FSP Clinical Research Associate - Changchun, Shenyang
No salary listed
Mid
Bachelor's
Beijing, China
In PersonTravel to study sites is required 60% of the time.
Biology & BiotechClinical Research Operations
About the job
Requirements
- A university or college degree, or certification in a related allied health profession from an appropriately accredited institution (for example, nursing licensure); equivalent experience may be substituted.
- A minimum of two years of Clinical Monitoring experience is required for external candidates; internal candidates must have a minimum of two years of Clinical Monitoring experience.
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
- Thorough knowledge of monitoring procedures and a basic understanding of the clinical trial process.
- Fluency in the local office language and English, both written and verbal.
- Ability to monitor study sites independently according to the monitoring plan, project requirements, Standard Operating Procedures, and ICH GCP guidelines.
- Ability to work with minimal supervision.
- Understanding of Serious Adverse Event reporting, including producing reports and narratives and following up on Serious Adverse Events.
- Ability to sit at a computer for long periods and use hands to handle objects, tools, or controls, including a computer keyboard, for up to eight hours per day.
Responsibilities
- Manage clinical study sites according to Fortrea Standard Operating Procedures, ICH GCP Guidelines, project plans, and Sponsor requirements, including verification of study training records.
- Conduct clinical trial site monitoring, including pre-study, site initiation, process monitoring, routine monitoring, and close-out visits.
- Prepare and implement project plans related to clinical monitoring responsibilities.
- Protect study subjects by verifying informed consent procedures and adherence to protocol and applicable regulatory requirements.
- Safeguard data integrity through source document review and verification, query generation, and query resolution using Fortrea or client data management systems.
- Confirm that site regulatory documents and applicable electronic Trial Master File and Sponsor documents remain complete and current throughout the trial.
- Maintain accurate inventory and accountability of investigational products and ensure study materials are stored securely and according to protocol requirements.
- Ensure adherence to global quality control and CRA performance metrics and maintain audit readiness at the site level.
- Act as Lead CRA on the project when assigned.
- Ensure study staff receive the materials and instructions needed to safely enroll subjects or patients, and verify eligibility, screening, informed consent, protocol adherence, and regulatory compliance.
- Review source data integrity and monitor data for missing or implausible information.
- Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations, and discrepancies and initiate corrective action as required.
- Perform required monitoring tasks efficiently according to Standard Operating Procedures and established guidelines, including managing travel expenses according to Fortrea travel policy.
- Travel, including air travel, to study sites as required; travel is an essential job function and is required 60% of the time.
- Prepare and submit accurate and timely trip reports.
- Perform electronic case report form review, 100% source data verification, query generation, and resolution on Fortrea or client data management systems, with or without direct supervision, as assigned by management.
- Assist with clinical research project administration, investigator recruitment when applicable, collection of investigator documentation, and site management.
- Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools and eClinical systems.
- Track investigational product shipments and supplies as needed.
- Track and follow up on serious adverse events as assigned.
- Coordinate with the study team and align monitoring with critical study timelines to meet study deliverables.
- Prepare and implement study-specific monitoring plans and site initiation slides as assigned.
- Attend investigator meetings when applicable, project team meetings, teleconferences, and other meetings as needed.
- Present training content for site initiation.
- Assist with training new employees, including co-monitoring.
- Perform other duties as needed or assigned.
- Work in a standard office and/or home working environment, and in clinical research unit and hospital environments for administrative work; work outside normal office hours as required.
Desired Qualifications
- Thorough working knowledge of Fortrea Standard Operating Procedures for site monitoring.
- At least one additional year of experience in a related field, such as medical, clinical, pharmaceutical, laboratory, research, data analysis, data management, or technical writing.
- Phase I monitoring experience.
- Life Science or Nursing qualification.
- Specific skills, systems, certifications, and/or licenses relevant to the position.
- Attention to detail and a methodical approach to work.
- Understanding of medical and clinical research terminology and clinical research processes.
- Understanding of the basics of physiology, pharmacology, and medical devices when applicable.
- Understanding of ICH GCP principles, ISO 14155 when applicable, and local regulatory requirements.
- Computer literacy, including working knowledge of personal computers, Windows, and Microsoft Office applications.
- Oral and written communication with internal and external contacts, interpersonal and organizational skills, personal presentation, and effective communication in English.
- Ability to maintain confidentiality of data and information when interacting with staff at all levels and across studies and Sponsors.
- Ability to conduct clinical operations activities effectively and efficiently.
- Analytical and negotiation skills.
- Experience using eClinical systems, such as a clinical trial management system.
- For medical device positions, experience providing customer service to device end users.
About the company
Fortrea is a global contract research organization that provides clinical development services for the life sciences industry. It offers full service, functional service, and hybrid outsourcing models across Phase I–IV trials, clinical pharmacology, and consulting, serving biotech, biopharma, medical devices, and diagnostics. Its work is delivered through a network of investigators and specialized teams in approximately 100 countries, supporting trial design, execution, data management, and regulatory compliance. Fortrea’s approach combines its legacy experience from Covance and Labcorp with a pureplay CRO model to deliver fit-for-purpose solutions and agile project delivery. This positions it to manage trials across more than 20 therapeutic areas with scientific rigor and operational excellence. The company aims to bring predictability to clinical trial execution and help clients turn research ideas into real-world outcomes.
Company Size
10,001+
Company Stage
IPO
Headquarters
Winston-Salem, North Carolina
Founded
2023
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Simplify's Take
What believers are saying
- Q2 2026 revenue beat estimates at $678.2 million, lifting full-year guidance.
- Book-to-bill hit 1.06x in Q2, signaling improving demand after biotech recovery.
- Knoblauch returned September 9, 2026, restoring dedicated CFO leadership after litigation.
What critics are saying
- Fortrea's revenue still fell 4.5% in Q2, exposing fragile organic growth.
- FSP headwinds continue, and management cited flat second-half performance after Q2.
- Another CFO lawsuit or compliance dispute shatters buyer trust across Fortrea's pipeline.
What makes Fortrea unique
- Fortrea owns early-phase capabilities after buying Worldwide's CPU and bioanalytical lab in Texas.
- Its 100-country footprint and 20-therapeutic-area depth support global multicenter trials.
- Three decades of clinical development experience gives Fortrea credibility with biopharma sponsors.
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Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- 401(k) Retirement Plan
- 401(k) Company Match
- Unlimited Paid Time Off
- Paid Vacation