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, were delivering the next generation of health solutions.

Position: Clinical Study Coordinator (Consultant)

Position Overview:
The Clinical Study Coordinator (CSC) will support the planning, initiation, execution, and closeout of clinical studies across Propedixs 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 requirements
Ensure studies are conducted in accordance with GCP, FDA regulations, and applicable guidelines
Support 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: Bachelors 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 their administrative supervisor and will also work closely with clinical vendors and the formulation team.