When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel is seeking Senior Clinical Research Associates in Dallas TX, San Francisco CA, or Jacksonville FL! Phase I clinical trial monitoring experience is required and Oncology or Immunology experience is preferred.
Job Summary:
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 Monitoring Plan (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 and collection as requested
- Performs Site Initiation Visits
- Provides initial and ongoing training to clinical investigators and other site staff regarding the study protocol, procedures, documentation, as well 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 data through comparison of case report forms to source documents per CMP
- Ensures the site is entering data according to the Case Report Form (CRF) Completion Guidelines and meeting data entry and query resolution deadlines
- Performs drug accountability and ensure adequate drug supply
- Reviews research specimen sample documentation, storage, and processing, and ensures shipments are sent to central lab as required
- Assists study team, as necessary, in resolving lab queries and other issues
- Collaborates with the drug safety group to ensure site compliance with serious adverse event reporting requirements
- Ensures adequacy of clinical supplies to the site
- Collects and reviews site essential documents and ensures site regulatory files are complete and accurate
- Monitors site compliance with Institutional Review Board (IRB) policies/processes and ensures timely reporting, submissions, and approvals
- Tracks and reports progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance
- Ensures site staff is appropriately trained and site responsibilities are delegated to qualified staff
- Performs Close Out visits as assigned
- Prepares and completes visit trip reports, confirmation and follow up letters 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 to obtain swift resolution and/or escalate to protocol lead/principal investigator (PL/PI) per CMP
- Assists Data Management, as required
- Provides co-monitoring support as requested or as necessary to develop additional skills
- Contributes to the preparation and follow-up of on-site sponsored quality audits, 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 related activities, including vendor management, data review, or other study-related activities
- Contributes to department initiatives
- May contribute to development and revision of study specific CMP and CRF Completion Guidelines and other study documents
- May serve as a Subject Matter Expert (SME)
Collaborative Relationships
- Reviews research specimen sample documentation, storage, and processing, and ensures shipments are sent to central lab as required
- Works collaboratively with investigative sites to develop strong, long-term, working relationships
- Contributes to department initiatives
Compliance with Parexel Standards
- Complies with required training curriculum.
- Completes timesheets accurately as required.
- Submits expense reports as required.
- Updates CV as required.
- Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.
Skills:
- Excellent communication and organizational skills
- Ability to discuss scientific, medical and therapeutic area information within small and large groups of medical professionals
- 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 study requirements, site assignments, site remote monitoring capabilities, and geographical location
Knowledge and Experience:
- 4+ years of prior CRA monitoring experience in a CRO or Pharma organization is required
- Prior oncology/immunology experience is preferred
- 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 least six (6) years of pharmaceutical/biotech experience
- Registered Nurse (RN) or health care professional 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 US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.