Clinical Research Associate (CRA)/Clinical Research Support Specialist CTSS in Shanghai, China

FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in Health, Education, Nutrition, Environment, Economic Development, Civil Society, Gender, Youth, Research and Technology– creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries, all 50 U.S. states and all U.S. territories. We are currently seeking qualified candidates for the position of Clinical Research Associate (CRA)/Clinical Research Support Specialist CTSS in Shanghai, China.

Position Description:

Primary function is to develop clinical site capacity to conduct clinical research at identified sites in China as part of a China Research Network (CRN). Works within assigned study site to oversee and assist the site to ensure that a study is conducted properly and meets all applicable requirements including compliance with Good Clinical Practice (GCP)

• Work with identified sites to develop a site capacity development and training plan which includes all aspects of operational implementation of a clinical trial according to ICH GCP Guidelines.
• Review study documents for completeness and accuracy, including informed consent forms, study CRF’s, site regulatory documents, study logs and other study documentation.
• Teach all aspects of the following skills to clinical sites:
  • IRB approvals, completion of regulatory approval submission processes
  • Tracking site opening progress assisting site with completing site opening tasks.
  • Drug accountability in conjunction with the FHI 360 and site pharmacist.
  • Assuring that site understands and is prepared for source data verification of CRFs
  • Review the site’s conduct of the study, identify areas where re-training is needed to ensure protocol compliance, and re-train as needed.
  • Ensure compliance of the study at the sire with the protocol, GCP, FDA and local country regulations and study-specific SOPs.
• Provide support to site staff as needed.
• Work closely with study staff, focusing on protocol compliance and site development.
• Monitor the completeness and accuracy of study staff’s work
• Review work done at sites and provide education and training to site staff as needed.
• Review compliance with site reporting requirements to FHI, the IRB/IEC and local regulatory agencies; assist with any issues identified and communicate issues to FHI.
• Prepare and track budgets and other necessary documents when required, working in conjunction with FHI staff.
• Provide assistance to other CRA/CTSSs, in-country colleagues, and others as needed.
• Attend meetings and trainings as required.
• Report site progress to study team as required.
• Represent FHI 360 at study sites and meetings as needed.
• Perform other related duties as assigned.

Contribution

• Provide weekly study updates to Research Associate
• Complete combined checklist for site development activities and study activities as needed.
• Write periodic progression reports including reports of all site visits.
• Assist site with the preparation of required documents investigator for IRB and local regulatory submissions.
• Work closely to provide side-by-side support to site staff
• Conduct visits to sites and perform duties as needed to meet duties and responsibilities.
• Provide the Research Associate and other FHI staff with immediate progress reports of any issues that affect safety of participants or the reliability of the study data.

Knowledge, Skills and Ability

• With minimal supervision, manage high volume work flow.
• Excellent written, verbal English language skills.
• Knowledge of and ability to use electronic data processing systems to gather, store, retrieve and analyze data.
• Diplomatic and culturally sensitive.
• Experience using MS Office, email, Internet Explorer
• Resourceful in resolving problems and initiating solutions.
• Bilingual Mandarin Chinese/English Preferred

Type and Nature of Contacts

Frequent interaction with site staff and FHI staff (Asia and USA-based). Others contacts with individuals outside the organization and resolve problem situations with tact.

Usual office working conditions; ability to travel (domestically and internationally) as needed up to a maximum of 24 weeks per year (may include weekends).

Minimum Requirements:

Education/Experience:

BS/BA with experience in clinical research, preferably with malaria or other infectious diseases; Bilingual Mandarin Chinese/English Preferred; TB Clinical trial experience preferred; Minimum of 1 year of on-site clinical monitoring experience.

Ability to travel up to 50%

FHI 360 has a competitive compensation package. Interested candidates may register online through FHI 360's Career Center at www.fhi360.org/careercenter or through the Employment section atwww.fhi360.org. Please submit CV/resume and cover letter including salary requirements. Please specify source in your application.