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PPD

Clinical Research Associate - CRA I/II, Sr CRA I/II, Principal CRA - Shanghai, Home based

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. In 2018 alone, the Clinical Management team is expected to triple in size. 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 forClinical Research Associates (CRA I/II,Sr CRA I/II, Principal CRA) to join our Clinical Monitoring department. From our office in Beijing to Shanghai, this department defines and develops clinical programs in China. We ensure the highest-quality review of data and effective interaction with study sites, including on-site monitoring throughout a study. Our clinical research associates (CRAs), remote site monitors (RSMs), project assistants (PAs), and client-dedicated teams oversee and administer the health and efficacy of treatments during trials. We support the logistics and organization of clinical sites-ensuring that patients receive needed care, as well as identifying and treating clinical trial participants.

Essential Functions and Other Job Information:
  • Monitors investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification). Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously, present potential solutions and follow all issues through to resolution. Maintains regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan.
  • Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
  • Manages the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial.
  • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
  • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
  • Responds to company, client and federal regulatory requirements/audits.
  • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
  • Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
  • Other project work as assigned.


Job Qualification:

Education and Experience:
  • Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (1+ years as a clinical research monitor) or completion of PPD Drug Development Fellowship or equivalent combination of education, training, & experience.
  • Valid driver's license where applicable

Knowledge, Skills and Abilities:
  • Proven clinical monitoring skills
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
  • Demonstrated ability to attain and maintain a working knowledge of GCPs and applicable SOPs
  • Good oral and written communication skills, with the ability to communicate effectively with medical personnel
  • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
  • Good organizational and time management skills
  • Effective interpersonal skills
  • Attention to detail
  • Ability to remain flexible and adaptable in a wide range of scenarios
  • Ability to work in a team or independently as required
  • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
  • Good English language and grammar skills
  • Good presentation skills

Our offer: As a compensation, you will be provided with a competitive remuneration, corporate trainings and the opportunity to become a part of a fast growing, multinational company. At PPD, we encourage our employees to demonstrate creativity, innovation and fresh insights as well as a solution-focused approach. We also value teamwork, camaraderie and enthusiasm. This is a full-time, permanent position.

Locations we are hiring in are:
  • Office based Beijing
  • Office based Shanghai
  • Home based other locations China


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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