NV_Senior Clinical Research Associate_Shanghai

Position summary:

• Monitors assigned clinical trials to ensure data integrity and adherence to China regulations, company policies, and any other applicable procedures.

• 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.

• Establishes cross-functional and KOL relationships, monitors and/or supervises the monitoring activities of assigned clinical trials to ensure data integrity and adherence to China regional regulations, company policies, and any other applicable procedures.

• Responsible for supporting compliance with applicable Regulations, ICH/GCP principles, Stryker SOPs, and timely completion of complex global neurovascular studies

Essential Duties & Responsibilities: (Detailed Description)

• Verify that the research site personnel, including the investigators, are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements

• Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC

• Verify that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents (source data verification);

• Review accuracy and completeness of site records (site study file, query resolution, and other data collection tools);

• Verify Investigational Product accountability;

• Complete reporting and ensure management and resolution of all these activities (e.g., visit reports, trial management tracking system);

• Conduct routine monitoring visits on behalf of the clinical trial sponsor.

• Prepare manual of operations for study sites

• Prepare informed consent documents

• Completes clinical project deliverables per schedule

• Ensures audit-readiness

• Communicates relevant information to the PM/LCTS in a timely manner

• Contacts sites on a consistent basis to assess study compliance

• Identify and address noncompliance issues at investigative sites, assist  with CAPA, if necessary

• Tracks Screening & Enrollment and identify issues and propose solutions.

• Independently confirms that site documents match Study Master File

• 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 regulatory documents (e.g., confidentiality disclosures, IRB approvals, investigator agreements, contracts, study/project annual reports and financial disclosures) to/from study sites using company specific database

• Reviews and collects documents to compile Clinical Events Committee (CEC) packets for CEC adjudication meetings

• Assembles and tracks metrics data.

• Mentors and trains CTCs

• Recommends process improvements to increase team efficiencies and effectiveness.

• Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements Complete all training requirements on time

• Plans own work assignments; may plan and/or delegate work to others

Education & Experience:

• Bachelor's level degree or equivalent in science or health care field with at least 2 years of relevant clinical research experience.              

• Fundamental knowledge and good understanding of GCPs, clinical study development process, etc.

• 1+ year monitoring experience in a China clinical study is required

• Working knowledge into regional clinical study regulations is required

Other Requirements:

• Workable verbal/written English

• NMPA medical device GCP or drug GCP certification is required

• Strong interpersonal, written and oral communication, organization, and planning skills

• Regulatory Affairs experience is a plus

• MNC or international CRO background is a plus

• Project Management Certification, CCRA Certification is a plus