1. May 20, 2014
2014 Summer Intern Position: Business Support Specialist (BSS)
Experience requirement: Knowledge of Synergy systems and processes are preferred.
Deliverable: Assist Synergy in its organization and set-up of the Archiving Room and
electronic archiving files. These activities include but are not limited to unpacking and
filing of boxes that contain study records, and organize the clinical study TMF for past
and ongoing studies to be archived. The BSS will conduct quality check of paper
nonclinical final study report to CD version and verify against electronic trial Master File
copy. BSS will identify and inventory records for long term storage at Iron Mountain. In
addition, the BSS will assist with the preparation of regulatory submission (e.g., prepare
paper copies for EOP2 IBS-C meeting). Participate in Quality Assurance reports/
questionnaires reviews and update QA tracking database. Assist in Monitoring Report
Surveillance program. Support Clinical Operations to review and track CRO and vendor
portals for patterns of non-compliance for the OLE/CIC/OIC Studies. Assist in ad hoc
clinical trial activities – on an as needed basis.
BSS will provide a brief written summary of knowledge gained at the conclusion of the
summer internship.
BACKGROUND: This is an ongoing summer intern program that was initiated in August
2012. This year additional renovations were done to the Synergy office. A new archive
room was constructed and a filing system needs to be put in place. In addition, Synergy
has instituted a Monitoring Report Surveillance Support program as part of CRO oversight
in part to identify non-compliance for the OLE/CIC/OIC Studies. In addition, other CRO
oversight and clinical inspection readiness activities are being added as we formalize the
CRO oversight activities.
RECOMMENDATION: Our past summer intern – Natasha and Luke (2 year and 4 year
college, respectively) are familiar with the Synergy TMF process and procedure for
inventory and archiving. This is an important task for Synergy and we must move forward
with the reconciliation of the paper data against the electronic and preparation for storage
at Iron Mountain.
Hourly wage: $15.00/hr. – minimum 3 day work week.