Clinical Study Coordinator/Manager

Job Description

Job Description

Job Description – Clinical Study Manager/Coordinator

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 : Clinical Study Manager or Coordinator

Position Overview:

The Clinical Study Manager or Coordinator (CSM or 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 (30 hours/week), hybrid (on-site and remote), 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

· Track and report key study performance metrics, including enrollment targets, retention rates, and milestone progress, and implement strategies to address gaps or delays

· Lead participant recruitment efforts, including screening for eligibility, explaining the study, and facilitating enrollment

· Obtain and document informed consent from study participants in accordance with GCP, IRB requirements, and the study protocol

· Manage patient visits, including scheduling, data collection, and source documentation

· Ensure protocol adherence, track protocol deviations, and troubleshoot operational challenges

· Support and conduct site initiation training on protocol procedures, workflows, and GCP standards

Data Collection & Quality Management

· Oversee accurate and timely completion of case report forms (CRFs), including paper-based systems

· Demonstrate familiarity with common clinical trial systems and tools, including electronic data capture (EDC) platforms, clinical trial management systems (CTMS), and hybrid workflows integrating paper-based CRFs with electronic 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: Candidate must live in the greater Boston MSA and within 30 minute drive to 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.

Experience/ Necessary Skills

Education: Bachelor’s degree in STEM discipline

Experience:

Required:

· 2+ years (CSC) and 5+ years (CSM) of experience coordinating clinical trials, including site management and regulatory processes

· Familiarity with GCP, FDA regulations, and IRB procedures

· 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 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

Hours: Approximately 30 hours per week. Candidates are required to attend a company-wide meeting on Tuesday evenings. This role follows a hybrid schedule, consisting of three in-person days and one remote day per week. A flexible schedule is required, including availability for occasional evening and weekend work, with the ability to complete certain responsibilities remotely as needed.

Compensation: $35 to $40/hr for CSM and $25 to 30/hr for CSC. 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.

Application: Interested parties should send their resume and a brief cover note to [email protected].