Senior Clinical Research Associate FSP - Oncology - Northern California

Parexel is seeking Senior Clinical Research Associates in Northern California! Phase I clinical trial monitoring experience is required and Oncology 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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