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:
- Conduct site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Collaborate with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability
- Provide protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations, escalating quality issues as needed
- Manage 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
- Ensure copies/originals of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
- Create and maintain documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Collaborate with study team members for project execution support as needed
- Support development of project subject recruitment plans on a per site basis, if applicable
- Manage site finances according to executed clinical trial agreements and retrieve invoices according to local requirements, if applicable
Qualifications:
- Bachelor's degree in a scientific discipline or healthcare
- At least 1 year of on-site monitoring experience
- Equivalent combination of education, training and experience may be accepted in lieu of degree
- Good 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 use of a laptop computer and iPhone and iPad (where applicable)
- Excellent written and verbal communication skills, including good command of English language
- Strong organizational and problem-solving skills
- Effective time and financial management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients