北京招聘

PURPOSE

Under general supervision, perform activities associated with study site initiation process according to applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.

May participate in feasibility and/or site identification activities.

RESPONSIBILITIES

Specific responsibilities may vary across individual positions. Typical responsibilities of this job classification include the following:

·？Review and negotiate site regulatory documents and contracts with sites and sponsors for agreement on wording and budgets.

·？Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.

·？Review and provide feedback to management on site performance metrics.

·？Serve as contact for investigative sites, designated project reports, communications, and customer service.

·？Resolve site issues and determine status for product shipment.

·？Work with regulatory team members or sponsor to secure authorization of regulatory documents.

·？Work with legal team members or sponsor to secure authorization of contracts.

·？Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.

·？Inform team members of completion of regulatory and contractual documents for individual sites.

·？Work with team members in preparation of regulatory submissions per work instructions.

·？May serve as a SSU Team Lead for country or region as needed. Coordinate activities for projects within area of specialization.

·？May translate or review completed translations of critical documents.

·？May participate in feasibility and/or site identification activities.

All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

·？In-depth knowledge of clinical systems, procedures, and corporate standards

·？Strong knowledge of medical terminology and regulations

·？Broad knowledge of clinical research

·？Strong knowledge of Microsoft Office and e-mail applications

·？Effective communication, organizational, and interpersonal skills

·？Ability to work independently and to effectively prioritize tasks

·？Ability to manage multiple projects

·？Attention to detail

·？Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

·？Bachelor’s Degree in a related field and 1 year clinical research 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

微信分享