Job Description
- Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit reports.
- Monitor the progress of clinical study sites participating in a clinical study, and to assure the protocol is followed and data is reported accurately.
- Evaluate the quality and integrity of the reported data, site efficacy and investigational product (IP) management.
- Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol.
- Develop patient recruitment strategies in conjunction with the clinical site to meet enrolment timelines, while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s).
- Assure that adverse events are correctly documented and reported.
- Ensure proper transmission of clinical case data to the data management centers, review case reports questions and problems and clarify or obtain alterations to data as appropriate.
Qualifications
- Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
- Ability to perform all clinical monitoring activities independently.
- Strong interpersonal, written, and verbal communication skills within a matrixed team.
- Experience working in a self-driven capacity, with a sense of urgency and limited oversight.
- Good time management and ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s).
- Strong computer skills, including but not limited to the knowledge of an electronic data capture systems (EDC), Electronic Trial Master File (eTMF), Clinical Trial Management System (CTMS), and MS-Office products such as Excel and Word.
- BSc or MSc in relevant field. A lower educational credential may be considered if candidate has ample monitoring experience.