In-House Senior Clinical Research Associate

Job Description
Mar 8, 2012

As the ProFibrix In-House CRA, you will be managing the activities of CRAs from an external CRO that will conduct all aspects of an international phase III clinical trial. You will work with the CRO and clinical sites to ensure subject safety, data integrity, and adherence to the study protocol and various regulations.

You will ensure the CRO staff and clinical sites have all information, documentation and supplies available in order to conduct the trial:

Participate in on-site qualification, initiation, monitoring and close-out visits as co-monitor

Available to travel 30%

Attend site surgical procedures for site training and support

Act as a resource to CRO CRAs for operational consistency

Provide oversight for preparation of document submissions to IRB/IECs

Review site IRB documents for IMP release

Review monitoring visit reports and provide follow-up as necessary

Review Informed Consents, Protocols, study manuals, templates and other study related documents

Function as a primary contact for CRO Clinical Trial Managers and CRAs

Ensure CRO performance per contract terms, GCP/ICH adherence and overall quality of work

Perform in-house eCRF data review and reconciliation

Monitor site drug supply needs on an ongoing basis

At study conclusion, reconcile overall drug accountability and trial master file organization and content

Ensure adequate CRO CRA training and compliance

Assist with reviewing and writing relevant SOPs, guidelines, templates and policies

Act as an ambassador representing ProFibrix to the medical and research communities
You will be responsible for overall study documentation and are expected to play an active role in the clinical team meetings:

Facilitate the flow of information among CRO, CRAs and ProFibrix team members

Participate in teleconferences across multiple time zones

Participate in study team meetings

Participate in Investigators' Meeting

Manage and maintain in-house clinical files

Maintain project tracking systems of subjects, supplies and site information

Manage study supply tracking

Assist clinical project team with assessing project feasibility and recruitment, provide clinical updates as applicable


Bachelors in scientific discipline, RN, health care professional or equivalent

Strong knowledge of clinical research processes, ICH-GCP, federal regulations and applicable local laws pertaining to clinical research investigation

Minimum of 4 years clinical research monitoring experience in the pharmaceutical/biotechnology industry

Experience with project, vendor and contract management

Basic knowledge of medical terminology

Proficient computer skills including Microsoft Word, Excel and Outlook

Familiar with various eCRF data collection system


ProFibrix, Inc.

Job Code

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