长沙招聘

Description

Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.

If that is your passion, we have a place for you.

Regulatory and Start-Up Specialist 1

RESPONSIBILITIES

？ Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.

？ Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.

Distribute completed documents to sites and internal project team members. ？

Prepare site regulatory documents, reviewing for completeness and accuracy. ？

Review, prepare and negotiate site contracts and budgets with sites, if applicable. ？

Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. ？

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

Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed. ？

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

Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics, ICF and IP Release documents, in line with project timelines. ？

Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning. ？

Perform quality control of documents provided by sites. ？

May have direct contact with sponsors on specific initiatives. ？

May perform Site Selection Visits if a trained monitor. ？

May participate in feasibility and/or site identification activities.

Qualifications
Requirements:

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

Effective communication, organizational, planning and interpersonal skills. ？

Ability to work independently and to effectively prioritize tasks. ？

Ability to work on multiple projects. ？

Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines. ？

Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards. ？

Understanding of regulated clinical trial environment and knowledge of drug development process. ？

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

QuintilesIMS pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.
 
If that is your passion, we have a place for you.