Description
We are seeking a Clinical Research Site Monitor to perform monitoring and site management work for a variety of protocols, site and therapeutic areas. As a Site Monitor, you will be responsible for ensuring that clinical trials are conducted in accordance with Good Clinical Practice (GCP) and regulatory requirements.
Responsibilities
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements
- Work with sites to adapt, drive and track subject recruitment plans in line with project needs to enhance predictability
- Administer 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
- 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 (as required) 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 / ICH and local regulatory requirements
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Act as a mentor for clinical staff including conducting co-monitoring and training visits
- Collaborate and liaise with study team members for project execution support as needed
Requirements
- Bachelor's Degree in a scientific discipline or health care preferred
- At least 3 years of on-site monitoring experience
- In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Strong therapeutic and protocol knowledge as provided in company training
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
- Written and verbal communication skills including good command of English language
- Effective time and financial management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients