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Clinical Trial Monitor II
2 months ago
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 over 20 therapeutic domains. With a workforce exceeding 19,000 professionals operating in more than 90 countries, SHA Fortrea is reshaping the landscape of drug and device development for partners and patients worldwide.
Key Responsibilities
1) The following points outline the essential nature of the role and are not an exhaustive enumeration of all tasks, skills, and responsibilities.
2) Oversee all facets of study site monitoring, including routine monitoring and closure of clinical sites, management of study documentation, execution of pre-study and initiation visits; collaborate with vendors; and undertake additional tasks as assigned.
3) Manage all aspects of site operations as delineated in the project plans.
4) General On-Site Monitoring Duties.
5) Ensure that study personnel conducting the protocol have received the necessary materials and instructions to safely enroll patients in the study.
6) Safeguard the rights of study participants by confirming adherence to informed consent procedures and protocol requirements in accordance with applicable regulatory standards.
7) Maintain the integrity of data submitted on Case Report Forms (CRFs) or other data collection instruments through meticulous source document examination.
8) Monitor data for any missing or implausible entries.
9) Ensure that the resources of the Sponsor and SHA Fortrea are utilized efficiently by executing the required monitoring tasks in a timely manner, in line with SOPs and established guidelines, including managing travel expenses in a cost-effective manner according to SHA Fortrea travel policies.
10) Maintain audit readiness at the site level.
11) Travel, including air travel, may be a necessary component of the role.
12) Prepare accurate and prompt trip reports.
13) Manage all aspects of registry operations as outlined in the project plans.
14) Conduct feasibility assessments when requested.
15) Participate in and follow up on Quality Control Visits (QC) as required.
16) Engage 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 the supervisor.
17) May be required to operate in a client-facing capacity.
18) Track and follow up on Serious Adverse Event (SAE) reporting, manage the production of reports, narratives, and follow-up of SAEs.
19) Independently conduct CRF reviews; generate and resolve queries based on established data review guidelines on SHA Fortrea or client data management systems as assigned by management.
20) Assist in the training of new employees, such as through co-monitoring.
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 other duties as assigned by management.
Experience
Minimum Required:
- A minimum of one year of clinical monitoring experience is preferred, or an equivalent combination of education and experience to effectively fulfill the key responsibilities of the role may be considered.
- Capability to independently monitor study sites in accordance with protocol monitoring guidelines, SOPs, and local regulatory requirements.
- Comprehensive understanding of Serious Adverse Event (SAE) reporting, report generation, narrative creation, and follow-up of SAEs.
- Strong planning, organizational, and problem-solving abilities.
- Ability to work with minimal supervision.
- Excellent communication and interpersonal skills.
- Proficient analytical and negotiation skills.
- Computer literacy.
- Fluency in the local office language and English, both written and verbal.
- Effective and efficient operation in a matrix environment.
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). An equivalent amount of experience may be considered as appropriate.
- In-depth knowledge of ICH Guidelines and an understanding of local regulatory requirements.
- Thorough knowledge of monitoring procedures.
- Basic understanding of the clinical trial process.
- Valid Driver's License.
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 revolutionize the development process, ensuring the rapid delivery of transformative ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative environment where personal growth is fostered, enabling you to make a significant global impact.
