The Senior Clinical Research Associate (Sr. CRA) is responsible
for assisting the Clinical Trial Manager in managing and/or leading
the day-to-day operations of assigned study execution tasks to
ensure completion per established project team goals and
objectives. The Sr. CRA will work closely with a cross-functional
team in a fast-paced high growth environment team to ensure that
clinical trials are conducted on time and budget, and in accordance
with applicable GCP/ICH guidelines and other regulatory
Participate in preparation of vendor requirements and project
scope and selection of study vendors.
Manage vendors to ensure timely and quality deliverables (e.g.
central laboratory, imaging).
Provide study progress updates to CTM and other stakeholders;
proactively identify and resolve issues that arise during study
conduct; manage escalation of study-related issues.
Provide monitoring oversight through review of monitoring
schedules, metrics and reports.
Participate in study monitoring visits, including CRA oversight
Participate in and, if appropriate, facilitate cross-functional
study execution team meetings; liaise with other functional areas
to coordinate clinical study activities.
Implement appropriate systems, standards and processes to ensure
quality at the level of investigative sites, vendors and data;
maintain clinical study files per ICH guidance.
Develop study plans and participate in system set-up (e.g. UAT
of EDC, IRT).
Participate in preparation and ensure operational excellence of
protocol, CRF, CSR and other key study team deliverables.
Review clinical study plans, reports, and study metrics.
Participate in study feasibility assessments and selection of
countries and sites for study conduct.
Participate in creation and conduct of study-specific training
at investigator meetings.
All work must adhere to ICH Good Clinical Practice (GCP)
guidelines and comply with Pliant SOPs.