Company: Worldwide Clinical Trials
Location: Home Based - Australia
Closing Date: 03 Nov 16
Salary (£): Competitive
Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
This is a career enhancing opportunity for a Clinical Research Associate II or SCRA to join an global Contract Research Organization and take their career to the next level.
Home based - anywhere in Australia
Cardiovascular experience highly desirable
Tasks may include but are not limited to:
•Perform feasibility studies for potential sites as requested
•Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements
•Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)
•Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site
•Document site visit findings via written reports
•Assess, monitor, and train study site staff on protocol adherence as required
•Review study subject safety information and informed consent
•Conduct source document verification for compliance, patient safety, and veracity of data
•Review CRFs using paper or electronic data capture systems
•Assist the site in maintenance of the Investigator Site File
•Maintain regular communication with sites
•Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)
•Assist sites in data query resolution
•Ensure site compliance with IP receipt, accountability and return or destruction
•Complete final site close out visit and report
OTHER SKILLS AND ABILITIES:
•Good oral and written communication skills
•Good planning and organizational skills with effective time management
•Good interpersonal skills
•Ability to work in an organized and methodical manner
•Advanced understanding of clinical research principles and process
•Extensive understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirements
•Good understanding of standard operating procedures
•Good knowledge of Microsoft Office
•Familiarity with IxRS, EDC systems
•Medical Doctor (MD) degree OR
•A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR
•At least 2 years experience as a CRA
•Willingness to travel required
•Valid current passport required
•Driving license required
•Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English
Worldwide Clinical Trials,does not accept unsolicited resumes from third-party recruiters or agencies. Any third-party resumes forwarded by recruiters to WCT or to any of our employees will be considered public information, may be treated as a direct application from the person identified in the resume, and will not be eligible for placement fee payment to the agency.
Due to the volume of applications, we regret that we can only respond to successful candidates.
Worldwide Clinical Trials
2nd Floor 172 Tottenham Court Road London
|Tel:||0207 121 61 61|
|Website:||Visit Our Web Site|
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