NV_Senior Clinical Research Associate_Shanghai at Stryker

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, Clinical ResearchIndustries

Requirements

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 of regional clinical study regulations is required
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

Responsibilities

Monitors assigned clinical trials to ensure data integrity and adherence to China regulations, company policies, and applicable procedures
Serves as primary point of contact with site staff, managing the site throughout all phases of the clinical study, including selection, initiation, conducting, and closing activities
Establishes cross-functional and KOL relationships, monitors and/or supervises monitoring activities of assigned clinical trials
Verifies that research site personnel, including investigators, conduct 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 data in Case Report Forms (CRFs/eCRFs) agree with 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 activities (e.g., visit reports, trial management tracking system)
Conducts routine monitoring visits on behalf of the clinical trial sponsor
Prepares manual of operations for study sites
Prepares 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
Identifies and addresses noncompliance issues at investigative sites, assists with CAPA if necessary
Tracks Screening & Enrollment, identifies issues, and proposes 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, maintains device and regulatory document tracking systems, patient and 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, 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 supports the Quality Policy by building quality into all aspects of work and maintaining compliance to all quality requirements
Completes all training requirements on time
Plans own work assignments; may plan and/or delegate work to others

Skills

Key technologies and capabilities for this role

GCPICH GuidelinesClinical Trial MonitoringSource Data VerificationAdverse Event ReportingCRF RevieweCRFSite ManagementInvestigational Product AccountabilityRegulatory ComplianceKOL RelationshipsVisit Reports

Questions & Answers

Common questions about this position

What is the work arrangement for this position?

The position offers a hybrid work flexibility.

What are the key responsibilities of this role?

The role involves monitoring clinical trials for data integrity and adherence to China regulations, managing sites throughout study phases, verifying protocol compliance, source data verification, and ensuring adverse event reporting.

What skills or expertise are essential for this position?

Essential expertise includes knowledge of China regulations, ICH/GCP principles, Stryker SOPs, clinical trial monitoring, source data verification, and regulatory document management.

Is the position full-time?

Yes, this is a full-time position.

What makes a strong candidate for this Senior Clinical Research Associate role?

Strong candidates will have experience independently managing complex global neurovascular studies, expertise in China regulations and GCP, and skills in site monitoring, regulatory compliance, and cross-functional relationship building.

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

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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