University of Rochester Clinical Research Coord (S) - 214085 in Rochester, New York
Clinical Research Coord (S)
School of Medicine & Dentistry
Full Time 40 hours Grade 051 Neuro-Ctr Health & Tech/CTCC
8 AM-5 PM; OCC WKENDS
The responsibility of the Clinical Project Coordinator, Assistant is to help coordinate all aspects of multi-center international clinical research trials.
Under general guidance and with latitude for the exercise of independent judgment and initiative:
Develops draft informed consent documents utilizing Standard Operating Procedure Templates under the direction of the Team Leader (Senior or Associate Project Manager). Assists with reviewing site informed consents and may advise sites on revisions based on the model consent under the direction of the Team Leader; ensures that site changes are acceptable and notifies sites when consent forms are in an acceptable format for IRB submission. Tracks in regulatory document spreadsheet dates of draft consent receipt from the sites and their approval dates; files correspondence pertaining to the review and approval process in site file.
Under direction of Team Leader, processes requests for, reviews for accuracy and content, tracks receipt of, and carefully safeguards applicable paper and electronic regulatory documents for clinical trials, including but not limited to, signed curriculum vitae, professional licensure, and certification of human subjects protection and good clinical practice education as per Standard Operating Procedures. Maintains a central file and tracking of professional licenses, human subjects protection and good clinical practice training certification for all active site personnel. Collaborates with Team Leaders to ensure that CTCC study file content and format are consistent with Good Clinical Practice, applicable regulations, and Standard Operating Procedures.
Utilizes internal tracking system to monitor upcoming IRB expirations and contacts sites to obtain renewals. Reviews documents received (approval letter, current approved consent) to ensure letter delineates what has been approved and ensures approval is applicable to all necessary documents.
Under direction of Team Leader and per Federal Regulations, Good Clinical Practice and Standard Operating Procedures, drafts site communication during study start up and throughout study maintenance phase, assists in drafting site communication plan to sites regarding study closeout and archiving processes to be followed. Assists with file archiving of CTCC administrative study specific files in a centralized Document Archive Center to ensure secure storage and retrieval for the custody of study documents.
Under direction of Team Leader, processes requests for information and documentation from functional groups (e.g., Data Management and Biostatistics) and compiles information in report-ready format. Works with Team Leader to compile information, collate and paginate grant submissions.
Bachelor’s degree, with major course works in appropriate health, social science, or biological science field; or equivalent combination of education and experience. Knowledge of Good Clinical Practice, protocol planning, implementation, coordination, evaluation, and reporting of clinical trials preferred. Clinical trials project management experience preferred. Some travel may be required. Strong oral and writing skills and attention to detail required.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled