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PPD

Study Start-Up, Clinical Research Associate (CRA)

PPD is proud to employ over 20,000 employees worldwide, across 47 countries and 89 offices. In just over 30 years, PPD has grown to become a leading U.S. based CRO and recently has won accolades for industry leading CRA team, employee training & development, excellence in service and numerous awards for Best CRO. Our sustained year on year growth means that we are always looking for exceptional clinical talent to join our company.

Since opening in 2007, PPD's offices in China now include 20 different departments. The combined Beijing and Shanghai offices are now seven times the size they were two years ago and are continuing to grow. PPD China is able to offer our staff opportunities to collaborate on projects not only in Asia Pacific, but in regions around the world. You'll have the opportunity to work on multinational trials-with top-tier sponsors, and on an industry-leading platform.

This is a great time to join PPD China. Currently PPD is recruiting for SIA - Clinical Research Associate to join our Site Intelligence & Activation (SIA) department. Our goal-driven teams combine and deliver study start-up activities for clinical trials in China, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease start-up timelines and exceed expectations.

Essential Functions and Other Job Information:
  • Provides Site Selection support for awarded multi-service projects
  • Conducting the Site Selection assessments locally via communication with investigators. Conduct of country- and site-level feasibility.
  • Conduct pre-study visits (PSVs), prepare PSV-reports, and provide information leading to a decision to render the site qualified or not qualified for participation in the trial.
  • Key-contact at country level for either Ethical or Regulatory submission-related activities. Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
  • Achieves PPD's target cycle times for site
  • Develop and implement the local submission strategy and provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments to ensure all site start-up activities are aligned with submission activities and mutually agreed upon timelines.
  • Prepare, review and coordinate the local regulatory submissions (MoH, EC, additional special national local applications if applicable, import licenses etc) in alignment with the global submission strategy.
  • Develop country and site specific Patient Information Sheet/Informed Consent form and other patient related documents as applicable.
  • Ensure the submission process for sites and studies are aligned to the critical path for site activation.
  • Developed collaborative relationships with investigative sites and client company personnel.
  • Provide, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients,
  • Collection of CDA/DPA/IBI from the site, distribution of electronic (in some cases paper) feasibility to sites, CTMS entry and tracking of all Site Interest Plan documentation and associated communications; facilitation of information to the GIS representative for site creation in CTMS.
  • Negotiate and finalize site contracts and budgets as necessary
  • Maintain regular site contact during the start-up phase and document all communications in CTMS.
  • Collect and QC's all trial commencement documents including essential (RCR) and non- essential (non RCR) documents and certifications.


Job Qualification:

Education and Experience:

Bachelor's degree or above

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years') or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities:
  • Effective oral and written communication skills
  • Excellent interpersonal skills
  • Strong attention to detail and quality of documentation
  • Good negotiation skills
  • Good computer skills and the ability to learn appropriate software
  • Good English language and grammar skills
  • Basic medical/therapeutic area and medical terminology knowledge
  • Ability to work in a team environment or independently, under direction
  • as required
  • Basic organizational and planning skills
  • Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations


Diversity Statement

PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

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