NV_Staff Clinical Research Associate_Shanghai at Stryker

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, Clinical ResearchIndustries

Requirements

Performs formal literature searches and succinctly summarizes scientific content for assigned projects
Participates in post-market surveillance activities by conducting routine systematic literature reviews (e.g., screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups
Authors integrated safety/performance data summaries and reports including China Clinical Evaluation Reports, etc., per regulation requirements
Authors the preparation of Pre-/Post-Market Clinical Study documents and other medical writing efforts including but not limited to Clinical Investigational Plan, Clinical Study Reports, etc
Authors evidence generation initiatives, incl. Journal Clubs, Scientific Communication newsletters, etc
Supports the response to Deficiency Letters from NMPA
Challenges conclusions when necessary. Independently resolves document content issues and questions from external and internal reviewers and ensures timely approvals from all approvers
Delivers high-quality deliverables and requires limited revision rounds including Pre-/Post-Market Clinical Study documents, and other medical writing efforts, etc
Provides in-depth readings into clinical evaluation regulations, technical guidance, and medical device regulations etc. as required
Works on other tasks and projects as assigned
Primary point of contact with site staff, and is responsible for managing the site throughout all phases of the clinical study, including selection and initiation of sites, as well as conducting and closing activities of the appointed studies
Administers protocol and related study training to assigned sites, evaluates the quality and integrity of study site practices related to proper conduct of the protocol and adherence to applicable regulations
Manages the progress of assigned studies by tracking regulatory submissions and approvals, study enrollment, data completion and submission, as well as resolution of data discrepancies
Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans. May serve as subject matter expert in audits
Verifies that the research site personnel, including the investigators, are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements
Ensures reporting of adverse events from research site staff to the sponsor and the IRB/IEC
Verifies that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents (source data verification)
Reviews accuracy and completeness of site records (site study file, query resolution, and other data collection tools)
Verifies Investigational Product accountability
Completes reporting and ensures management and resolution of all these activities (e.g., visit reports, trial management tracking system, pre-confirmation letter, follow-up letter, etc.)
Conducts routine monitoring visits on behalf of the clinical trial sponsor
Prepares informed consent documents
Completes clinical project deliverables per schedule
Ensures audit-readiness for assigned study sites
Communicates relevant information to the PM/LCRA in a timely manner
Contacts sites on a consistent basis to assess study compliance
Identifies and addresses noncompliance issues at investigative sites, assist with CAPA, if necessary
Tracks Screening & Enrollment and identify issues and propose solutions
Participates in the conduct and training at Investigator Meetings
Maintains expertise in regulations for China and different types of studies (pre-market, post-market, etc.)
Generates status reports, oversees process payments, maintain device and regulatory document tracking systems, patient and Case Report Form (CRF) files, required regulatory documents, and central files
Collects and tracks relevant documentation

Responsibilities

Perform formal literature searches, and succinctly summarize scientific content for assigned projects (Medical Writing)
Participate in post-market surveillance activities by conducting routine systematic literature reviews for specific medical device groups or sub-groups (Medical Writing)
Author integrated safety/performance data summaries and reports including China Clinical Evaluation Reports per regulation requirements (Medical Writing)
Author Pre-/Post-Market Clinical Study documents and other medical writing efforts including Clinical Investigational Plan, Clinical Study Reports, etc. (Medical Writing)
Author evidence generation initiatives, incl. Journal Clubs, Scientific Communication newsletters, etc. (Medical Writing)
Support the response to Deficiency Letters from NMPA (Medical Writing)
Challenge conclusions when necessary, independently resolve document content issues, and ensure timely approvals (Medical Writing)
Deliver high-quality deliverables with limited revision rounds (Medical Writing)
Provide in-depth readings into clinical evaluation regulations, technical guidance, and medical device regulations as required (Medical Writing)
Work on other tasks and projects as assigned (Medical Writing)
Serve as primary point of contact with site staff and manage sites throughout all phases of the clinical study (Clinical Operations)
Administer protocol and related study training to sites and evaluate site practices (Clinical Operations)
Manage study progress by tracking regulatory submissions, enrollment, data completion, and discrepancies (Clinical Operations)
Create and maintain documentation on site management, monitoring findings, and action plans; serve as SME in audits (Clinical Operations)
Verify site personnel conduct studies per protocol, GCP, and regulations (Clinical Operations)
Ensure reporting of adverse events to sponsor and IRB/IEC (Clinical Operations)
Perform source data verification for CRFs/eCRFs (Clinical Operations)
Review accuracy and completeness of site records (Clinical Operations)
Verify Investigational Product accountability (Clinical Operations)
Complete reporting and manage resolution of activities like visit reports and tracking systems (Clinical Operations)
Conduct routine monitoring visits on behalf of the sponsor (Clinical Operations)
Prepare informed consent documents (Clinical Operations)
Complete clinical project deliverables per schedule (Clinical Operations)
Ensure audit-readiness for assigned study sites (Clinical Operations)
Communicate relevant information to PM/LCRA timely (Clinical Operations)
Contact sites consistently to assess compliance (Clinical Operations)
Identify and address noncompliance, assist with CAPA (Clinical Operations)
Track Screening & Enrollment, identify issues, propose solutions (Clinical Operations)
Participate in conduct and training at Investigator Meetings (Clinical Operations)
Maintain expertise in China regulations and study types (Clinical Operations)
Generate status reports, oversee payments, maintain tracking systems and files (Clinical Operations)
Collect and track documentation (Clinical Operations)

Skills

Medical Writing

Literature Review

Systematic Literature Reviews

Clinical Study Reports

Post-Market Surveillance

Site Management

Protocol Training

Clinical Operations

Regulatory Compliance

NMPA Regulations

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees