Get Our FREE Industry eNewsletter

Clinical Research Associate (In-House)

Ophthotech

Apply
Location:
Princeton, NJ
Posted Date:
7/2/2014
Position Type:
Full time
Job Code:
201007 or 201002
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Research, Clinical Trial,

Job Description

•   Accountable for the setup, quality and maintenance of the electronic Trial Master
Files (TMF) in accordance with Company SOPs. Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with Company SOPs, GCP and ICH Guidelines.
•   Support clinical study manager(s) with day-to-day operations of Company clinical trials, including activities such as:
•   Act as liaison for assigned study sites to convey project information
•   Arrange for certified translation of study documentation as appropriate
•   Assist the project team in preparation for audits/inspections, taking responsibility for the quality and completeness of in-house documentation.
•   Collaborate with CRA(s) to obtain/share trial specifics issues across all study sites, concentrating on areas related to quality, site performance and metrics
•   Ensure that all regulatory documents and study supplies are maintained during the lifecycle of any assigned project in collaboration with the assigned CRA
•   Review various study related tracking systems to determine and report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, IB etc.) and follow up to collect outstanding documents
•   Provide quality overview and consistency check on all developed ICFs and complete the informed consent checklist
•   Coordinate and secure IRB approval (local and central)

Requirements

•   Bachelors' degree required (science-related discipline strongly preferred)
•   A minimum of 3 years of clinical trial experience within pharmaceutical,  biotechnology, CRO and/or healthcare setting
•   Demonstrated computer skills (MS Office, MS Project, PowerPoint)
•   Demonstrated core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan
•   Direct expertise of site management and logistical execution of clinical trials for at least 2 years
•   Knowledge of GCP as relates to clinical trial management
•   Previous on-site monitoring experience

By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.