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.

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.

• 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

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.

• 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., Clinical Trials.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.

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

• Minimum 2…