Clinical Research Associate - All locations- FSP

Oncology experience preferred - but multi-specialty also encouraged to apply All US locations - West and Central preferred The Clinical Research Associate is responsible for the following: Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites Job Description Key Accountabilities: Site Management Responsibilities Develops strong site relationships and ensures continuity of site relationships through all phases of the trialPerforms clinical study site management/monitoring activities in compliance with International Conference on Harmonization / Good Clinical Practices, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated DocumentsGains an in-depth understanding of the study protocol and related proceduresCoordinates and manages various tasks in collaboration with other sponsor roles to achieve Site ReadyParticipates and provides inputs on site selection and validation activitiesPerforms remote and on-site monitoring & oversight activities using various tools to ensure:Data generated at site are complete, accurate and unbiasedSubjects’ right, safety and well-being are protectedConducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely mannerCollects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-outCommunicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performanceIdentifies, assesses, and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with Clinical Research Manager and Partner Line ManagerManages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines Team Development and Support Contributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/requiredSupports and/or leads audits/inspection activities as neededPerforms co-monitoring visits where appropriate Compliance with Parexel Standards Complies with required training curriculumCompletes timesheets accurately as requiredSubmits expense reports as requiredUpdates CV as requiredMaintains a working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements Skills Fluent in local languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectivelyGood understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelinesGood understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelinesHands on knowledge of Good Documentation PracticesProven skills in Site Management including management of site performance and patient recruitmentDemonstrated high level of monitoring skill with independent professional judgementGood IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devicesAbility to understand and analyze data/metrics and act appropriatelyCapable of managing complex issues, working solution – oriented mannerPerforms root cause analysis and implements preventative and corrective actionEffective time management, organizational and interpersonal skills, conflict management, problem solving skillsDemonstrated high level of monitoring skill with independent professional judgementAble to work highly independently across multiple protocols, sites, and therapy areasHigh 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 and maintain culturally sensitive working relationships.Demonstrates commitment to Customer focusWorks with high quality and compliance mindsetPositive mindset, growth mindset, capable of working independently and being self-drivenDemonstrates and projects professional demeanor and communication consistent with organizational policies and practicesAbility to travel domestically and internationally approximately 65%-75% of working timeExpected travelling ~2-3 days/weekCurrent driver’s license required Knowledge and Experience Minimum 2 years of direct site monitoring experience in bio/pharma/CRO Note: Specific monitoring and therapeutic area 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

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• LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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