Snr. Clinical Research Associate

Summary about this job

Detail information about job Snr. Clinical Research Associate. Terms and conditions vacancy

For our successful CRO clients we are looking for a number of experienced (3 years +) self-motivated and managed CRAs. The work location is in the Australia's major cities, travel required. Home based.

To be successfully selected you contribute:

• Excellent Communication skill

• Be the communication hub between the CRO company and the site teams, as the first point of contact for the sites study team, i.e. investigators and study coordinators and pharmacists etc.

• Good ICH GCP knowledge and Therapeutical skills

• Good command re clinical trial activities, i.e. from Start up to Conduct until Close-out

• Outcome and result oriented, to achieve study milestones on time and within study budget

• Commitment to study compliance: ICH GCP, local regulations and SOP

• Focus on protocol compliance, patient safety and data quality

• Good knowledge of Pharmacovigilance and safety reporting

• Team spirit and experience

• Highly motivated, self-learner

Responsibilities:

• Facilitate communication between sites and the CRO study teams

• Participate in study start up activities including site feasibility, site selection, EC submission etc.

• Prepare and execute site initiation and training

• Work with selected sites to complete monitoring visits (on-site or remotely)

• Facilitate preparation and collection of site level documents; be the first point to resolve issues as required.

• Operational tracking of trial execution milestones; including identify and measure progress; resolve issues and escalate when required.

• Manage resource levels and prepare and contingency plans, as needed

• Complete preparation/generation of study monitoring reports.

• Manage data at the site; resolve technical and content issues to achieve competitive database lock targets

• Implement site closeout activities

• Act as local lead, if required

• Act as a mentor to new associates for purposes of field

• training, as assigned

• Participate in multi­disciplinary teams to evaluate and

• Implement process improvement

Key Requirements:

• Bachelor's Degree in relevant science field or nursing credential

• A minimum of 3 years' clinical monitoring experience in Australia &/or New Zealand

• Extensive knowledge of ICH GCP Guidelines and other applicable regulatory requirements

• Demonstrated proficiency in problem solving, managing multiple priorities and a commitment to quality and customer focus

• Proven ability to work independently in an efficient environment

• Strong communication, interpersonal and organizational skills

• Must have a full Australian Driving Licence

• Must have full working rights to work in Australia

Our client's offer:

• Competitive remuneration package with benefits that reflect the candidate's contribution.

• Inclusion into the clients offered development and training, with the opportunity to excel your career within our client's a market leading and innovative international organisation

• Your chance to work within a stimulating and rewarding environment.

• Mandarin language skills is not essential and would be a bonus.

If you are interested in this exciting CRA opportunity, please send your resume to [email protected]