"Clinical Research Coordinator C"

Job Description Summary

This position will be a resource for best practices of managing major clinical trials. The coordinator will provide guidance to both study trials and device trials. The incumbent will be a liaison to departmental interaction such as the investigational team, and sponsor. They will be a resource to other members of the team and will oversee the implementation of new clinical trials. Will review all new trials to help identify the challenges and opportunities discovered. Will problem-solve the challenges to implement a plan of action. Work with the regulatory manager to ensure that submissions to the IRB are completed in a timely manner.

Job Description

• Provide assistance to investigators with ocular examination, coordination of clinical trials, including recruiting new patients, maintaining high retention levels, interviewing participants, gathering medical data, coordinating visits with, interdepartmental units ( retina /neurology, ) PI/Photographers and laboratory personnel, completing records expeditiously,
• Interact with governmental regulatory agencies regarding human subject research, completing regulatory submissions to the IRB and monitoring compliance with all institutional regulatory guidelines.
• Maintain patient department research shared drive/BOX regarding study, documentation, enrollment logs and visit summaries.
• Complete study abstract for inter-departmental research departments requiring ophthalmology services, determine facilities/equipment are available to complete required visits per the protocol required findings, distribute abstract to requesting department/ ophthalmologist/research team, confirm ICF includes required wording for required ophthalmology exam and testing, schedule appointments including emergency visits as required, track patient visits/procedures, follow-up on SAE and AE findings with requesting department, submit orders for protocol require testing, submit visit/procedure tracking documentation to department BA on a monthly basis, work with outside departments on the development of EPIC Smart Set to document exam and protocol requirements, work with ophthalmologist to confirm all required testing is performed and patient meets ocular inclusion/exclusion per study protocol.
• Collaborate with other investigators internally and at inter-departments and institutions.
• Perform ophthalmic testing and exams for non-COT certified coordinators
• Train CRC on performing ophthalmic testing procedures
• Act as resource for clinic staff and investigators for problem resolution
• The ability to perform all ophthalmic diagnostic testing per protocol, including protocol refractions, protocol specific visual field testing ophthalmic imaging, and experimental device testing on clinical research patients seen within the department of Ophthalmology.
• Assist ophthalmologist with experimental ocular procedures performed in short procedure unit or exam room.
• Review, organization, and upkeep of all current Ophthalmic Exam and imaging protocols providing clear communication of these requirements to participating clinical staff, and physicians.
• Assist with full diagnostic research certifications of both equipment and performance for all ophthalmic studies requiring certification to perform diagnostic testing.
• Serving as liaison between the equipment vendors the use of software to transmit images/results to reading center), reading centers, participating clinical staff, and clinical research investigators.
• Traveling to PCAM/ Scheie Ophthalmology department locations where research and clinical trials are performed

Summary of Accountabilities:

Certified Ophthalmic Technician/Research Coordinator:, Critical thinking skills a must, Penn CRC Certification within three months of hire date, EPIC Training which includes ( Penn Chart Research, Registration Remediation, Schedgistration Registration Training, Billing Compliance) CTMS, CITI for Human Research Certification, HIPPA Certification, GCP Certification, Blood Bourne Pathogens Training, phlebotomy and IV certification, Financial Conflicts of Interest Training Course , IRB submission and revisions

• Provide assistance to investigators with coordination of clinical trial, including recruiting new patients, maintaining high retention levels, interviewing participants, gathering medical data, performing slit lamp exams, coordinating visits with PI/ Photographers, interdepartmental CRC/investigators, laboratory personnel, radiology, completing records expeditiously.
• Responsibilities require performing a preliminary examination on all patients (per protocol, when applicable), which include but are not limited to, a complete medical and ocular history, visual acuity, protocol refraction. Diagnostic duties include performing anterior segment ophthalmic exam and imaging per study protocol, obtaining reading center certification for each study, transmittal of images to imaging to reading center, and additional duties as needed.
• Will assist in the execution of study activities with the staff to ensure adherence to the protocol is followed. Will support monitoring and auditing of compliance and enrollment which include a review of the data entry for accuracy and completeness and adverse event management. S/he will provide frequent updates to the research team and the director. The research coordinator provides oversight of multi-departmental studies by auditing sub-site data and research materials (protocols, investigator brochures, consents, case report forms, certifications, regulatory materials, protocol compliance etc.) and coordinates with sub-site research personnel to ensure patient safety and data integrity.
• Participate in the informed consent process of study subjects. Support the safety of the clinical research participants. Coordinate protocol related research procedures, study visits, and follow-up care. Screen, recruit and enroll patient's/research participants. Maintain study source documents. Report adverse events promptly. Provides oversight in the preparation, management, and monitoring of study budgets (including creating PRAs and sending them to appropriate grants personnel).. Prepares study sites for internal/external regulatory audits (sponsor, FDA, NIH, etc).

Equipment:

Diagnostic for research studies: Confocal corneal microscopy, corneal endothelial cell count, corneal and retinal OCT (optical coherence tomography), corneal topography, DSLR (digital single lens reflex) cameras, fundus cameras, slit lamp cameras, Lipaview, Keratograph, micro perimetry and experimental ophthalmic imaging devices.
Technician: Auto-refractor, blood pressure machines, color plates, , ETDRS (early treatment diabetic retinopathy study) chart, individual trial lenses, pachymeter, slit lamp, Humphrey Visual field analyzer, slit lamp, and Goldmann tonometer

Certification:

COT, Protocol Certifications for all imaging study protocols, protocol refraction and visual acuity certification as needed for study protocols, micro perimetry, phlebotomy and IV.

Experience Requirements: COT certification, 5 or more years of experience as ophthalmic technician, electronic medical record experience (EPIC training a plus), specializing in cornmeal disease a plus. Other duties and responsibilities as assigned

Qualifications

Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required. This position is contingent upon grant funding.

Job Location

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$62,000.00 - $65,000.00 Annual Rate