetts. Regular on‑site presence is required to support clinical operations, with occasional travel as needed for site visits or study‑related activities. 1 day/week can be remote. Experience & Necessary Skills Education: Bachelor’s degree in Life Sciences, Public Health, or a related STEM field required Required Experience: 2+ years’ experience coordinating clinical trials, including site management and regulatory processes Familiarity with GCP, FDA regulations, and IRB procedures Experience tracking enrollment targets, retention, or study milestones more explicitly Experience with CRFs (paper or electronic) and clinical data management Strong organizational and communication skills Ability to work independently in a fast‑paced environment Preferred Experience: Experience in dermatology or topical drug studies Experience with sponsor‑side coordination or multi‑site studies Familiarity with Trial Master Files (TMF) and audit readiness processes Exposure to CRO collaboration and vendor management Familiarity with common eClinical systems, EDC systems, or basic tools like CTMS is preferred Hours Approximately 30 hours per week. Candidates are required to attend a company‑wide meeting on Tuesday evenings. This role requires a flexible schedule, including availability for occasional evening and weekend work, with the ability to complete certain responsibilities remotely as needed. Compensation $25 - 30 per hour, depending on experience. This is an independent contractor 1099 position. Support and Supervisor The position reports to the Chief Medical Officer who will be the administrative supervisor and will also work closely with clinical vendors and the formulation team. #J-18808-Ljbffr