Working under limited supervision and closely with the principal investigator(s), coordinate the study activities for the Vision Research Coordinating Center (VRCC) and the Visual Sciences Research Center (VSRC) within the Department of Ophthalmology. Responsibilities include the recruitment and retention of subjects, protocol compliance, regulatory documentation, Institutional Review Board (IRB) submissions, study budget and coverage analyses, human subject protection, and the promotion and growth of the center.
1. Work closely with the principal investigator on the various clinical research projects in the VRCC.
2. Coordinate start-up activities including coordination of study initiation meeting with sponsor and compose IRB submissions including IRB checklist, research plan, and informed consent.
3. Implement new study protocols which includes coordination of required study procedures (coordinate ophthalmic examinations, history and physical examinations, laboratory requirements, etc.), use of the institution’s investigational pharmacy, shipment and storage of study medications and supplies, availability of certified technicians and photographers, and coordination of investigator schedules
4. Evaluate and recruit study participants through internal chart reviews and physician referral, screen subjects for eligibility by evaluating protocol inclusion/exclusion criteria, interview potential participants, and obtain subject’s informed consent according to Office of Human Subject Protection guidelines discussing the risks, benefits, and alternatives of participating in research
5. Perform patient care clinical research activities: visual acuity testing, corneal pachymetry, administration of eye drops, and dispensing of study medications for study participants
6. Implement study procedures and tracking mechanisms to ensure participant evaluations at appropriate intervals, and promote subject compliance by providing support and education following the goals and plans established by sponsors, investigators and research manager
7. Identify adverse events, submit required documents to sponsor and IRB office, and track study participants for adverse event outcomes
8. Develop and submit reports for protocol changes and addenda, safety reports, and continuing renewals as required for each ongoing study to the IRB
9. Complete study charts for each study participant to meet the standards and requirements of the sponsor, IRE office, and FDA with 100% accuracy.
10. Act as liaison between study sponsors, clinical research organizations, clinical research associates (study monitors), and local IRE office coordinating site visits and providing accurate chart information, adverse event reports, information for data queries, information for internal and/or external audits as required for each study and each study participant
11. Maintain calendar as required by each assigned study and each investigator for dedicated participant appointment times, ensuring participants are scheduled within the established windows for testing and visits and meet the protocol requirements.
12. Attend annual and sponsor-requested local, national and international meetings
1. Facilitate patient access to investigators by serving as the primary contact for all study participants and triaging calls as needed
2. Develop reports and tables documenting recruitment, retention, adverse events of study participants for submission to the Investigators and Department Chairperson
3. Arrange for study participant compensation through the institution or sponsor as agreed upon in study contracts
4. Coordinate scheduling for non-departmental studies requiring ophthalmic examinations
5. Perform other duties as assigned.
Department: Contact with the principal investigator, chair, business manager and grants administrator.
University: Contact with other principal investigators, project coordinators.
External: Contact with study sponsor contacts and personnel
Students: Contact with student assistants in the VRCC
May supervise students and technicians
Experience: 3 to 5 years of experience in a medical or research setting. Clinical research working with IRB offices or other clinical research enterprises preferred.
Education/Licensing: Bachelor’s degree
Professional and effective oral and written skills and strong interpersonal skills required. Must demonstrate excellent writing skills and the ability to work with various individuals within and external to the university.
Ability to educate/train staff effectively (required)
Ability to manage the coordination of multi-center project within the VRCC ensuring that all federal and local protocol requirements are met (required).
Knowledge of good clinical practices (required).
Strong organization skills; ability to multi-task, prioritize and meet deadlines. Must demonstrate attention to detail and accuracy, time management skills, and proven ability to successfully follow-through on assigned projects.
Ability to work effectively independently and collaboratively within a team. (Must be highly motivated, responsible, dependable and a self-starter.
Proficiency in Microsoft Office (ex: Word, Excel, PowerPoint, Access, Publisher), database applications, and with internet navigation.
Must demonstrate willingness to learn new techniques, procedures, processes, and computer programs as needed
This job is performed in an office setting with time in clinical offices. There are no/specific hazards associated with this position.
In employment, as in education, Case Western Reserve University is committed to Equal Opportunity and Diversity. Women, veterans, members of underrepresented minority groups, and individuals with disabilities are encouraged to apply.
Case Western Reserve University provides reasonable accommodations to applicants with disabilities. Applicants requiring a reasonable accommodation for any part of the application and hiring process should contact the Office of Inclusion, Diversity and Equal Opportunity at 216-368-8877 to request a reasonable accommodation. Determinations as to granting reasonable accommodations for any applicant will be made on a case-by-case basis.
Case Western Reserve University - 8 months ago