临床监查员/CRA

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.

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.

任职要求：药物相关监查经验1年以上，英语读写熟练，口语可以简单沟通，扎实的GCP知识和监查技能，良好的沟通与协调能力。

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