Working title:

STUDY COORDINATOR - OPHTHALMOLOGY

Official title:

SR RESEARCH SPEC(T16BN) or RESEARCH SPECIALIST(T16DN) or ASSOC RESEARCH SPEC(T16FN)

Degree and area of specialization:

BA/BS in biological or health sciences or psychology

Minimum number of years and type of relevant work experience:

1-2 years
Required experience:
- Demonstrated ability to understand and interpret complex protocols, regulations or policies
- Use of network-based data bases
- Computer proficiency including ability to work with web-based systems

Desired Experience
- Experience with IRB or GXP or federally regulated research
- Post baccalaureate research and or teaching experience

The person in this position must possess excellent problem solving, interpersonal, written and oral communications skills. Must also have strong organizational skills and ability to work independently essential.

Principal duties:

50% Quality Standard Management
Manage quality of submissions of source data (digital or film based images and retinal scans) and source documents from external sources.
- determine pass/fail by applying study-specific criteria for assessment of quality of submission
- if pass, oversee release of images for processing and grading
- if fail, determine criticality of failure based on interpretation of protocol and procedures
- implement remediation, in collaboration with faculty PI as appropriate
- documentation of failures, develop remediation plan and timeframe for resolution

Independently monitor external site performance by monitoring failures
- analyze causes of failure to identify areas where site personnel reeducation is needed
- initiate remediation by communication with site personnel and clinical investigators as appropriate
- report analysis of failures to FPRC administrators, faculty, PI, and pharmaceutical company or federal or academic sponsors
- analyze individual site performance and recommend areas where quality improvement is needed

Independently review sponsor's clinical investigative protocol to write initial IRB application
- apply rules/specifications for FPRC submission of clinical protocols as defined by Health Sciences IRB to determine type of submission and to identify study-specific elements in addition to the required protocol
- maintain IRB approval for study
- analyze protocol amendments
- IRB reporting as required

Write project specifications based on sponsor's protocol
- collaborate with faculty PI and lead the project team to identify grading and photographic procedures

Initiate and oversee maintenance of study specific project log as central repository for all documentation as mandated by federal regulations for clinical trials.
- perform periodic audit/review of project logs
- document all deviations or discrepancies by written analysis of impact and resolution

Monitor project scope of work to identify deliverables and timeline
- analyze changes in sponsor's timeline/deliverables for impact across workgroups and on budget
- analyze study workload projection versus actual
- evaluate criticality of deviations
- collaborate with work groups to re-engineer workflow and processes as needed

Analyze internal process for each study to identify deviations from FPRC SOPs.
- report all deviations to QA for documentation and resolution
- collaborate with QA

30% Project Management
- set priorities for workflow for program assistants for image inventory function
- set priorities for digital images processors
- analyze audit-readiness of projects

20% Client Management
- participate in clinical site physician and research staff education by making formal and informal presentations of FPRC processes in general at regional, national and international meetings and through ongoing resolutionof queries
- create training presentations specific to the study for clinical site personnel, sponsor site monitors, and photographers
- serve as point of contact for federal or corporate sponsors for services outside of the scope of work for the project
- answer protocol- and procedure-specific questions for extramural investigators and investigators and and coordinators as well as FPRC faculty and staff
- participate in audits by sponsor regulatory specialists through providing orientation to general and specific relevant FPRC procedures, and demonstrating study-specific documentation of processes as required by federal regulations

Additional Information:

Position title prefix is determined by the type and number of years of professional related work experience.

TO ENSURE CONSIDERATION

Application must be received by: MAY 19, 2008

HOW TO APPLY:

Unless another application procedure has been specified above, please send resume and cover letter referring to Position Vacancy Listing #58752 to