Philadelphia, PA: Part-time/full-time Ophthalmology Trial Coordinator Needed
Budget: $250 – $750 USD
I’m running a series of ophthalmology clinical trials and need an experienced research coordinator to keep everything on track from first patient contact through database lock.
Scope of work
• Recruit and enroll eligible participants in accordance with IRB-approved protocols.
• Collect and manage data from patient medical records, laboratory results, and imaging studies, entering it accurately into the study EDC/CTMS (REDCap, OpenClinica, or a similar platform).
• Monitor ongoing compliance—visit schedules, informed-consent documentation, adverse-event reporting, and source-to-CRF verification—so each site passes internal QA and sponsor audits.
What I’m looking for
• Proven coordination experience in ophthalmology trials (AMD, glaucoma, diabetic retinopathy, or similar).
• Solid grasp of GCP, FDA 21 CFR Part 11, and ICH guidelines, although will not primarily be responsible for regulatory operations.
• Comfort working with EMR systems (CRIO, Florence), imaging software (OCT, fundus photography), and basic statistical tools for interim data review.
• Strong communication skills to liaise with investigators, sponsors, and site staff.
Deliverables & milestones
1. Participant recruitment report with screening/enrollment logs.
2. Clean, validated datasets for medical records, labs, and imaging.
3. Monthly compliance summary highlighting deviations and corrective actions.
4. Close-out package ready for sponsor submission.
If you can jump in quickly (we have one clinical site and multiple active trials), and maintain meticulous documentation, let’s talk—our first enrollment window opens soon.
Scope of work
• Recruit and enroll eligible participants in accordance with IRB-approved protocols.
• Collect and manage data from patient medical records, laboratory results, and imaging studies, entering it accurately into the study EDC/CTMS (REDCap, OpenClinica, or a similar platform).
• Monitor ongoing compliance—visit schedules, informed-consent documentation, adverse-event reporting, and source-to-CRF verification—so each site passes internal QA and sponsor audits.
What I’m looking for
• Proven coordination experience in ophthalmology trials (AMD, glaucoma, diabetic retinopathy, or similar).
• Solid grasp of GCP, FDA 21 CFR Part 11, and ICH guidelines, although will not primarily be responsible for regulatory operations.
• Comfort working with EMR systems (CRIO, Florence), imaging software (OCT, fundus photography), and basic statistical tools for interim data review.
• Strong communication skills to liaise with investigators, sponsors, and site staff.
Deliverables & milestones
1. Participant recruitment report with screening/enrollment logs.
2. Clean, validated datasets for medical records, labs, and imaging.
3. Monthly compliance summary highlighting deviations and corrective actions.
4. Close-out package ready for sponsor submission.
If you can jump in quickly (we have one clinical site and multiple active trials), and maintain meticulous documentation, let’s talk—our first enrollment window opens soon.