Primarily a training and development role, this position will support and observe clinical site monitoring services both inhouse and in the field whilst developing CRA skills and knowledge. This role will have exposure and training in all aspects of the clinical site monitoring services whilst providing monitoring and site management activities for full-service studies assessing for protocol, SOP, and regulatory compliance. Responsibilities include site management activities to help drive investigative site and patient recruitment, compliance, and oversight. Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities, assess data collection and (regulatory) document collection, perform remote and onsite activities for investigational sites including site contacts, qualification, initiation, monitoring and close out visits under supervision and/or independently and in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders.
Site Management
- Conducts and documents remote site contacts which could include remote site initiation, monitoring and close out visits. Documents activities per SOPs and study guidance.
- Conducts and documents onsite activities such as feasibility, qualification, initiation, monitoring and close out visits under supervision. Documents activities per SOPs and study guidance.
- Conduct remote data review of EDC, CTMS, RBM and other clinical systems to ensure alignment with SOPs, study guidelines and GCP best practices. Identify trends within and across study sites and escalate findings appropriately.
- Routinely reviews the site section of the TMF for accuracy, timeliness, and completeness. Requests new/updated documents from the site/primary assigned CRA, as required
- Support CRA II, Snr CRA and Lead CRA’s in day-to-day study management activities.
- Remotely monitor, resolve and/or facilitate resolution of queries arising out of regular and/or safety reviews, adverse events, and other data management activities throughout the trial.
- Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project life cycle.
- Supports preparation for audit and required follow-up actions.
Site Setup and Startup Support
- Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests, and forms, including investigational medicinal product, protocols, SOPs, CRFs, project documents, forms, and support tools.
- Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.
Training and Development
- Successfully complete CRA development track activities and milestones.
- Develop and demonstrate competencies required to fulfill the role of a CRA.
- Support and observe primary assigned CRAs at both onsite and remote visits.
- Support Lead CRA’s with remote site management activities.
- Participate on all study related activities, including but not limited to trainings, team meetings and provide any necessary updates to the study team.
Qualifications
- The successful candidate will possess a minimum of a college diploma/degree and 1-3 years related experience.
- SoCRA, CCRA and/or ACRP certification/designation is an asset.
- The successful candidate must exhibit the following skills: self-motivation with strong communication skills and a commitment to achieving positive results.
- Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.
- For one CRA position supporting Flemish sites in Belgium, Dutch language skills are required.
Working Conditions
