Clinical Research Associate I

Summary

Join our team as a Training and Development Specialist to support clinical site monitoring services. You will observe in-house and field activities, developing CRA skills and knowledge. This role offers exposure to all aspects of clinical site monitoring, including monitoring and site management for full-service studies. Responsibilities include driving investigative site and patient recruitment, compliance, and oversight. You will conduct remote data reviews, support data query and closure, and participate in Risk Based Monitoring (RBM) activities. Onsite and remote activities will involve site contacts, qualification, initiation, monitoring, and close-out visits. You will collaborate with stakeholders and support audit preparation. This position is home-based with regular travel.

Requirements

• The successful candidate will possess a minimum of a college diploma/degree and 1-3 years related experience
• 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

Responsibilities

• Support and observe clinical site monitoring services both inhouse and in the field whilst developing CRA skills and knowledge
• Provide monitoring and site management activities for full-service studies assessing for protocol, SOP, and regulatory compliance
• 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
• 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
• 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
• 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

Preferred Qualifications

SoCRA, CCRA and/or ACRP certification/designation is an asset

Benefits

• Home-based
• Regular travel
• ���39,500 - €66,000 a year