北京招聘

PURPOSE
Conduct monitoring visits for assigned protocols and study sites. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.

RESPONSIBILITIES
？ Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
？ Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
？ Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
？ Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager.
？ Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
？ Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
？ May provide assistance to less experienced clinical staff.
All responsibilities are essential to job functions unless noted as non-essential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
？ Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
？ Strong therapeutic and protocol knowledge as provided in company training
？ Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
？ Strong written and verbal communication skills including good command of English language
？ Strong organizational and problem-solving skills
？ Effective time management skills
？ Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
？ Bachelor's degree in a health care or other scientific discipline or educational equivalent and 1 year of on-site monitoring experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS
？ Extensive use of telephone and face-to-face communication requiring accurate perception of speech
？ Extensive use of keyboard requiring repetitive motion of fingers
？ Regular sitting for extended periods of time
？ Frequent travel to sites, primarily domestic, may include international travel

ABOUT THE COMPANY
Quintiles Transnational Corp. strives unceasingly to exercise strong LEADERSHIP in our industry and to be the unquestioned FIRST CHOICE Contract Pharmaceutical Organization in an increasingly competitive marketplace.
We will DELIGHT our CUSTOMERS world-wide with the fullest range and highest quality of information and services, and with a spirit and a DEDICATION that bring professional esteem and admiration.
We demand the utmost level of EXCELLENCE, CREATIVITY, and SKILL from all our staff and management so that we add value to our customers by driving to PERFORMANCE goals in ways that are quantifiable.
We thrive on continuous IMPROVEMENT and QUALITY enhancements through attention to detail,consistent feedback, state-of-the-art systems, TRAINING and TEAMWORK.
We seek unendingly to bring our customers'PRODUCTS and SERVICES to MARKET ever sooner and to play a creative role in their achievement of earlier and greater commercial SUCCESS.
Throughout our commercial pursuits, we will respect and hold in esteemed honor our EMPLOYEES, to whom we owe our very existence.
We will maintain and enhance our reputation and integrity by demanding the highest possible ETHICAL STANDARDS and demonstrate by example an unyielding dedication to employees, customers, vendors, and shareholders. A SHARED VISION of success among these stakeholders will enhance the quality of life for all people of the world as we vigorously pursue our mission in an era of unprecedented OPPORTUNITY