Clinical Research Manager

Job Title:

Clinical Research Manager Reports To:

Managing Partner/Physician Investigators FLSA Status:

E xempt

Job Summary:

Sound Retina exists to protect vision and expand access to retinal care across the Pacific Northwest. As an independent physician owned practice, we believe that clinical and research decisions belong in the hands of physicians and their patients, free from the influence of private equity or outside corporate interests. Our research program reflects that commitment, and we are looking for someone who shares it. The Clinical Research Manager serves as the primary operational leader of the Sound Retina Research Department, overseeing all active clinical trial programs and working directly alongside our physician investigators. This role is responsible for the day-to-day management of clinical research operations including regulatory compliance, sponsor relationships, patient enrollment and retention, IRB oversight, and staff development. The Clinical Research Manager ensures that all research activities are conducted with scientific integrity, GCP compliance, and a genuine commitment to patient safety. This position requires direct hands-on experience in ophthalmic or retinal clinical research including functional and imaging testing, interventional trial management, and regulatory binder maintenance. The ideal candidate brings practical experience earned through direct patient facing research execution in an ophthalmology or retina setting and is prepared to lead a growing program with ownership and initiative. Retinal disease is one of the leading causes of irreversible blindness in the world. The work you do here matters. Clinical Trial Operations Manage the day-to-day operations of all active clinical trials across all Sound Retina locations Ensure all research activities are conducted in accordance with

GCP, FDA

regulations, and applicable federal and state requirements Maintain Trial Master Files and regulatory binders in a constant state of audit readiness Coordinate and prepare for sponsor monitoring visits, audits, and inspections Track and report adverse events, protocol deviations, and unanticipated problems in accordance with IRB and sponsor requirements Manage per patient payment schedules, budget reconciliation, and research revenue tracking IRB and Regulatory Compliance Prepare and submit IRB protocol applications, amendments, continuing reviews, and closure reports Maintain current knowledge of IRB regulations, FDA requirements, and GCP guidelines Serve as the primary regulatory contact for sponsors and CROs Ensure all research staff complete required training and maintain current certifications Monitor protocol compliance and implement corrective action plans when deviations occur Patient Enrollment and Retention Develop and implement patient recruitment strategies across the regional catchment area Screen, consent, and enroll eligible patients in accordance with protocol requirements Maintain patient relationships throughout the study period to support retention and protocol adherence Coordinate study visits, specimen collection, and data entry in accordance with protocol timelines Communicate with patients and families regarding study participation, visit requirements, and results as appropriate Sponsor and CRO Relationship Management Serve as the primary site contact for all sponsors and contract research organizations Respond to sponsor queries, data clarification requests, and monitoring visit findings in a timely manner Maintain open and professional communication with sponsors regarding site performance, enrollment progress, and operational needs Negotiate and coordinate site initiation activities including site qualification visits, training, and agreement execution Ophthalmic Testing and Clinical Support Perform or oversee ophthalmic functional and imaging testing required by research protocols including BCVA under ETDRS conditions, Humphrey Visual Field, MAIA microperimetry, and basic ophthalmic photography Ensure testing is performed in accordance with protocol specifications and quality standards Collaborate with clinical staff to coordinate research visits within the clinical workflow Support physician investigators with protocol specific clinical activities as needed Staff Development and Training Supervise and mentor research coordinators and support staff as the research program grows Develop and deliver training on research protocols, GCP requirements, and study specific procedures Support onboarding of new research staff and ensure competency in required testing and regulatory procedures Foster a culture of scientific integrity, patient safety, and continuous learning within the research team

Team Member Expectations:

Communicates effectively and respectfully with patients, co-workers, management, and providers Supports and complies with Sound Retina patient care and service standards Maintains cooperation and teamwork through positive communication and collaboration Participates in staff meetings, training activities, and professional development opportunities including ARVO and ASRS Demonstrates accountability, initiative, professionalism, and adaptability in a fast-paced research environment

Professionalism:

Maintain professional and respectful communication with patients, providers, sponsors, and staff Demonstrate strong written and verbal communication skills with professional etiquette Adhere to all organizational policies, procedures, HIPAA requirements, and compliance standards Exercise sound judgment, discretion, and confidentiality in all aspects of the role Represent Sound Retina with integrity in all interactions with sponsors, CROs, and regulatory bodies

Minimum Qualifications:

Two to five years of clinical research experience in ophthalmology or retina specifically required Bachelor of Science preferred, Bachelor of Arts acceptable Demonstrated hands on proficiency in ophthalmic functional and imaging testing (minimum BCVA under ETDRS conditions, other functional testing can be trained). Ability to exercise independent judgment, prioritize tasks, and manage a high volume time sensitive research workload Direct experience managing interventional clinical trials including GCP compliance, adverse event reporting, and regulatory binder maintenance Strong organizational, analytical, and problem solving skills

Preferred Qualification:

Masters in Public Health, or Masters in Science Experience preparing for and participating in sponsor monitoring visits and audits CCRP or CCRC certification preferred or actively in progress Experience as primary site coordinator on a Phase 2 or Phase 3 interventional retinal trial Familiarity with REDCap or similar clinical data management systems preferred Physical Demands Ability to sit and stand for extended periods of time Ability to drive to multiple sites/surgery facilities/labs (valid US driver's license, or ability to receive one) Ability to frequently use a computer, phone, scanner, and other office and research equipment Ability to communicate effectively in person and by telephone Ability to lift up to 20 pounds occasionally Ability to bend, reach, and perform light physical activity as necessary Compensation and Benefits $81,000 to $100,000 annually depending on experience. Bonus incentive program available based on further discussion. This position is eligible for benefits in accordance with Sound Retina's benefits plans and policies, including health insurance, retirement plans, paid time off, training and certification reimbursement, and other programs as outlined in company policy. Relocation assistance of up to $5,000 is available for candidates relocating from outside the greater Tacoma area. Schedule Monday through Friday. After hours work may be required depending on need/project demand. Schedule flexibility may be required based on sponsor visit and research program needs. Work Environment This position operates in a fast-paced retinal specialty and clinical research environment with frequent competing priorities and time-sensitive research deadlines. The employee must maintain professionalism, accuracy, confidentiality, and attention to detail while managing multiple active trials simultaneously. This is an in person position based at our Tacoma location. Occasional travel between clinic locations may be required. When balancing patient care and research operations, the employee must understand the patient always comes first. Equal Employment Opportunity Statement Sound Retina is an Equal Opportunity Employer and complies with all applicable federal, state, and local employment laws. Employment decisions are made without regard to protected characteristics. Canadian candidates eligible for TN visa status are welcome to apply. Sound Retina is not currently able to sponsor H-1B or other work visa petitions. The Sound Retina Research Department acknowledges that our Tacoma research program operates on the ancestral lands of the Puyallup Tribe, whose people have lived on and cared for this land since time immemorial. We acknowledge this history with respect and are committed to building meaningful relationships with the indigenous communities of the Pacific Northwest.

Pay:

$81,000.00 - $100,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Health savings account Life insurance Paid time off Relocation assistance Retirement plan Vision insurance

Work Location:

In person