Contract In-House Sr. CRA/Oncology

Our Client, a large pharmaceutical company in northern, NJ is looking for a Contract Sr. CRA for a six month contract opportunity. This is an In-House opportunity on an Oncology study that will require up to 40% travel.

Position Overview:

As member of therapeutically aligned Clinical Study Management team, the Clinical Research Associate will be responsible for supporting the Clinical Project Manager with the planning, implementation, monitoring and management of clinical studies.





Major Position Activities & Responsibilities:

Work with Clinical Project Manager to organize and facilitate the overall activities required to plan, coordinate, track and manage the general performance of clinical trials.

Responsibilities may include, but are not limited to, the following:

In-house and field site monitoring of clinical trial investigational sites to ensure study protocol compliance in adherence to GCP/ICH guidelines.

Communicating with sites to ensure study procedures are followed, to collect essential trial information, to address and resolve study-related issues.

Maintaining accurate study data to track enrollment, study supplies and milestone payments.

Conducting pre-study, site initiation, interim monitoring and site close-out visits with resulting visit reports.

Ensuring study data and drug accountability records are accurate and verifiable.

Collecting, maintaining and managing study documents and files within Trial Master File.

Maintaining study-related information within Clinical Trial Management System.

Supporting Clinical Project Manager with developing study-specific documents and operational procedures related to all phases of conducting clinical studies from start-up to close-out.

Assisting Clinical Project Manager with compiling study data for reporting to cross-functional teams and senior management.





Background Qualifications:

Bachelor degree required preferably in the life sciences

A minimum of five years clinical research experience with a minimum of 3-4 year's direct monitoring experience.

Demonstrated knowledge of the clinical development process/GCPs/ICH guidelines.
Knowledge in the following therapeutic areas: Oncology, Transplantation or Immunology.

Computer literacy in, MS Word, MS Project and Excel.
Effective communication (verbal and written) and organizational skills.
Excellent interpersonal skills.
Must be willing to travel up to 40% domestically, as required.





Organization Chart:

The Clinical Research Associate reports to a Project Manager in Clinical Operations.