Clinical Science Specialist

Job type:
on-site
Start:
08/2013
Duration:
6 month minimum
From:
Real Staffing
Place:
South San Francisco
Date:
08/16/2013
Country:
flag_no USA
project ID:
584042

Warning
This project is archived and not active any more.
You will find vacant projects in our project database.
Responsibilities:

Support Clinical Science deliverables for clinical trials and programs associated with the exploratory clinical development of novel anti-cancer agents. These programs span first-in-human Phase I studies through proof-of-concept Phase II studies in a variety of malignant disorders, and may involve collaborations with other Clinical Development teams, corporate development partners, and external scientific/academic/clinical organizations.

Multiple years of industry experience is required, IND filing is a plus; Develops study-specific listings with data management representatives and conduct frequent clinical data listing reviews.

Working closely with the medical monitor, serve as primary point of contact for, and triage, clinical study inquiries from site staff, CROs and site monitors regarding the study protocol, modifications to informed consent, and patient-specific questions.

Partner with Data Management for CRF design, instructions for unique CRFs, and data quality plan.

Participate in tracking/analysis of any potential safety events within a given trial and across trials for assigned program(s).

In conjunction with Biostats and Medical Director review appropriate analysis and reporting documents (i.e. clinical study report (CSR), analysis plan, etc.) and writing manuscripts.

Education: MD or equivalent

To find out more about Real please visit www.realstaffing.com