Description
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Responsibilities include:
- Conducting site monitoring visits in accordance with contracted scope of work and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Collaborating with sites to adapt, drive and track subject recruitment plans in line with project needs to enhance predictability
- Providing protocol and related study training to assigned sites and establishing regular lines of communication to manage ongoing project expectations and issues
- Evaluating the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations, and escalating quality issues as needed
- Managing the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
- Ensuring site documents are available for filing in the Trial Master File (TMF) and verifying that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements
- Creating and maintaining documentation regarding site management, monitoring visit findings and action plans
- Collaborating with study team members for project execution support as necessary
Requirements:
- Bachelor's Degree in a scientific discipline or healthcare
- 6 months to 2 years of on-site monitoring experience, including monitoring visits and preparation of monitoring reports
- Availability to travel
- Residence in Lima, Peru
- Excellent written and verbal communication skills, including a good command of English
- Basic knowledge of and skill in applying applicable clinical research regulatory requirements (GCP and ICH guidelines)
- Good therapeutic and protocol knowledge, as provided in company training
- Proficiency in Microsoft Word, Excel and PowerPoint, and experience with laptops, iPhones and iPads
- Strong organizational and problem-solving skills, effective time and financial management skills, and ability to establish and maintain effective working relationships