Senior Clinical Research Associate

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

Negotiate site budgets and assists with the execution of site contracts with support from the legal department and PM

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

Oversee all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good quality assurance reports

Establish update, track and maintains study specific trial management tools/systems, and status reports

Perform pre study visits: discusses protocol, other available study documentation and study requirements with Investigator and other trial staff, ensures that trial staff and site facilities and the site’s recruitment potential are in accordance with protocol requirements, local regulations, ICH-GCP and GC CRO’s SOPs

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

Perform site monitoring visits: ensures adherence to protocol, accurate data collection via

source document verification per the monitoring plan, and investigational product/biological samples/supplies accountability

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

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

Maintain study tracking, in accordance with the demands of the study

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

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

Perform data management review, including in-house CRF review, and alert PMs and data managers to emerging issues with CRF completion

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

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

Liaise with data management to resolve data discrepancies and ensure all data management study goals are met;

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

Prepare accurate and timely visit reports from all types of visits

May be involved in preparation of status reports for clients

May review protocols, consent forms, eCRFs, study manuals and other study documents, as requested by the PM/management/study team

Conduct feasibility work

Interact with internal work groups to evaluate needs, resources and timelines

Initiate payment requests for Investigators

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

At least five years’ experience in monitoring clinical trials in CRO (preferable), Pharmaceutical and/or Biotechnology industry as a SCRA/CRA/Monitor.

Experience in EDC & CTMS

Experience in all aspects of site-management from site selection to site close-out

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

Excellent communication skills, written and oral and good presentation skills

Excellent organisation and time management skills

Proactivity and risk management skills

Excellent computer skillsUndertake travel, domestically and internationally to fulfil the requirements of the role

Own your development, learn everyday

The opportunity to work for one of the most influential leaders

Work/life balance with opportunities to work from home on occasion