PPD is now part of Thermo Fisher Scientific. We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
This is a great time to join PPD China. Currently PPD is recruiting for Clinical 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.
职位要求：
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.
PPD is now part of Thermo Fisher Scientific.
Our Mission
61We enable our customers to make the world healthier, cleaner, and safer.
Our 4i Values
61Integrity - Honor commitments, communicate openly, and demonstrate the highest ethical standards
61Innovation - Create value by transforming knowledge and ideas into differentiated products and services for our customers
61Intensity - Be determined to deliver results with speed, excellence and a passion to succeed
61Involvement - Make connections to work as one global team, embracing unique perspectives and treating others with dignity and respect
If you resonate with our 4i Values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.