FSPx CRA II (Wuhan/Fuzhou)

Hiring By - Biostaffic

 BioPharma

China

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Essential Job Duties
The below statement are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.
  • Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
  • Responsible for all aspects of site management as prescribed in the projects plans General on-site monitoring responsibilities
  • Ensure the study staff who will conduct the protocol have received the proper material and instructions to safety enter patients into the study
  • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
  • Ensure the integrity of the data submitted on Case Report Forms(CRFs) or other data collection tools by careful source document review Monitor data for missing or implausible data
  • Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy
  • Ensure audit readiness at the site level Travel, including air travel, may be required and is an essential function of the job
  • Prepare accurate and timely trip reports
  • Responsible for all aspects of registry management as prescribed in the project plans
  • Undertake feasibility work when requested
  • Participate in and follow up on Quality Control Visit(QC) when requested
  • Recruitment of potential investigators, preparation of EC submissions, notification to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by supervisor
  • Might be requested to work in a client facing environment
  • Track and follow up on Serious Adverse Event(SAE) reporting, process production of reports, narratives and follow up of SAE Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
  • Assist with training, mentoring and development of new employees, e.g. co-monitoring Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned Perform other duties as assigned by management
Experience
Minimum required:
  • At minimum of 1(One) year of clinical monitoring experience is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted
  • Ability to monitor study sites independently according to protocol monitoring guidelines, SOP and local regulatory Guidelines
  • Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • Good planning, organization and problem solving skills
  • Ability to work with minimal supervision
  • Good communication and interpersonal skills
  • Good analytical and negotiation skills
  • Computer competency
  • Fluent in local office language and in English, both written and verbal
  • Works efficiently and effectively in a matrix environment
Education/Qualifications/Certifications And Licenses
Minimum Required:
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
  • Thorough knowledge of ICH Guidelines and understanding of local regulatory requirement
  • Thorough knowledge of monitoring procedures
  • Basic understanding of the clinical trial process
  • Valid Driver’s License
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • China

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 12, 2024
Company Overview
Fortrea
Fortrea

Current Openings: 0

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team of approximately 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
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