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 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 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 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 documentation regarding site management, monitoring visit findings and action plans.
- Collaborate with study team members for project execution support as needed.
Qualifications:
- Master's Degree in Life Sciences.
- CRA certification according to Ministerial requirements.
- Completion of CRA training program or prior monitoring experience.
- 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 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.
The potential base pay range for this role, when annualized, is €33,900.00 - €61,700.00.