Clinical Trial Project Manager

Job Description Job Description Clinical Trial Project Manager Employer: Family Eye Care, Inc., dba Vision Source of Worcester and Spencer Location: Worcester, MA (on-site at Vision Source of Worcester), with possibility for travel to other practice locations in Spencer or Charlton MA, or brief site visits to participating clinical sites nationally. Remote work approved up to 3 days per week on a case-by-case basis with prior approval. Employment Type: Full-time (5 days/week). Reports To: Kevin Houston, OD, MSc, Principal Investigator / Chief Scientific Officer (for clinical trial duties); Practice Management Lauren Thamel (for in-practice duties) Compensation: Up to $90,000/year depending on experience and performance benchmarks. Includes a $5,000 sign-on bonus and performance-based incentives paid out over the course of the ~3-year project as milestones are met. Position Summary We are seeking an experienced Clinical Trial Project Manager to lead day-to-day coordination of this multicenter study, while also contributing to the broader optometry practice in a cross-trained support capacity. Reporting to the Principal Investigator for clinical trial responsibilities, the Project Manager will serve as the operational hub connecting the coordinating site with participating clinical sites nationwide, driving the trial from site activation through study close-out. As trial activities allow, this person will also work alongside practice staff, cross-trained according to their skills and interests. This is a great opportunity for someone looking to work at the intersection of clinical research and patient care, as part of a supportive 3rd generation family-owned small business.

We're looking for someone who is: - Friendly, professional, and patient-focused - Highly organized, detail-oriented, and comfortable managing multiple deadlines at once - Dependable and punctual - Comfortable with computers, data systems, and learning new software - A strong team player with a positive attitude - Curious and willing to learn new areas of both clinical research and patient care

About the Project Vision Source of Worcester has been awarded an NIH SBIR Phase II grant to conduct a multicenter randomized crossover trial comparing two non-surgical treatments for severe blepharoptosis (drooping eyelid): the Magnetic Levator Prosthesis (MLP), a custom 3D-printed device, and the Kinesiotape Frontalis Sling (KTFS). The study will enroll subjects across up to 8 clinical sites nationally, operating under a single IRB of record (UCLA IRB) via the SMART IRB reliance system. Clinical Trial Project Management Duties (Primary Focus)

* Assist the Principal Investigator in the overall day-to-day management of the multicenter trial * Coordinate patient recruitment and enrollment activities across all participating sites * Track protocol adherence across sites and help resolve protocol deviations * Coordinate the schedule of study visits and monitor enrollment/visit-completion timelines against the study's schedule of events * Manage data transfer between participating sites and the coordinating site, and support preparation of data for analysis * Prepare and maintain data collection instruments * Assist with regulatory approvals, IRB reliance/authorization agreements, and clinical trial registration (e.g., ClinicalTrials.gov) * Track Clinical Trial Agreement execution status at each site and coordinate with participating sites' research administration offices * Maintain the regulatory binder/eRegulatory system: protocol versions, informed consent forms, IRB approvals and amendments, training records, and delegation logs * Track participant enrollment progress at each site against targets * Perform direct data collection responsibilities for the lead site * Coordinate device and supply logistics to participating sites (fitting kits, tape supplies, recording devices, prescription lens orders) * Support internal and external reporting, including sponsor progress reports * Contribute to results dissemination, including manuscript and conference preparation support * Grant reporting * Grant preparation and submission for future projects * Identification of new clinical trial site opportunities for the practice.

Practice Support Duties Cross-training will be assigned based on the successful candidate's existing skills and interests, and may include any combination of:

* Ophthalmic/optometric pre-testing and other technician duties * Front desk support, including scheduling and patient check-in/check-out * Eyewear/glasses assembly * Vision therapy support

Required Qualifications

* Minimum 2 years of experience in clinical trials project management * Strong working knowledge of Good Clinical Practice (GCP), IRB processes, and human subjects research regulations * Demonstrated experience coordinating multi-site clinical trials * Excellent organizational skills and the ability to manage multiple concurrent site-level workstreams * Strong written and verbal communication skills for correspondence with site investigators, research administrators, and funding-agency contacts * Proficiency with standard data-collection/EDC tools (e.g., REDCap) and Microsoft Office/Google Workspace * Familiarity with AI-support tools that improve efficiency * Willingness to cross-train and work regularly in a clinical optometry practice setting alongside research duties; no prior optometric/technician experience is required — training will be provided

Preferred Qualifications

* CCRP (SOCRA) or CCRC (ACRP) certification * Experience with IRB reliance systems (e.g., SMART IRB) and/or clinical trial agreement coordination * CITI training certification * Experience with NIH-funded research administration and progress reporting * Background or familiarity with ophthalmology, optometry, or stroke rehabilitation * Experience working in a small-business/SBIR-funded research environment * Prior experience in a clinical/optical practice setting (front desk, technician, or optical) is a plus but not required

Additional Details The clinical trial is funded through NIH SBIR Phase II Grant 1R44EY038558-01, currently budgeted through the end of the study's second year, with an anticipated third year pending an NIH no-cost extension. Emphasis of the position is on clinical trial project management. Total weekly hours are expected to remain full-time throughout. Some travel may be required for site visits.

To Apply Interested in joining Vision Source? Please send your resume along with a brief introduction telling us a little about yourself and why you'd be a great fit for this role to Kevin Houston " View email address on click.appcast.io Come grow with us!