Description
We are seeking a passionate and motivated Clinical Research Associate (CRA) to join our team and play a key role in delivering high-quality clinical trials. In this role, you will collaborate with investigator sites and cross-functional teams to ensure studies are conducted with excellence, compliance, and a patient-centered approach.
Position Overview Monitor and manage clinical trial sites to ensure studies are conducted and study data are reported in accordance with the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Conduct site monitoring visits (selection, initiation, routine monitoring, and closeout visits) in accordance with the scope of work outlined in the contract and Good Clinical Practice (GCP) guidelines.
- Work with sites to adapt, drive, and track subject recruitment plans according to project needs in order to improve predictability.
- Deliver protocol and related study training to assigned sites and maintain regular communication with sites to manage expectations and resolve ongoing project issues.
- Assess the quality and integrity of site practices related to protocol compliance and applicable regulatory requirements. Escalate quality issues as appropriate.
- 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. Support study startup activities as needed.
- Ensure copies and/or originals (as required) of site documents are filed in the Trial Master File (TMF), and verify that the Investigator Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate site management documentation, monitoring visit findings, and action plans by submitting monitoring reports, follow-up letters, and other required study documentation.
- Collaborate and coordinate with study team members to support project execution as needed.
- Support development of site-specific patient recruitment plans when applicable.
- Oversee site financial management in accordance with the signed Clinical Trial Agreement and collect invoices according to local requirements, when applicable.
Qualifications and Experience
- Bachelor's degree in a scientific or healthcare-related discipline required.
- Minimum of 2 years of on-site monitoring experience.
- An equivalent combination of education, training, and experience may also be considered.
- Strong knowledge of and ability to apply applicable clinical research regulatory requirements.
- Knowledge of Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.
- Strong understanding of therapeutic areas and study protocols, as presented through company training.
- Computer proficiency, including Microsoft Word, Excel, and PowerPoint, as well as the use of laptops, iPhones, and iPads (where applicable).
- Fluency in written and spoken English and French.
- Strong organisational and problem-solving skills.
- Effective time and budget management skills.
- Ability to build and maintain effective working relationships with colleagues, managers, and clients.