Parexel FSP is looking for a Senior CRA in the MidWest!

Experience in CNS and /or Oncology preferred.

Job Purpose:

The Clinical Research Associate (CRA) will be a member of the Sponsor Monitoring team and provide monitoring expertise to individual clinical trials and/or programs

Key Accountabilities

Oversight of activities

Conduct and provide support for in-house and outsourced clinical site monitoring activities to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs) and study protocolsCollaborate with study teams during start-up/feasibility and conduct site identification and assessment tasks.Identify root causes and proactively escalate and resolve CRA and site performance issues through collaboration with stakeholdersProvide Monitoring expertise, mentoring and training to less experienced team members as requiredBuild positive working relationships and proactively seek feedback from site teams (e.g., Principal Investigators, Study Coordinators, Pharmacists, Site Administration)Partner with study teams and sites in conducting site outreach activities, including patient recruitment and retention strategiesProvide input and lead cross-functional teams through the process to determine monitoring strategy (risk-based monitoring) for studies as requiredUse regional knowledge to localize study processes and documents where possibleRepresent Monitoring at Investigator Meetings as requiredPerform other tasks as required

Collaborative relationships

Collaborates effectively with study teams and stakeholders to conduct site assessments, identify performance issues, and implement solutions that align with project goals and operational efficiency.

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 processes, ICH-GCPs and other applicable requirements

Skills:

Travel as required, to include domestic and internationalDemonstrates ability to work independently and in a team environmentProficiency with MS Office 365 (e.g., Word, Excel, PowerPoint, Outlook, SharePoint)Excellent oral and written communication skills and strong organizational abilitiesAbility to speak and understand multiple languages preferred

Knowledge and Experience:

Relevant clinical research experience (i.e., biotechnology, pharmaceutical, Contract Research Organization (CRO), medical device)Demonstrates working knowledge of GCP, ICH guidelines and FDA regulationsExperience in CNS and / or oncology preferredThe Clinical Research Associate can be staffed at multiple levelsClinical Research Associate I will have up to 2 years of relevant experience as assessed by the clientClinical Research Associate II will have a minimum of 2 years and up to 5 years of relevant experience as assessed by the clientSenior Clinical Research Associate requires 5 or more years of relevant experience as assessed by the client

Education:

BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred

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EEO Disclaimer

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