Senior Clinical Research Associate

PXL FSP is hiring a Senior CRA in Canada! This is a remote role with travel in the Montreal and Toronto area.

Job Purpose:The Senior Clinical Research Associate is responsible for the following:• Act as the primary site contact and site manager throughout all phases of aclinical research study, taking overall responsibility of allocated sites.

Key Accountabilities:AccountabilitySupporting Activities may include but not limited to the following:

Site ManagementResponsibilities• Develops strong site relationships and ensurescontinuity of site relationships through all phases of thetrial• Performs clinical study site management/monitoring activities incompliance with Good Clinical Practice (GCP) / InternationalCouncil for Harmonization (ICH), Sponsor SOPs, Local Laws &Regulations, Protocol, Site Monitoring Plan, and associateddocuments• Gains an in-depth understanding of the study protocol and relatedprocedures• Coordinates & manages various tasks in collaboration with other sponsorroles to achieve Site Ready• Participates & provides inputs on site selection and validation activities.• Performs remote and on-site monitoring & oversight activities usingvarious tools to ensureo Data generated at site are complete, accurate and unbiasedo Subjects’ right, safety and well-being are protected• Conducts site visits including but not limited to validation visits,initiation visits, monitoring visits, closeout visits and recordsclear, comprehensive, and accurate visit & non-visit contactreports appropriately in a timely manner• Collects, reviews, and monitors required regulatorydocumentation for study start-up, studymaintenance and study close-out• Communicates with Investigators and site staff on issuesrelated to protocol conduct, recruitment, retention,protocol deviations, regulatory documentation, siteaudits/inspections and overall site performance• Identifies, assesses, and resolves site performance, quality orcompliance problems and escalates per defined CRAEscalation Pathway as appropriate in collaboration withClinical Research Manager and Partner Line Manager• Manages and maintains information and documentation inClinical Trial Management System, Electronic Trial Master Fileand various other systems as appropriate and per timelines

Team Development and Support• Contributes strongly to CRA team knowledge by acting asprocess Subject Matter Expert, sharing best practices, makingrecommendations for continuous improvement, and providingtraining as appropriate/required• Supports and/or leads audits/inspection activities as needed• Mentors / buddies junior CRAs on process/study requirements• Contributes to initiatives and projects adding value to the business• Performs co-monitoring as appropriate compliance with ParexelStandards• Comply with required training curriculum• Complete timesheets accurately as required• Submit expense reports as required• Update CV as required• Maintain a working knowledge of and complies with Parexel/Clientprocesses, ICH-GCPs and other applicable requirements

Skills:• Fluent in local languages and English (verbal and written) and excellentcommunication skills, including the ability to understand and present technicalinformation effectively• Excellent understanding and working knowledge of clinical research, phases ofclinical trials, current GCP / ICH and country clinical research law and guidelines• Hands on knowledge of Good Documentation Practices• Excellent understanding of Global, Country/Regional Clinical ResearchGuidelines and ability to work within these guidelines• Demonstrated ability to mentor/lead• Proven skills in Site Management including independent management of siteperformance and patient recruitment• Demonstrated high level of monitoring skill with independent professional judgement• Good IT skills (Use of MS office, use of various clinical IT applications oncomputer, tablet and mobile devices) and ability to adapt to new ITapplications on various devices• Ability to understand and analyze data/metrics and act appropriately• Experience with conducting site motivational visit designed to boost site enrollment• Capable of managing complex issues, works in a solution-oriented mannerParexel International• Performs root cause analysis and implements preventative and corrective action• Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate• Effective time management, organizational and interpersonal skills, conflictmanagement, problem solving skills• Able to work highly independently across multiple protocols, sites, and therapy areas• High sense of accountability / urgency• Ability to set priorities and handle multiple tasks simultaneously in a changing environment• Works effectively in a matrix multicultural environment; ability to establish andmaintain culturally sensitive working relationships• Demonstrates commitment to customer focus• Works with high quality and compliance mindset• Positive mindset, growth mindset, capable of working independently and being self-driven• Demonstrates and projects professional demeanor and communication consistentwith organizational policies and practices• Ability to travel domestically and internationally approximately 65%-75% of working time• Expected travelling ~2-3 days/week• Current driver’s license required

Knowledge and Experience:• Minimum 4 years of direct site management (monitoring) experience in bio/pharma/CRONote: Specific monitoring or therapeutic experience/requirements may vary depending on the Country or study needs

Education:• Bachelor’s degree preferred with a strong emphasis in science and /or biology