Retina Specialist

Position Summary:

The Retina Specialist (MD) will serve as a sub-investigator, progressing to principal investigator, at (Login for Information), a high-volume vitreoretinal clinical research site within Lexitas Pharma Services. The physician provides study-related patient evaluation, procedural and surgical study interventions, safety oversight and medical judgement across trials of retinal therapeutics, gene and cell therapies, sustained-delivery devices, imaging and diagnostics. The role begins as a part-time on-site commitment (1 to 3 clinic days per month) with a defined path to full-time, and combines on-site investigator duties with remote investigator work (protocol and feasibility review, eligibility and imaging review, safety follow-up, EDC sign-off, sponsor and monitor calls).

Position Responsibilities:

On-site (Erie)

 • Serve as Sub-Investigator, then Principal Investigator, on ophthalmic clinical trials; listed on FDA Form 1572 and delegation logs for assigned studies.

 • Conduct protocol-specified patient evaluations: dilated retinal examination, OCT / OCT-A, fundus photography and fluorescein angiography interpretation, eligibility confirmation, endpoint assessment.

 • Perform study procedures permitted by protocol: intravitreal injections, intravitreal implants and sustained-delivery devices, suprachoroidal injections, anterior-chamber sampling, laser.

 • Perform or assist surgical study procedures (subretinal and suprachoroidal delivery, vitrectomy-based interventions) at the affiliated operating room / surgery centre when the protocol and credentialing permit.

 • Provide safety oversight for research participants: adverse event and serious adverse event assessment, causality, documentation and reporting within protocol and regulatory timelines.

 • Attend site initiation, interim monitoring and close-out visits as required; support sponsor and CRO audits and regulatory inspections.

 • Provide high-quality clinical care and follow-up for research participants; collaborate with coordinators, technicians, imaging staff and the site quality function.

Remote (from any location)

 • Protocol, feasibility and budget-relevant medical review for new studies; eligibility pre-screening and imaging review on the site EMR / eSource platform.

 • Query resolution, EDC and eSource electronic signatures, safety follow-up documentation, medical monitor and sponsor calls, investigator meetings and protocol training.

 • Masked grading and adjudication work for Lexitas reading-centre programmes, as assigned and with appropriate masking.

 • Support ERR and Lexitas network growth: sponsor feasibility, site qualification visits, scientific presentations and publications arising from site data.

Compliance

 • Maintain compliance with ICH-GCP (E6), 21 CFR Parts 50, 56, 312 and 812, HIPAA, site SOPs and sponsor requirements; complete and maintain GCP, human-subjects and IATA training.

 • Ensure accurate, timely and attributable EMR, eSource and EDC documentation.

Position Qualification Requirements

Education:

Doctor of Medicine (MD) with residency in Ophthalmology.

*Experience:

• Fellowship training in Vitreoretinal Surgery (surgical retina) required.

• Unrestricted Pennsylvania medical licence, or eligibility with licence in process at start (out-of-state licensure supported by the site).

• Board Certified or Board Eligible in Ophthalmology (ABO).

• Clinical research experience as Sub-Investigator or Principal Investigator preferred; academic appointment and surgical-education experience valued.

• Current or prior participation in industry-sponsored retina trials (anti-VEGF, complement, gene therapy, sustained delivery) preferred.

Certifications:

• GCP (ICH E6) and human-subjects protection training (current, renewed per site SOP).

• IATA dangerous-goods shipping training where required by assigned protocols.

• BLS certification.

• Eligible to be covered under the site's clinical research liability insurance programme; not debarred or excluded (FDA debarment and OIG/SAM checks).