北京招聘

Summary:

    

Responsible for remote monitoring and site management of Phase II-IV clinical research studies while continuing to develop a solid understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations. Manages and oversees study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines, Standard Operating Procedures (SOPs) and Project Specific Operating Procedures.

    

Essential Functions:

 

1. Site Management

• Serves as the primary contact and company representative for sites on assigned studies.
• Manages assigned sites via outbound telephone calls, web-based tools and other communications tools to ensure compliance with the protocol requirements, study procedures and relevant guidelines.
• Creates contact reports for each telephone session (outbound or inbound) with sites.
• Monitors site performance metrics and, independently, implement the majority of action plans for sites not meeting expectations.
• Supports patient enrollment at each assigned site via engagement of sites in study-wide patient recruitment programs, or through development of site-specific enrolment plans.
• Maintains up-to-date information within the deployed Clinical Trial Management System (CTMS).
• Ensures all assigned sites are trained on the study protocol, informed consent process, data collection requirements/data collection tools (e.g., Electronic Data Collection (EDC) systems, Interactive Voice/Web Response (IVR/IWR) systems, etc.), Serious Adverse Event (SAE) reporting requirements and patient-reported outcomes instruments, as applicable.

 2.   Communication

• Maintains timely and effective communication among team members and site staff, through oral/written correspondence and ensures adequate documentation of each communication. Routinely anticipates, identifies, and resolves potential issues, and implements corrective actions; seeks guidance to resolve more complex and routine issues.

3.    Regulatory Documentation    

• Assures compliance with applicable regulations, and guidelines, Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs. Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Participates in TMF and audits as requested; may require guidance to respond to findings. May be responsible for submission of regulatory packages to ethics committees and/or competent authorities.

4. Monitoring

• Monitors all types of Phase II-IV clinical trials; participates in all types of remote site visits as required.

5. Data Handling

• Assures timely completion and submission of Electronic Case Reports Forms (eCRFs) in accordance with study-specific clinical and data management plans.
• Reviews eCRFs completed by sites and assists the site in resolving queries and/or other identified data collection issues.
• Assures timely and accurate completion of Data Clarification Forms.
• Performs review of clinical data listings, as required.

6.Reporting and Tracking

• Completes and submits visit reports according to SOP/Works Instructions (WI) or Sponsor requirements requiring minimal revisions.
• Maintains awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrolment, and SAEs/Endpoints.
• Updates study and patient status information. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from contact to contact.

7.Administrative    

• Prepares for and attends Investigator meetings; may present materials, as requested. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring, and/or training plans.

  

Requirements:

  

  

BA/BS degree in science/health care field or nursing degree, or equivalent combined education and experience, required. Nominal clinical research experience required including independent monitoring and site management experience preferred, whether remote or on-site. Moderate understanding of clinical research fundamentals expected. Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines, required. Strong organizational, documentation, and interpersonal skills are essential, as well as a willingness to work within a team-oriented environment. Excellent command of written and spoken local language, if not English, as well as English required. Ability to develop excellent working relationships via oral communication and excellent phone etiquette, required. Must be proficient in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Ability to handle multiple tasks to meet deadlines in a dynamic environment, required.

  

  

                    

Why Syneos HealthTM? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.