Responsible for functioning as a site study coordinator by managing sponsor interactions with external collaborating clinical research sites as part of the St. Jude Collaborating Study Sites Office (CSSO): provides St. Jude IRB-approved protocol documents to the sites, reviews site documentation of IRB approval; monitors and tracks contracts and institutional site proposal packets for timeliness and completion; regularly communicates with sites and St. Jude study team to identify and resolve issues or problems; works with principal investigator and study staff to develop study in-service programs and assists in study initiations, monitoring visits and study closure visits for collaborators; reviews informed consent documents for regulatory compliance and facilitates clinical review of informed consent; organizes and schedules clinical study site initiation meetings; oversees site progress, ensures amendments, revisions and continuing reviews are submitted and approved appropriately at each site; maintains essential documents for each collaborating study site, tracks the currency of the information to ensure compliance with regulations; trains each collaborating site in the use of the institutional regulatory document repository and exchange of documents for review and revision using the repository. Customizes assessments of potential sites and works with St. Jude departments to coordinate collaborative activities. Develops and maintains departmental and institutional collaborating sites databases. Manages St. Jude interactions with the study sites before study activation and during study participation. Supports clinical research education efforts pertaining to external collaborating clinical research sites. Facilitates the distribution and completion of required forms to add a collaborating site. Collects and maintains essential regulatory documents to ensure compliance with Good Clinical Practices, International Conference on Harmonization (ICH) guidelines, and federal regulations for investigational products and St. Jude policies. Develops and maintains study specific document and data sharing systems for collaborating sites and St. Jude staff. Maintains CSSO database for transparency and accurate tracking of site status and information.
Requires two (2) years of direct experience in clinical biomedical and/or behavioral research.
This position also requires experience or background in each of the following:
Requires a Bachelor’s or foreign equivalent degree in a related biomedical/behavioral field.
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