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Clinical Research Administrator in Plainsboro Township, NJ at Integrated Resources, Inc

Date Posted: 3/20/2019

Job Snapshot

Job Description

Job Description To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.



Maintains and coordinates the administrative aspects of lntegra's Clinical Affairs dept. including clinical studies according to GCPs and S0 Ps.
Provides support for the preparation of clinical study reports, annual reports, interim updates and other study or regulatory documents, as required
Works with study teams to prepare clinical study documents, including investigator meeting materials, site and training information
Serves as a resource for clinical study sites and can triage questions/needs, as appropriate
Implements and maintains clinical filing systems for all shared documents and files and proactively identifies operational process improvements
Files and maintains study documents in the study Trial Master Files (TMFs)
Performs ongoing and final study-level and site-level TMF reconciliation
Performs data entry into designated clinical tracking systems in accordance with project requirements, including collection of information from designated clinical team members, CRO's, vendors, etc.


Assists with the processing of both vendor and site payments
Assists with gathering and tracking clinical trial accruals
Provides accurate progress reports on assigned tasks and projects
Contributes to wider organizational goals and/or activities as assigned
Ensures study compliance by understanding and applying all relevant SOPs
Performs various administrative duties such as travel arrangements, expense reporting, meeting minutes and other administrative duties for the department as needed.




INTERACTIONS/RELATIONSHIPS:


Works with department staff to support and achieve department objectives.


Works with Global Clinical Affairs members at other locations to coordinate and streamline clinical operations worldwide.

Requirements

Education: Minimum of a Bachelor degree in a relevant scientific and/or financial discipline Experience: 2 years relevant (clinical research and/or finance) experience

Specific competencies:

Strong written and verbal communication skills
Demonstrated organizational skills
Ability to work independently in a fast-paced team environment
Computer software: Microsoft Word, Excel, PowerPoint, Project, Visio
Experience using a document management system preferred
Basic knowledge and understanding of pharmaceutical regulatory requirements, including FDA and ICH guidelines would be a plus.