长沙招聘

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 Team Lead (CTL) 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 and other required study documentation.
？ May provide assistance to more less experienced clinical staff.
？ All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
？ Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
？ In depth 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 lap top computer
？ Strong written and verbal communication skills including good command of English language
？ Excellent organizational and problem-solving skills
？ Effective time management skills
？ Ability to manage competing priorities
？ 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 more than 1 year of on-site monitoring experience; or equivalent combination of education, training and experience
？ Demonstrate a sound knowledge of all relevant systems and regulations, including GCP
？ Demonstrate a sound knowledge of internal CBOPs, CPs, Corporate Quality Manual, WSOPs and Operational Guidelines
？ Ability to negotiate with respect and influence to achieve results
？ Strategic thinking
？ Excellent problem solving, risk assessment and decision making skills
？ Willing and able to travel as required – local or international.
？ Good English written and oral communication skills.
？ Significant work experience in clinical research, including a working knowledge of data management/technical background desirable.

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