Job details
Position summary:
The Clinical Research Assistant supports the Stryker NV China Clinical Affairs team in the execution of clinical study management, operational activities as well as medical writing projects.
The Clinical Research Assistant executes all administrative aspects of study management from start-up through closeout under the guidance and mentorship of senior clinical staff.
Ensures strict adherence to applicable regulations, ICH/GCP/GDP guidelines, and Stryker NV SOPs.
Executes strategic and operational directives from the Clinical Affairs and Medical Writing Manager with a focus on timeliness, accuracy and compliance.
Essential Duties & Responsibilities: (Detailed Description)
Under direction of clinical management, performs activities for ongoing clinical trials (local or global) and clinical operations including status report generation, payment processing, device maintenance, regulatory document tracking, Case Report Form (CRF) files, required regulatory documentation, etc.
Assists with archiving study documents into eTMF and sponsor master binders.
Assists with distribution, collection and tracking of regulatory documents (e.g., confidentiality agreements, financial disclosures, IRB approvals, investigator agreements, site contracts, study/project annual reports) to/from study sites.
Assists with document stamping for clinical studies, medical writing and clinical operations.
Assists with document release via PLM system for clinical studies, medical writing and clinical operations.
Supports the coordination of Investigator Meetings, including managing vendor quotations and selection, facilitating bid-defense presentations, and handling all scheduling logistics.
Assists with preparation of Clinical Events Committee packets for CEC adjudication meetings.
Assists with maintaining file folders, documents and trackers for NV China Clinical Affairs department and related projects/initiatives.
Assists with vendor selection and management activities by partnering with CRAs, Project Managers
Assists with contracts/payments activities by working with finance and accounting.
Assists with process improvements to increase team efficiency and effectiveness.
Assists with the tracking of study team trainings per project training plan
Demonstrates working knowledge of clinical research conduct, laws, regulations, and complies with applicable Stryker SOPs and policies.
Distributes, collects, and tracks project specific documentation accurately and within project timelines.
Ensures Master User List (MUL) for database access and other role specific applications is complete and up to date.
Maintains site contact lists, GCP office lists, IRB contact lists and assists in mass mailings.
Establishes and maintains the Clinical Trial Management System (CTMS) and Trial Master File (TMF) in inspection-ready state.
Communicates with assigned sites to drive collection and review of essential documents throughout the study, performs QC reviews of study files, and follows up on issue resolution.
Supports development and maintenance of study documents and templates, reviews activities of assigned clinical trials to ensure data integrity and adherence to NMPA regulations, company policies, and any other applicable procedures.
Assists with clinical site audits and sponsor process audits.
Assists with the preparation and dissemination of Department newsletters, Project newsletters by collaborating with Project Managers, Medical Writers, and Line Manager
Assists with device-handling processes, tracking inventory at sites and support device reconciliation.
Performs other duties and operational tasks as assigned by the Line Manager.
Education & Experience:
Bachelor's level degree or licensed certified health care training or equivalent combination of education and experience.
At least 1 year of relevant experience in Clinical Research industry.
Fundamental knowledge and good understanding of GCPs, clinical study development process, and logistics required.
Biotech, Healthcare or Pharma background.
Team based work experience required.
Regulatory Affairs experience is a plus.
Project Management certification is a plus.
Other Requirements:
Working proficiency in verbal and written English (capable of conducting meetings, drafting summaries, and correspondence).
Willingness and flexibility to travel as required.
Strong working knowledge of Microsoft Office Suite (Word, Excel, PowerPoint).
Strong aptitude for learning clinical research fundamentals and regulatory guidelines.
High attention to detail and commitment to compliance.
Ability to prioritize multiple tasks in a fast-paced environment.
