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Reporting to the Director of Clinical Operations, this person will be responsible for overall site management, including but not limited to on site monitoring (source verification), query resolution, maintenance of site essential documents and reporting status to the clinical team. Work will be performed in accordance with the protocol, standard operating procedures (SOP), and good clinical practices (GCP) as defined in the regulations and guidelines under the International Conference on Harmonisation (ICH) and the U.S. Food and Drug Administration (FDA).  Work is performed in a collaborative team environment under minimal supervision and guidance.  Travel is required.


General Information

Status:  Part or full-time, temporary to permanent is possible.


Position Summary / Primary Responsibilities (essential functions)

 Serve as a liaison for a project or study and disseminates information to the project team, investigators, study coordinators, and physicians.

 Assist in collection of essential regulatory documents from study sites during site initiation and throughout the study.

 Participate in training of site personnel.

 Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events.

 Report monitoring activities and study site conduct accurately and completely.

 Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner.

 Coordinate activities with project team members and study sites to ensure compliance with the protocol and overall clinical objectives.

 Prepare required study documentation and assist with the creation of presentations of clinical research study information.

 Assist with monitoring drug supply to ensure compliance throughout trial.

 Monitor the execution of the clinical study against the specified timelines, deliverables, budget, and expense analysis.

 Provide assistance in auditing central files, and with collecting/tracking and summarizing patient information.

 Participate in the development, maintenance and distribution of Clinical Standard Operating Procedures (SOPs), Case Report Forms (CRFs) and other documents.

 Participate in development and execution of patient recruitment efforts.


Qualifications / Requirements

 Requires a Bachelors degree, preferably in a health related discipline.

 Minimum 2 years relevant clinical research experience for a CRA.

 Experience in Urology or Oncology desired.

 Knowledge of GCP guidelines and regulations as defined by ICH and FDA, and is highly familiar with industry best practices.

 Discretion in handling confidential information.

 Knowledge of project management tools and practices, and proficient in using normal office software; Microsoft Word, Excel and PowerPoint.

 Excellent verbal and written skills, good organizational, interpersonal, and team skills.


Compensation

 Commensurate with experience


Job Location:  Auburndale, MA

Please apply to careers@advantagene.com.  Please send resume and a cover letter and please reference “CRA” in your application.

No recruiters please.




Clinical Research Associate