Field Solutions Partner Clinical Research Associate 2
No salary listed
Mid
Bachelor's
Beijing, China
HybridTravel 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, such as nursing licensure; equivalent experience may be substituted as appropriate.
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
- Thorough knowledge of monitoring procedures.
- Basic understanding of the clinical trial process.
- Fluency in the local office language and English, both written and verbal.
- External candidates must have at least 2 years of Clinical Monitoring experience and a university or college degree, or certification in a related allied health profession from an appropriately accredited institution.
- Internal candidates must have at least 2 years of Clinical Monitoring experience.
- Ability to monitor study sites independently according to the monitoring plan, project requirements, SOPs, and ICH GCP guidelines.
- Ability to work with minimal supervision.
- Understanding of Serious Adverse Event reporting, report and narrative production, and SAE follow-up.
- Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors.
- Ability to conduct clinical operations activities effectively and efficiently.
- Good analytical and negotiation skills.
- Ability to sit at a computer for long periods and use hands to operate a computer keyboard and other tools for up to 8 hours per day.
- Ability to work outside normal office hours as required.
- Willingness and ability to travel to study sites 60% of the time; travel, including air travel, is an essential function.
Responsibilities
- Manage clinical study sites according to Fortrea SOPs, ICH GCP Guidelines, applicable project plans, and Sponsor requirements, including verifying study training records.
- Conduct clinical trial site monitoring, including pre-study, site initiation, process monitoring, routine monitoring, and close-out visits, according to SOPs, ICH guidelines, and GCP.
- Prepare and implement project plans related to clinical monitoring responsibilities.
- Protect study subjects by verifying informed consent procedures and protocol requirements alongside applicable regulatory requirements.
- Safeguard data integrity through source document review and verification, query generation, and resolution using established data review guidelines and Fortrea or client data management systems.
- Confirm site regulatory documents and applicable eTMF/Sponsor documents are complete and current throughout the trial.
- Ensure investigational product inventory and accountability are accurate and study materials are stored securely and according to protocol requirements.
- Ensure adherence to global quality control and CRA performance metrics.
- Ensure audit readiness at the site level.
- Act in the project role of Lead CRA when assigned.
- Ensure study staff conducting the protocol have received appropriate materials and instructions before enrolling subjects or patients.
- Perform eligibility review and verify screening, informed consent procedures, and protocol requirements against applicable regulatory requirements.
- Review source data and monitor data for missing or implausible entries.
- 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 SOPs and established guidelines, including managing travel expenses economically according to Fortrea travel policy.
- Prepare and submit accurate and timely trip reports.
- Perform eCRF review, 100% source data verification, query generation, and query resolution according to established data review guidelines, 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, for example through co-monitoring.
- Perform other duties as needed or assigned.
- Sit at a computer and use a keyboard and other tools in standard office or home working environments, clinical research units, and hospitals in administrative settings.
Desired Qualifications
- Thorough working knowledge of Fortrea SOPs 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.
- Good attention to detail and a methodical approach to work.
- Good understanding of medical and clinical research terminology and clinical research processes.
- Understanding of basic physiology, pharmacology, and medical devices when applicable.
- Good understanding of ICH GCP principles, ISO 14155 when applicable, and local regulatory requirements.
- Computer literacy and working knowledge of PCs, Windows, and Microsoft Office applications.
- Oral and written communication in English and effective internal and external communication.
- Experience using e-clinical systems, such as a clinical trial management system (CTMS).
- 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