Clinical Research Associate

Act as a member of the project team with the goal to contribute towards efficient managementof trials;

Negotiate site budgets and assists with the execution of site contracts with support

Support recruitment of potential Investigators, preparation of Human Research Ethics Committee (HREC)submissions, notifications to regulatory authorities,translation of study related documentation, organisation of meetings and other tasks asinstructed by the PM;

Oversee all aspects of study site management to ensure high quality data resulting in

Establish, updates, tracks and maintains study specific trial management tools/systems, andstatus reports;

Perform pre study visits: discusses protocol, other available study documentation and studyrequirements with Investigator and other trial staff, ensures that trial staff and site facilities andthe site’s recruitment potential are in accordance with protocol requirements, local regulations,ICH-GCP and GCCRO’sSOPs;

Perform site initiation visits: trains Investigators and other trial staff in the protocol and datacollection methods to ensure collection of patient data is accurate, complete, and conforms toprotocol requirements, in accordance with local regulations, ICH-GCP and GC CRO’s SOPs;

Perform site monitoring visits: ensures adherence to protocol, accurate data collection viasource document verification per the monitoring plan, and investigational product/biologicalsamples/supplies accountability;

Communicate effectively with site personnel, including the Principal Investigator (PI), andGC management to relay protocol/study deviations and ensure timely implementation ofcorrective actions;

Develop and maintain strong working relationship with Investigators and study staff, serving asan ambassador to promote GC’s high quality and ethical image;

Maintainstudy tracking, in accordance with the demands of the study;

Understand and updates Clinical Trial Management System (CTMS) in a timely manner;

Monitor and update data in an Electronic Data Capture (EDC) system in a timely manner andin accordance with study specific guidelines;

Perform data management review, including in-house CRF review, and alert PMs

Identify and process Serious Adverse Events (SAEs) according to the procedures defined bythe study team;

Demonstrate a broad understanding of the SAE reporting process to regulatory authorities;

Liaisewith data management to resolve data discrepancies and ensure all data managementstudy goals are met;

Perform data management review, including in-house CRF review, and alert PMs

and data managers to emerging issues with CRF completion;

Prepare and perform site closeout visits according to the protocol, local laws, ICH-GCP andGC CRO’s SOPs;

Prepare accurate and timely visit reports from all types of visits;

May be involved in preparation of status reports for clients;

Conductfeasibility work;

Interactwith internal work groups to evaluate needs, resources and timelines;

Initiate payment requests for Investigators;

Perform other duties as assigned by management;

Travelas necessary according to project needs.

Your key working relationships:

As the CRA, you need to develop strong relationships with the following internal parties:

Clients and potential clients

Other CRO members

Site Management Organisation (SMO)/siteresearch teams

Clinicians and KOLs

Shared Services

Experience:

Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals)

At leastthree years’ experience in monitoring clinical trials in CRO (preferable), Pharmaceutical and/or Biotechnology industryas a CRA/Monitor.

Experience in EDC & CTMS

Experience in site selection

Experience in contracts negotiation desirable 

Experience in HREC submission preparation

Understanding and practical knowledge of ICH-GCP requirements particularly as required for site management.

Experience working in Oncology and Cardiology therapeutic areas highly preferable 

Able to work in an international environment with internal & external team partners (including virtual teams) and Asia Pacific/European experience is highly desirable 

Other requirements for this role:

Excellent communication skills, written and oral and good presentation skills

Excellent organisation and time management skills

Proactivity and risk management skills

Excellent computer skills

Undertake travel, domestically and internationally to fulfil the requirements of the role