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Job ID: 3873
Title: CRA - West Coast
Location: AB
Title: 2-CRA: Regional
Industry:
Post Date: 08/20/2014

Job Description:



CLINICAL RESEARCH ASSOCIATE
 

Position Overview:

 


This position reports to:

CRA Manager (CRAm), Rest Of the World (ROW)

This position supervises:

None

Key relationships are maintained with: 

Monitoring Resources Coordinator (MRc) ROW, Project Management


 

Job Key Duties and Responsibilities:

 

This position is responsible for performing any/all of the following tasks and responsibilities, as well as any other tasks deemed appropriate by the Supervisor:

 

        Monitor activities at assigned clinical study sites to assure adherence to ICH GCPs, local regulatory requirements,  Standard Operating Procedures (SOPs), Standard Guidelines (SGs), Instruction Manuals (IMs), study protocols and study-specific SGs/IMs, for multiple projects

        Conduct Pre-Study Site Visits (or calls), Study Initiation Visits, Routine Monitoring Visits and Site Close-out at assigned clinical study sites as per  SOPs/SGs/IMs and study-specific SGs/IMs

        Perform source document verification, validate Case Report Forms (CRFs) and perform queries resolution in a timely manner to ensure clean data availability for studies analyses

        Ensure Serious Adverse Event (SAE) reporting according to project specifications

        Input and maintain study information in tracking systems: Provide regular/accurate sites status updates and common site trends to Monitoring Resources and Project Management Departments

        Oversee study drug management at clinical study sites (availability, receipt, handling, storage, dispensation, tracking and accountability, and destruction/return)

        Perform Investigator Study File reconciliation: request any new or updated site-related essential documents and review them for content, consistency with other documents, and compliance with local regulatory requirements, ICH-GCPs guidelines, SOPs

        Respond to requests from clinical study sites in a timely fashion

        Establish and maintain good rapport with clinical study sites

        Assist during on-site audits (if required) and preparation of site audit report reply. Assist with the implementation of corrective actions/preventive actions, when appropriate

        Adhere to corporate internal polices and requirements, including submission of training documentation, visits planning, timesheets and expense reports in a timely manner

        May, upon request from MR management team, mentor new CRAs and Junior CRAs (including evaluation of strengths and development areas of mentored persons) on-site and serve as a resource for new CRAs

        May, upon request from MR management team, participate in some SOPs/SGs creation/revision working groups, work with MR management on monitoring strategy

 

 

Education and Training:

 

        Bachelor's Degree in allied health fields such as Medical, Nursing, Pharmacy, or Health Science or its international equivalent

 

Experience and Key Competencies:

 

        At least 2 years experience as CRA in the field; or very strong experience as Research Nurse or Study Coordinator in oncology

        Oncology and local regulatory requirements knowledge would be a major asset

        Strong ICH-GCPs knowledge

        Ability to travel up to 60% on average

        Ability to prioritize multiple tasks and achieve project timelines

        Effective time management in order to meet daily metrics or team objectives

        Must work both independently and in a team environment

        Excellent interpersonal, verbal and written communication skills and attention to details

        Ability to work in a multi-cultural environment

        Read, write and speak fluent English; fluent in monitoring country language (if different from English)

        Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail

        Ability to manage sites independently

 

 

Job Requirements:
SOLID TUMOR, 3 years MIN monitoring experience. Stong Oncology experience
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