Clinical Research Associate II

2 months ago

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

As a prominent global contract research organization (CRO), SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is dedicated to scientific excellence and possesses extensive experience in clinical development. We offer a comprehensive array of clinical development, patient access, and technological solutions across numerous therapeutic domains.

Key Responsibilities

1) The following points outline the essential functions of the role, though they are not exhaustive.

2) Oversee all elements of clinical site monitoring, including routine site assessments and study close-out procedures, management of study documentation, conducting pre-study and initiation visits, coordinating with vendors, and other assigned tasks.

3) Manage site operations as defined in project specifications.

4) Conduct general on-site monitoring duties.

5) Ensure that study personnel have received the necessary materials and guidance to safely enroll participants in the study.

6) Safeguard the rights of study participants by confirming adherence to informed consent protocols and study requirements in compliance with applicable regulations.

7) Maintain the integrity of data collected on Case Report Forms (CRFs) or other data collection instruments through meticulous review of source documents.

8) Monitor data for any inconsistencies or missing information.

9) Optimize the use of resources from both the Sponsor and SHA Fortrea by performing required monitoring tasks efficiently, in accordance with standard operating procedures (SOPs) and established guidelines, including managing travel expenses judiciously.

10) Ensure readiness for audits at the site level.

11) Travel, including air travel, is a necessary component of this role.

12) Prepare accurate and timely reports following site visits.

13) Oversee all aspects of registry management as outlined in project plans.

14) Conduct feasibility assessments when required.

15) Participate in and follow up on Quality Control Visits (QC) as needed.

16) Assist in the recruitment of potential investigators, preparation of ethics committee submissions, notifications to regulatory bodies, translation of study-related documents, organization of meetings, and other tasks as directed by supervisors.

17) May be required to engage in client-facing activities.

18) Track and manage Serious Adverse Event (SAE) reporting, including the preparation of reports and follow-up actions.

19) Independently conduct CRF reviews, generate queries, and resolve issues according to established data review protocols on SHA Fortrea or client data management systems as assigned.

20) Assist in training new staff, such as through co-monitoring activities.

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

22) Perform additional duties as assigned by management.

Experience Requirements

Minimum Qualifications:

• A minimum of one year of clinical monitoring experience is preferred, or an equivalent combination of education and experience that enables successful performance of the key responsibilities of the role.

• Ability to independently monitor study sites in accordance with protocol monitoring guidelines, SOPs, and local regulatory requirements.

• Comprehensive understanding of Serious Adverse Event (SAE) reporting, including the preparation of reports and follow-up procedures.

• Strong planning, organizational, and problem-solving skills.

• Ability to work with minimal supervision.

• Excellent communication and interpersonal skills.

• Strong analytical and negotiation abilities.

• Proficient in computer applications.

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

• Capable of working efficiently and effectively in a matrix environment.

Educational Qualifications

Minimum Required:

• A university or college degree, or certification in a related allied health profession from an accredited institution (e.g., nursing licensure). Equivalent experience may be considered.

• In-depth knowledge of ICH Guidelines and local regulatory requirements.

• Thorough understanding of monitoring procedures.

• Basic comprehension of the clinical trial process.

• Valid Driver's License.

SHA Fortrea is actively seeking motivated individuals who are passionate about overcoming challenges in clinical trials. Our commitment is to enhance the development process, ensuring the timely delivery of transformative ideas and therapies to patients in need. Join our exceptional team and experience a collaborative environment that fosters personal growth and enables you to make a significant global impact.

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