Working under general direction, the project assistant provide administrative oversight of operations for the Coordinating Center staff of the National Eye Institute-funded Cornea Preservation Time Study (CPTS). The assistant will provide assistance to the CPTS Site Monitor and Coordinator with preparation of CPTS procedure manuals; pamphlet/letters; mailings, etc. The objectives of the Cornea Preservation Time Study is to determine if corneal clarity and endothelial cell loss 3 years following endothelial keratoplasty is comparable for donor corneas preserved 8 to 14 days vs. those less than 8 days. By utilizing corneas longer than one week this will allow more time to evaluate the donor corneas prior to transplantation to successfully place the donor tissue for use either in the United States or internationally, if necessary, and thus increase the donor pool. 1330 patients over a 22 month period will be enrolled at 35 sites with donors coming from 22 eye banks around the country. This is a full time position for the duration of the study..
1. Assist with preparing and distributing the Clinical Site Manual of Procedures, including formatting and editing, and distribution to all clinical sites in the CPTS.
2. Format, edit, and distribute all CC correspondence, including reports to committees and amendments to the CC manual of procedures.
3. Prepare pamphlets and letters and any other materials to be mailed to clinical sites and other parties involved in the CPTS and work with the Jaeb Center staff in Florida on coordinating information on the study to the study eye banks.
4. Arrange and facilitate meetings of the CPTS Steering Committee and Operations Committee.
5. Schedule conference rooms and arrange catering for CPTS meetings.
6. Promote retention among CPTS subjects across CPTS clinical sites by calling study patients bi-annually and distributing holiday and birthday cards to all study patients on an annual basis.
7. Answer phone calls, address inquiries and provide general administrative oversight for all matters related to the CPTS.
8. Process travel stipends and purchasing for CC. Process travel stipends to the clinical site principal investigators, coordinators and eye bank directors attending study meetings.
9. Assist CC director, principal investigator, and CC coordinator and site monitor with other CPTS administrative issues.
1. Perform other administrative functions as needed.
2. Work with department administrator and practice manager regarding institutional (CWRU & University Hospitals) procedures and protocols that need to be followed for the CPTS project to ensure research compliance among research staff. This will include assisting with updating the departmental Standard Operating Procedures (SOP) and the CPTS Manual of Procedures
Department: Frequent contact with the Coordinating Center director, Cornea Imaging Analysis Reading Center director, CPTS principal investigator, CPTS coordinator, CPTS site monitor, Vision Research Coordinating Center (VRCC) department assistant, other VRCC coordinators.
University: Occasional contact with research administration and finance and budgeting personnel.
External: Frequent contact with CPTS clinical sites across the country and related personnel, and Data Management and Analysis Center (DMAC) personnel at the Jaeb Center for Health Research in Tampa
Students: Moderate contact with students.
No supervisor responsibilities
Experience: 3 to 5 years administrative experience, preferably in administering clinical trials or other research projects
Education: High school education required; Bachelor's degree preferred
Must demonstrate professional and effective oral and written communication skills, and strong interpersonal skills in order to work with various individuals. Ability to distill important information from emails/ phone calls and other written materials.
Experience with Microsoft Office suite, especially MS Excel, Access, and Publisher
Ability and willingness to actively learn new procedures, processes, and software programs, etc., and ability to understand the implications of new information for departmental operations.
Ability to problem-solve, and demonstrate good analytical skills, good judgment and logical decision-making.
Working knowledge of common administrative practices and data management.
Excellent organizational skills; ability to multi-task, prioritize and meet deadlines. Must demonstrate attention to detail, accuracy and follow-through, and the ability to coordinate multiple events concurrently and ensure successful execution.
Ability to work independently and collaboratively within a team
Must be able to maintain confidentiality; work in a fast-paced, changing environment; and have a strong customer service focus.
General office environment. The VRCC suite is located in the University Hospitals Case Medical Center Lakeside building 4th floor. The employee will perform repetitive motion using a computer mouse and keyboard to type. The employee will also be required to travel to the various CPTS sites and eye banks around the country.
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.