Ophthalmology Clinical Research Coordinator / Technician / Assistant

at  East Coast Institute for Research

COME WORK WITH A GROWING, MULTI-SITE CLINICAL RESEARCH TEAM!

East Coast Institute for Research (ECIR) is dedicated to developing ground-breaking new research to benefit our communities. Our research involves the latest medications and devices not yet available to the general public and is conducted at our state-of-the-art facilities in Northeast Florida, Georgia, and Tennessee. With over 15 years of experience, ECIR maintains a positive reputation with our sponsors, our partnering clinics and our patients.
We currently have 9 research sites and continue to grow! We’re a small, family-oriented company that cares about our employees and provides an environment where learning and growth is available and encouraged. We have a clear growth plan for our clinical research staff and offer reimbursement for the credentialing process as well as other training to help our clinical staff feel prepared and successful.
We offer great health benefits that are available in less than 30 days including medical (with an HSA option with company match), dental, vision, life, and disability, so that you can make sure you and your family’s health are taken care of. We also provide ample paid time off, paid holidays, and flexible schedules. Our 401K option is available to employees after 3 months and has a company match.
Engaging with each other through continued training and fun group experiences is important to us. We try to get all 9 sites together quarterly to do team building, continued education, and just have some fun!
We’ve told you about us, now tell us about you! Apply today!

OPHTHALMOLOGY CLINICAL RESEARCH COORDINATOR JOB DESCRIPTION:

Under the direction of the Research Manager and VP, this position facilitates the execution of new studies and performs consistent and ongoing coordination of ongoing studies and maintenance of open and closed studies, as applicable. This position arranges and oversees all clinical study activities and recruits patients for clinical studies. This position works in close coordination with all team Enrolling Clinical Research Coordinators, Follow-Up Clinical Research Coordinators, Clinical Research Assistants, Investigators, study monitors/Clinical Research Associates (CRAs), sponsors, Clinical Research Organizations (CROs) and the ECIR Compliance team to carry out the trial, as well as provide guidance on the administration of the compliance, financial and other related aspects of all ongoing clinical studies.
To work as an integral member of ECIR research staff maintaining the day-to-day relationship with ECIR sites and assist in the development of the ECIR network. This includes planning, coordinating and, as appropriate, execution of clinical studies in accordance with the protocol, contracted scope of work, ICH/GCP, Sponsor, CRO, and ECIR SOP’s and any relevant local guidelines and regulations.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Sound knowledge of medical terminology.
• Sound knowledge of ICH/GCP and Regulatory requirements.
• Knowledge of good clinical practice (GCP), FDA and HIPAA policies and practices.
• Knowledge of International Air Transport Association (IATA) Dangerous Goods Regulations.
• Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors.
• Proficient in the use of Microsoft Office and Excel.
• Fluent in spoken and written English language.
• Strong organizational skills and meticulous attention to detail.
• Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.
• Ability to maintain confidentiality.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

MINIMUM REQUIRED EDUCATION, EXPERIENCE AND CERTIFICATIONS

• At least 1 year of experience as an Ophthalmology Technician/Assistant/Technologist (required)
• Certified Ophthalmic Assistant (COA), Certified Ophthalmic Technician (COT), or Certified Ophthalmic Medical Technologist (COMT) (preferred)
• High School diploma
• More than 1 year of CRC experience, preferably working on industry sponsored trials or appropriate internal progression and promotion (preferred)
• Good Clinical Practice (GCP)
• International Air Transport Association (IATA)
• Maintaining License/Certification status with appropriate CEU’s, if applicable
• Cardiopulmonary resuscitation (CPR)

PHYSICAL REQUIREMENTS

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Extensive use of keyboard requiring repetitive motion of fingers.
• Regular sitting for extended periods of time.
• Occasional travel – required
  Job Type: Full-time

Benefits:

• Quarterly bonus opportunities
• Paid time off
• Flexible schedule
• Advancement opportunities
• 401(k)
• 401(k) matching
• Health insurance
• Health savings account (with company match)
• Dental insurance
• Life insurance
• Disability insurance
• Vision insurance
• Referral program

Schedule:

• Day shift - office hours are determined per research site
• Monday to Friday

OPHTHALMOLOGY RESPONSIBILITIES

• Performing procedures including Optical Coherence Tomography (OCT), Fundus photography, Electroretinography, Intraocular Lens Measurements, Amsler grids, and Visual Field Testing, Tonometry, Refractions, Corneal topography, etc.
• Troubleshooting and regular maintenance of all equipment, machines, computers, etc.
• Administering ophthalmic solutions such as artificial tears, anesthetics, dilating solutions, and prescriptions
• Assisting physicians in exams and procedures
• Performing refractions
• Testing near and distance vision, color vision, EOMs, and depth perception

RESEARCH RESPONSIBILITIES

• Coordinates with Principal Investigator (PI) and other research staff to help ensure that clinical research and related activities are performed in accordance with federal regulations and ECIR’s Standard Operating Procedures (SOPs).
• Assists the PI in development of materials and tools necessary to appropriately train research staff involved in the conduct of the study, related to (but not limited to) protocol requirements, schedule of visits, and execution of research procedures. Documents date of training and signatures of research staff trained on study specific training log.
• Cooperates with ECIR compliance and monitoring efforts and reports instances of noncompliance to the ECIR Research Manager and ECIR Director of Compliance.
• Coordinates and facilitates monitoring and auditing visits. Notifies ECIR Research Manager and ECIR Director of Compliance of external audits by FDA, sponsors, and Clinical Research Organizations (CROs).
• Collaborates with PI and ECIR to respond to any audit findings and implement approved recommendations.
• Attend and participate in investigator meetings, monitoring visits, audits, seminars, and other regional or national meetings as required or requested.
• Collaborates with the PI and ECIR Compliance team to prepare Institutional Review Board (IRB) and any other regulatory submission documents as required by the protocol.
• Works with the ECIR Compliance team in the collecting of study documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, Financial Disclosure Forms, CVs, etc.)
• Organizes and maintains filing in all study files, including but not limited to, regulatory binders, study specific source documentation, and other materials.
• Coordinates and attends Site Initiation Visits (SIVs), Interim Monitor Visits (IMVs), and Close Out Visits (COVs).
• Reviews and develops a familiarity with the protocol, e.g., study procedures and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
• Works with the PI and ECIR to develop and implement recruitment strategies in accordance with IRB requirements.
• Conducts or participates in the informed consent process including discussions with research subjects, including answering any questions related to the study. Obtains appropriate signatures and dates on informed consent forms (ICFs) in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
• Creates study specific source documentation templates utilizing the study protocol, study Case Report Form (CRF) or electronic CRF screenshots, ECIR SOPs and GDs, and other provided resources prior to the SIV.
• Prepares study subject research binders by gathering, creating, and including necessary forms, logs, and study source document templates to prepare for subject enrollment.
• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential subject’s eligibility or exclusion.
• Registers subjects to the appropriate coordinating center (if multi-site study), such as through the Interactive Web Response System (IWRS).
• Coordinates subject’s physical exams with appropriate study investigators and other tests and procedures required by the study protocol.
• Collects data as required by the protocol. Assures timely completion of Case Report Forms.
• Completes study documentation and maintains study files in accordance with sponsor requirements and ECIR SOPs and GDs including, but not limited to, consent forms, source documentation, case report forms, and investigational product accountability forms.
• Performs specimen processing and shipment of biological specimen duties.
• Perform functions necessary for successful completion of all protocol required visits/procedures such as vital signs, phlebotomy, diagnostic tests, dispensing of investigational product, scheduling, drug accountability/reconciliation and organizational tasks, where appropriate and as delegated by the PI, in accordance with local country requirements and licensures.
• Accurately completes source documents and case report forms in both paper and electronic format.
• Performs timely submission of study visit data into the Electronic Data Capture (EDC) system, if applicable.
• Assists investigators with recording and reporting of adverse events (AEs) and Serous AEs (SAEs) within appropriate timeframes as per the study protocol, IRB, and local regulatory authority guidelines.
• Schedules study participant appointments and serves as the patient liaison to the PI and other participating investigators.
• Performs study visit reminder phone calls to study subjects for upcoming research appointments.
• Requests Medical Records, certify prints Medical Records from clinic Electronic Medical Records (if applicable), and extracts data from patient records in a timely manner.
• Distributes Dear Doctor Letters, informing research subject’s primary care physicians of their participation in the research study, as requested by the study subject.
• Responds to data clarification requests and queries in a timely manner, according to the study protocol and ECIR SOPs and GDs.
• Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or ECIR SOPs and GDs on Investigational Product Accountability.
• Maintains effective and ongoing communication with sponsor, CRO, research subjects, and PI during the course of the study.
• Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management.
• Assists the PI in promptly reporting any unanticipated problems involving risks to research subjects or others to the IRB.
• Assists the PI in submission of accurate and timely closeout documents to the IRB, sponsor, CRP and other agencies in accordance with federal regulations and ECIR SOPs and GDs.
• Registers each subject visit in the ECIR Clinical Trial Management System (CTMS), Clinical Conductor in a timely manner to ensure billing of study procedures to the appropriate funding source.
• Writes Standard Operating Procedures (SOPs) and Guidance Documents (GDs), reviewed by the Research Manager and VP of Clinical Operations.
• Conducts presentations at ECIR Company Trainings as requested.
• May perform other job-related duties as requested or required.