FSP-CRA I

6 months ago

Beijing, China BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Full time

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:

1) Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned

2) Responsible for all aspects of site management as prescribed in the project plans

3) General On-Site Monitoring Responsibilities:

4) Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study

5) Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements

6) Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review

7) Monitor data for missing or implausible data

8) Ensure the resources of the Sponsor and Labcorp 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 Labcorp travel policy

9) Ensure audit readiness at the site level

10) Travel, including air travel, may be required and is an essential function of the job.

11) Prepare accurate and timely trip reports

12) Interact with internal work groups to evaluate needs, resources and timelines

13) Act as contact for clinical trial supplies and other suppliers (vendors) as assigned

14) Responsible for all aspects of registry management as prescribed in the project plans

15) Undertake feasibility work when requested

16) participate in and follow-up on Quality Control Visits (QC) when requested

17) Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned 18) Assist Senior CRA with managing investigator site budgets

19) Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

20) Independently perform CRF review; query generation and resolution against established data review guidelines on Labcorp or client data management systems as assigned by management

21) Assist with training, mentoring and development of new employees, e.g. co-monitoring

22) Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned

23) Perform other duties as assigned by management

Experience:

Minimum Required:

• Six (6) months experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)

• Basic understanding of Regulatory Guidelines

• Ability to work within a project team

• Good planning, organization and problem solving skills

• Good computer skills with good working knowledge of a range of computer packages

• Works efficiently and effectively in a matrix environment

• Valid Driver's License

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.

• Basic knowledge of Regulatory Guidelines

• Basic understanding of the clinical trial process

• Fluent in local office language and in English, both written and verbal

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.

  • Clinical Research Associate I

    2 weeks ago

    Beijing, Beijing, China Parexel Full time

    Job Summary: We are seeking a skilled Clinical Research Associate I (FSP) to join our team at Parexel.About the Role:Conduct Source Data Verification and Ensure Clinical Trials Data are Submitted in a Timely Fashion: The successful candidate will be responsible for conducting source data verification (SDV) and ensuring that clinical trials data are submitted...

  • Clinical Research Associate I(FSP)

    4 weeks ago

    Beijing, Beijing, China Parexel Full time

    Parexel's Clinical Research Associate I(FSP) RoleAs a Clinical Research Associate I(FSP) at Parexel, you will play a critical role in the success of our clinical trials. Your primary responsibility will be to ensure the smooth execution of studies at investigator sites, ensuring that all regulatory requirements are met and that data quality is maintained.Key...

  • Clinical Research Associate I(FSP) Coordinator

    2 weeks ago

    Beijing, Beijing, China Parexel Full time

    Unlocking Success in Clinical ResearchOur team at Parexel is dedicated to delivering exceptional results in clinical trials. As a Clinical Research Associate I(FSP), you will play a critical role in ensuring the success of our studies.Key Responsibilities:Source Data Verification and Data Management Conduct thorough source data verification and ensure timely...

  • FSP Clin Trials Admin I-Beijing

    5 months ago

    Beijing, China BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Full time

    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...

  • Sr. Clinical Research Associate

    6 months ago

    Beijing, China Novo Nordisk AS Full time

    Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join Novo Nordisk. Together we can create life-changing innovation. Together we can make it...

  • Clinical Research Associate

    2 weeks ago

    Beijing, Beijing, China BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Full time

    Job Title: FSP-SCRA I Job Summary:Fortrea is seeking a Clinical Research Associate I to support the execution of clinical trials across multiple therapeutic areas. The successful candidate will be responsible for conducting site visits, managing study documentation, and ensuring compliance with regulatory requirements.Essential Responsibilities:Conduct site...

  • Clinical Research Associate

    5 months ago

    Beijing, China Novo Nordisk Full time

       Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join  Novo Nordisk. Together we can create life-changing innovation. Together we can...

  • FSP-SCRA I

    4 months ago

    Beijing, China BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Full time

    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...

  • Clinical Research Associate Trainee

    2 weeks ago

    Beijing, Beijing, China IQVIA Full time

    Job Description:Clinical Research Associate Trainee (CRA Trainee) project is a professional talent cultivation program established by IQVIA China, based on the global training system, combining domestic business development and needs. The program aims to train and send qualified clinical monitors to business teams through efficient and professional training....

  • Clinical Research Associate I(FSP)

    2 months ago

    Beijing, China Parexel Full time

    When our values align, there's no limit to what we can achieve.   Conducts source data verification (SDV) and ensure clinical trials data are submitted to data management in a timely fashion • Identifies issues that may impact on the conduct of the study and ensure appropriate closure of all issues • Proactively manages a greater investigator...

  • Clinical Research Associate Specialist

    5 days ago

    Beijing, Beijing, China Parexel Full time

    About the RoleWe are seeking an experienced Clinical Research Associate to join our team. As a Senior Clinical Research Associate I, you will be responsible for driving study performance at sites, performing site monitoring and onsite visit activities according to the monitoring plan and in compliance with procedural documents.Key ResponsibilitiesDrive study...

  • Clinical Research Associate I(FSP) Coordinator

    24 minutes ago

    Beijing, Beijing, China Parexel Full time

    Parexel is a leading provider of clinical research services. Salary: $80,000 - $100,000 per yearJob DescriptionKey Responsibilities:Conducts source data verification (SDV) and ensures clinical trials data are submitted to data management in a timely fashionIdentifies issues that may impact on the conduct of the study and ensures appropriate closure of all...

  • Centralized Monitor

    5 months ago

    Beijing, China IQVIA Full time

    Essential Functions • Manage assigned sites and perform Subject Level Data Review independently, if required perform with both responsibilities as dual role.; • Perform remote monitoring visits for assigned sites as assigned.; • Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy...

  • Senior Clinical Research Coordinator

    13 minutes ago

    Beijing, Beijing, China IQVIA Full time

    About the RoleThis is an exciting opportunity to join our team as a Senior Clinical Research Coordinator - Global Studies. As a key member of our team, you will be responsible for providing high-quality administrative support to our clinical study management team.Key ResponsibilitiesProvide study-level administrative support to the clinical study management...

  • Clinical Trials Administrator

    4 weeks ago

    Beijing, Beijing, China BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Full time

    Job Summary: We are seeking a highly organized and detail-oriented Clinical Trials Administrator to join our team at BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd. The successful candidate will be responsible for providing administrative support to our clinical trials team, ensuring the smooth execution of studies and maintaining...