Senior Clinical Research Associate I

7 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 numerous therapeutic areas.

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 clinical site monitoring, including routine site assessments and study close-out procedures.
  • Maintain study documentation and conduct pre-study and initiation visits.
  • Collaborate with vendors and perform additional tasks as assigned.
  • Manage site operations as outlined in project plans.
  • Ensure that study personnel have received appropriate materials and instructions for safe patient enrollment.
  • Protect study participants by confirming adherence to informed consent processes and protocol requirements in line with regulatory standards.
  • Verify the accuracy of data submitted on Case Report Forms (CRFs) through meticulous source document reviews.
  • Monitor data for any discrepancies or missing information.
  • Utilize resources efficiently to perform monitoring tasks according to established SOPs and guidelines, including economical travel management.
  • Maintain audit readiness at the site level.
  • Travel may be required as part of the role.
  • Prepare detailed and timely trip reports.
  • Assist in managing small projects under the guidance of a Project Manager/Director.
  • Act as the lead monitor for specific protocols or projects and contribute to the development of monitoring plans and trip report reviews.
  • Review project progress and initiate actions to meet objectives.
  • Organize and present at Investigator Meetings.
  • Participate in protocol and Case Report Form development as needed.
  • Contribute to writing clinical trial reports as assigned.
  • Engage with internal teams to assess needs, resources, and timelines.
  • Serve as the point of contact for clinical trial supplies and vendors as assigned.
  • Manage registry activities as outlined in project plans.
  • Conduct feasibility assessments when requested.
  • Perform Quality Control Visits (QC) and follow up as needed.
  • Recruit potential investigators and assist with regulatory submissions and notifications.
  • Negotiate study budgets with investigators and support the legal department with agreements.
  • Track and follow up on Serious Adverse Event (SAE) reporting and manage related documentation.
  • Independently conduct CRF reviews and resolve queries based on established data review guidelines.
  • Assist in training and mentoring new staff members.
  • Coordinate designated clinical projects as a Local Project Coordinator under supervision, if applicable.
  • Perform other duties as assigned by management.

Experience:

Minimum Required:

  • Two (2) years of experience in clinical monitoring.
  • Comprehensive understanding of Serious Adverse Event (SAE) reporting and related processes.
  • Advanced skills in site monitoring and management.
  • Proficient in registry administration.
  • Ability to work independently with minimal supervision.
  • Strong planning and organizational skills.
  • Proficient computer skills with knowledge of various software applications.
  • Excellent verbal and written communication abilities.
  • Capability to train and supervise junior staff.
  • Problem-solving skills and ability to prioritize workload effectively.
  • Ability to collaborate within a project team.
  • Efficiently operate in a matrix environment.
  • Valid Driver's License.

Education/Qualifications/Certifications and Licenses:

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 successfully fulfill the key responsibilities of the role.

SHA Fortrea is actively seeking dedicated problem-solvers and innovative thinkers who share our commitment to overcoming challenges in clinical trials. We are devoted to transforming the development process, ensuring the timely delivery of impactful therapies to patients in need. Join our exceptional team and thrive in a collaborative environment that fosters personal growth, enabling you to make a significant global impact.

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