Fsp-Cra Ii (Beijing)

2+ years

Not Disclosed

Beijing

10 Oct. 30, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Overview

Fortrea is a leading global contract research organization (CRO) with a commitment to scientific rigor and decades of clinical development experience. We provide a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas for pharmaceutical, biotechnology, and medical device customers. Operating in over 90 countries, Fortrea is dedicated to transforming drug and device development for partners and patients worldwide.

Essential Job Duties

Site Monitoring: Oversee all aspects of study site monitoring, including routine monitoring and close-out of clinical sites, maintenance of study files, and conducting pre-study and initiation visits. Liaise with vendors and perform additional duties as assigned.
Site Management: Manage all site management tasks as prescribed in project plans.
On-Site Monitoring: Ensure study staff receive the necessary materials and instructions for safely enrolling patients in the study.
Patient Protection: Verify adherence to informed consent procedures and protocol requirements in compliance with applicable regulations.
Data Integrity: Conduct careful source document reviews to ensure the accuracy of data submitted on Case Report Forms (CRFs) and other data collection tools.
Data Monitoring: Monitor data for any missing or implausible entries.
Resource Management: Ensure efficient use of Sponsor and Fortrea resources, adhering to SOPs and established guidelines, including economical travel management.
Audit Readiness: Maintain site-level audit readiness.
Travel Requirements: Travel, including air travel, is an essential function of this role.
Reporting: Prepare accurate and timely trip reports.
Registry Management: Manage all aspects of registry tasks as specified in project plans.
Feasibility Work: Conduct feasibility assessments when requested.
Quality Control: Participate in and follow up on Quality Control Visits (QC) as required.
Investigator Recruitment: Assist in recruiting potential investigators, preparing EC submissions, and notifying regulatory authorities.
SAE Tracking: Track and follow up on Serious Adverse Event (SAE) reporting, including report production and narrative follow-ups.
CRF Review: Independently perform CRF reviews, query generation, and resolution against established data review guidelines.
Training: Assist in training new employees, including co-monitoring.
Project Coordination: Coordinate designated clinical projects as a Local Project Coordinator and may act as a local client contact as assigned.
Additional Duties: Perform other duties as assigned by management.

Experience

Minimum Required:

At least 1 year of clinical monitoring experience is preferred, or an equivalent combination of education and experience.
Ability to independently monitor study sites according to protocol guidelines, SOPs, and local regulations.
Comprehensive understanding of Serious Adverse Event (SAE) reporting processes.
Strong planning, organization, and problem-solving skills.
Ability to work with minimal supervision.
Excellent communication and interpersonal skills.
Good analytical and negotiation abilities.
Computer competency.
Fluent in the local office language and English, both written and verbal.
Works efficiently in a matrix environment.

Education/Qualifications/Certifications

Minimum Required:

University or college degree, or certification in a related allied health profession from an accredited institution (e.g., nursing licensure). Equivalent experience can be considered.
Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements.
In-depth knowledge of monitoring procedures.
Basic understanding of the clinical trial process.
Valid Driver’s License.

Join Us

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment to revolutionizing the development process ensures the swift delivery of life-changing therapies to patients in need. Join our exceptional team and thrive in a collaborative environment that nurtures personal growth and enables you to make a meaningful global impact.

Equal Opportunity Employer

Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in our workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to race, religion, gender, sexual orientation, age, or any other legally protected characteristic. We encourage all to apply.

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Fsp-Cra Ii (Beijing)

Job Description

Company Overview

Essential Job Duties

Experience

Education/Qualifications/Certifications

Join Us

Equal Opportunity Employer

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