Senior Clinical Research Associate - FSP - West Coast

Job Purpose:The Senior Clinical Research Associate (Sr. CRA) is responsible for the monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor, and close clinical sites in compliance with the Code of Federal Regulations (CFR) and International Council for Harmonization/Good Clinical Practice (ICH/GCP) Guidelines. This role may provide operational input to clinical study teams as directed.

Key Accountabilities:

Oversight of monitoring responsibilities:

• Applies Standard Operating Procedures (SOPs), Clinical MonitoringPlan (CMP), protocols, study   manuals, and other study materials as applicable• Helps identify and qualify potential investigators• Performs Pre-Study Site Visits• Assists with start-up activities, including essential document review andcollection as requested• Performs Site Initiation Visits• Provides initial and ongoing training to clinical investigators and othersite staff regarding the study protocol, procedures, documentation, aswell as regulatory requirements• Performs Interim Monitoring Visits for assigned studies:• Monitors site compliance with study protocol and GCP• Performs source data review and verifies adequacy of clinical datathrough comparison of case report forms to source documents perCMP• Ensures the site is entering data according to the Case Report Form(CRF) Completion Guidelines and meeting data entry and queryresolution deadlines• Performs drug accountability and ensure adequate drug supply

• Reviews research specimen sample documentation, storage, andprocessing, and ensures shipments are sent to central lab asrequired• Assists study team, as necessary, in resolving lab queries and otherissues• Collaborates with the drug safety group to ensure site compliancewith serious adverse event reporting requirements• Ensures adequacy of clinical supplies to the site• Collects and reviews site essential documents and ensures siteregulatory files are complete and accurate• Monitors site compliance with Institutional Review Board (IRB)policies/processes and ensures timely reporting, submissions, andapprovals• Tracks and reports progress of study, data monitoring, protocolvariations, issue resolution, and follow up compliance• Ensures site staff is appropriately trained and site responsibilities aredelegated to qualified staff• Performs Close Out visits as assigned• Prepares and completes visit trip reports, confirmation and follow upletters within timelines outlined in the CMP• Tracks, reports, and follows all action items to resolution• Maintains Clinical Trial Management System (CTMS) in a timely fashion,utilizing available reports and study tools• Works proactively with sites to address site issues and action items toobtain swift resolution and/or escalate to protocol lead/principalinvestigator (PL/PI) per CMP• Assists Data Management, as required• Provides co-monitoring support as requested or as necessary to developadditional skills• Contributes to the preparation and follow-up of on-site sponsored qualityaudits, as assigned• Completes routine administrative tasks in a timely manner• Discusses scientific, medical, and therapeutic area information• Attends staff meetings and trainings as required• May have opportunities to contribute to other clinical trial relatedactivities, including vendor management, data review, or other study- related activities• Contributes to department initiatives• May contribute to development and revision of study specific CMP andCRF Completion Guidelines and other study documents• May serve as a Subject Matter Expert (SME)

Collaborative relationships:

• Acts as liaison between the in-house team, vendors, and multiple clinicalsites• Works collaboratively with investigative sites to develop strong, long-term, working relationships• Contributes to department initiatives

Skills:• Excellent communication and organizational skillso Ability to discuss scientific, medical and therapeutic area information within small and largegroups   of medical professionalso Ability to proactively handle multiple tasks, manage a diverse range of functional activities,prioritize workload and solve problems simultaneously• Flexibility towards work assignments, learning, and travel• Highly responsive and proactive, a team player• Exercises independent judgment in developing methods, techniques and evaluation criteria for • obtaining solutions• Proficiency in written and spoken English - required• Proficiency in local languages (as applicable)• Other – able and willing to travel 55-75%. Travel requirements will vary depending on studyrequirements, site assignments, site remote monitoring capabilities, and geographical location

Knowledge and Experience:• Prior Oncology monitoring experience is required• Experience on global clinical trials is preferred• Previous experience with Electronic Data Capture (EDC), Electronic Trial Master File (eTMF) and CTMS systems.• Proficiency with Microsoft Office Products: Word, Excel, PowerPoint, SharePoint• Food and Drug Administration (FDA)/European Medicines Agency (EMEA) inspection readiness is preferred

Education:• Bachelor of Arts/Science (BA/BS), or equivalent, or relevant experience and training with at leastsix (6) years of pharmaceutical/biotech experience• Registered Nurse (RN) or health care professional preferred

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.