Clinical Research Specialist I

6 days ago

Shanghai, Shanghai, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full time

As a prominent global contract research organization (CRO) dedicated to scientific excellence and extensive clinical development expertise, SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch offers pharmaceutical, biotechnology, and medical device clients a comprehensive array of clinical development, patient access, and technological solutions across various therapeutic areas. With a workforce exceeding 19,000 professionals operating in over 90 countries, SHA Fortrea is reshaping the landscape of drug and device development for partners and patients worldwide.

Key Responsibilities:

The following duties are intended to outline the general nature of the role and are not exhaustive of all responsibilities, skills, and tasks.

  • Oversee all facets of study site monitoring, including routine monitoring and closure of clinical sites, maintenance of study documentation, and conducting pre-study and initiation visits.
  • Collaborate with vendors and fulfill additional responsibilities as assigned.
  • Manage all aspects of site operations as defined in project plans.
  • Conduct on-site monitoring duties to ensure compliance with protocols.
  • Verify that study staff have received the necessary materials and instructions for safely enrolling patients in the study.
  • Ensure the protection of study participants by confirming adherence to informed consent procedures and protocol requirements in accordance with applicable regulations.
  • Safeguard the integrity of data submitted on Case Report Forms (CRFs) or other data collection tools through meticulous source document review.
  • Monitor data for any inconsistencies or missing information.
  • Utilize resources efficiently to perform required monitoring tasks in alignment with Standard Operating Procedures (SOPs) and established guidelines, including managing travel expenses responsibly.
  • Maintain audit readiness at the site level.
  • Travel, including air travel, may be necessary and is a fundamental aspect of the role.
  • Prepare precise and timely trip reports.
  • Manage small projects under the guidance of the Project Manager/Director as assigned.
  • Serve as the lead monitor for a protocol or project, assisting in the establishment of monitoring plans and reviewing trip reports as required.
  • Review project progress and initiate appropriate actions to meet target objectives.
  • Organize and present at Investigator Meetings.
  • Contribute to the development of protocols and Case Report Forms as needed.
  • Assist in writing clinical trial reports as assigned.
  • Engage with internal teams to assess needs, resources, and timelines.
  • Act as the contact for clinical trial supplies and other vendors as designated.
  • Oversee all aspects of registry management as outlined in project plans.
  • Conduct feasibility assessments when requested.
  • Perform, report, and follow up on Quality Control Visits (QC) as necessary.
  • Recruit potential investigators, prepare Ethics Committee submissions, notify regulatory authorities, translate study-related documents, organize meetings, and undertake other tasks as directed by the supervisor.
  • Negotiate study budgets with potential investigators and assist the legal department with agreements as assigned.
  • Track and follow up on Serious Adverse Event (SAE) reporting, including the production of reports and narratives.
  • Independently conduct CRF reviews, generate queries, and resolve issues according to established data review guidelines.
  • Assist in the training, mentoring, and development of new employees, including 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 Requirements:

Minimum Required:

  • Two (2) years of clinical monitoring experience.
  • Comprehensive understanding of Serious Adverse Event (SAE) reporting, including the production of reports and follow-up procedures.
  • Advanced skills in site monitoring and study management.
  • Proficient in registry administration.
  • Ability to work independently with minimal supervision.
  • Strong planning and organizational skills.
  • Proficient computer skills with a solid understanding of various software applications.
  • Excellent verbal and written communication skills.
  • Capability to train and supervise junior staff.
  • Aptitude for resolving project-related issues and prioritizing workload effectively.
  • Ability to collaborate within a project team.
  • Efficiently operate in a matrix environment.
  • Valid Driver's License.

Education and Qualifications:

Minimum Required:

  • A university or college degree, or certification in a related allied health profession from an accredited institution (e.g., nursing licensure).
  • Alternatively, candidates with a minimum of 6 years of recent clinical monitoring experience will be considered.
  • Thorough knowledge of regulatory requirements and the drug development process.
  • Fluency in the local office language and English, both written and verbal.
  • Or an equivalent combination of education and experience to effectively perform the key responsibilities of the role.

SHA Fortrea is actively seeking motivated problem-solvers and innovative thinkers who share our commitment to overcoming challenges in clinical trials. Our steadfast dedication is to transform the development process, ensuring the rapid delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative environment that fosters personal growth, enabling you to make a significant global impact.

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