Clinical Research Associate II / Senior

Job Overview

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

Are you ready for the next step in your career? We are currently recruiting for a experienced Clinical Research Associate / Snr.

Clinical Research Associate ready to join our constantly growing CoSource team. This is a full-time, permanent and office-

based position at our Client’s office in PJ.

Site monitoring responsibility for clinical studies accordingto Covance Standard Operating Procedures, ICH Guidelines and GCP

Site management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP

Assures the implementation of project plans as assigned

Responsible for all aspects of study site monitoring including routine monitoring ond close-out of clinical sites, maintenance of study files, conduct of pre-

study ond initiation visits; liaise with vendors; and other duties, as assigned

Responsible for all aspects of site management as prescribed in the project plans

General On-Site Monitoring Responsibilities :

Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study

Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements

Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.

Monitor data for missing or implausible data

Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy

Prepare accurate and timely trip reports

Manage small projects under direction of a Project Manager / Director as assigned

Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned

Review progress of projects and initiate appropriate actions to achieve target objectives

Organize and make presentations at Investigator Meetings

Participate in the development of protocols and Case Report Forms as assigned

Participate in writing clinical trial reports as assigned

Internet with Internal work groups to evaluate needs, resources and timelines

Act as contact for clinical trial supplies and other suppliers (vendors) as assigned

Responsible for all aspects of registry management as prescribed in the project plans

Undertake feasibility work when requested

Conduct, report and follow-up on Quality Control Visits (CQC) when requested

Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-

related documentation, organization of meetings and other tasks as instructed by supervisor as assigned

Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned

Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management

Assist with training, mentoring and development of new employees, e.g. co-monitoring

Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned

Perform other duties as assigned by management

Education / Qualifications

University / college degree (life science preferred), orcertification in a related allied health profession from anappropriately accredited institution, nursing certification,medical or laboratory technology

In lieu of the above requirement, candidates with 2 or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered

Thorough knowledge of ICH Guidelines and GCP including abasic understanding of regulatory requirements in othercountries

Thorough understanding of the drug development process

Fluent in local office language and in English, both written and verbal


Minimum of 2 years of clinical research monitoringexperience (including prestudy,initiation, routine monitoring and closeout visits)

Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE

Preferably with Oncology monitoring experience

Job Number 2018-19901

Job Category Clinical Operations

Position Type Full-Time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority / Female / Individual with Disability / Veteran / Sexual Orientation / Gender Identity).

Your confidentiality and privacy are important to us.

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