Giám sát Nghiên cứu Lâm sàng/ Clinical Research Associate 2

Tòa nhà Capital, 109 Trần Hưng Đạo

Nơi làm việc: Hà Nội

Số lượng: 1 Hết hạn: 03-08-2018

Hết hạn

3149 lượt xem Đăng tuyển 2395 ngày trước

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RESPONSIBILITIES

Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
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 as appropriate.
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. May support start-up phase.
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.
Build awareness of features and opportunities of study to site.
Collaborate and liaise with study team members for project execution support as appropriate.

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 trainingComputer 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 languageStrong organizational and problem-solving skills
Effective time management skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Bachelor's degree in a health care or other scientific discipline or educational equivalent and 2 year of on-site monitoring experience; or equivalent combination of education, training and experience