DOCS Clinical Research Associate in Shanghai, China
Clinical Research Associate
Ref #: 22511
Employment type: Permanent - Full-Time
Do you have clinical trial monitoring experience of phase II-III Oncology studies?
Do you love monitoring and being an active part within drug development?
Then look further, this is the role for you!
Our client is looking to recruit an experienced CRA who can demonstrate strong Oncology clinical trial monitoring of phase II-III studies within the industry.
What is Offered
Permanent career opportunity
Office based in City / Homebased
The Role and your Responsibilities
To perform all aspects of CRA duties from site selection, site initiation, through to site routine monitoring visits through to close-out visits and database lock.
Contributes to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.);
Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study related documentation, organisation of meetings and other tasks as instructed by the PM;
Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department;
Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports;
Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports;
Communicates effectively with site personnel, including the Principal Investigator (PI), and company management to relay protocol/study deviations and ensure timely implementation of corrective actions;
What is Required
Degree (BA/BS/BSc) in life sciences or qualified nurse
At least 12/18 months CRA experience gained within the industry as a Clinical Research Associate (CRA) either in Clinical Research Organisation (CRO) or pharmaceutical industry or investigational site
Experience of Oncology external/independent clinical monitoring of phase II-III clinical trials preferred (other therapeutic areas could be considered)
Experience of clinical trial set up and contract negotiation preferred, but not essential
Experience in Oncology is preferred
EDC working experience
DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.