Clinical Research Coordinator C

University of Pennsylvania•Institute, WI

1d•$62,000 - $65,000

About The Position

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.

Requirements

COT certification
5 or more years of experience as ophthalmic technician
electronic medical record experience (EPIC training a plus)
Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.

Nice To Haves

specializing in cornmeal disease a plus

Responsibilities

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
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).

Benefits

Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare.
You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
Penn provides an array of resources to help you advance yourself personally and professionally.
As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.