Clinical Research Associate

The Clinical Research Associate assists in the management and coordination of clinical trials with specific emphasis on the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study.

Responsibilities

• Tracks study specific tasks and progress related to the management of the trial in support of the program manager
• Performs regulatory document review and approval for IP release and ethic and/or regulatory submission as required
• Assists in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings).
• Conducts monitor training for both internal and external monitors.
• Performs remote or on-site monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies.
• Drafts, reviews and approves relevant documents including (but not limited to) informed consent, site worksheets, pharmacy manual, central laboratory manual and clinical monitoring plan along with the Program manager's supervision
• Understands and implements processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes.
• Collaborates with data management to resolve queries.
• Facilitates investigator site payments, as applicable.
• Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation.
• Assists in evaluation of vendor performance during conduct of the study
• Assists the program manager with oversight of third party vendors performance (e.g., CROs, central laboratories)
• Reviews and approves monitoring reports for all types of site visits and contributes to review and/or approval of clinical study plans
• Contributes to regular review of protocol deviations when required as well as assisting with oversight of the Trial Master File (TMF) status
• Acquires a basic knowledge of the therapeutic area and product.
• Obtains a complete understanding of all trial-related documents and operational procedures.
• Gains exposure/participates in development of trial systems including but not limited to CRF development, CTMS, IVRS and central lab set-up, as well as other vendor selection processes.
• Maintains clinical trial management system (CTMS) information pertaining to the study.
• Assists with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation).
• Reviews and tracks study documents, including: project files both electronically and in the Trial Master File and Project Status Reports.
• Prepares accurate and complete meeting minutes for various meetings.
• Communicates and interacts with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy.
• Assists with effective and timely audit/inspection responses.
• Mentors junior team members
• Occasional travel involved

Who you are

• Advanced experience in all stages of clinical trial management from the Sponsor perspective, including site selection, initiation, monitoring, and closeout visits.
• Proven expertise in monitoring and verifying data quality and integrity. Proficiency in source data verification, query resolution, and data review procedures. Familiarity with electronic data capture (EDC) systems and other clinical trial management tools.
• Advanced experience working with and overseeing vendor CRAs and other vendor stakeholders
• Thorough knowledge of GCP principles and their application in clinical research.
• Strong verbal and written communication abilities to effectively liaise with study investigators, site staff, vendors, and other stakeholders. Capability to establish and maintain positive working relationships, resolve conflicts, and facilitate smooth communication channels.
• Typically requires 5-8 years' experience in clinical research including 3 years CRA experience within a pharmaceutical company
• Exceptional attention to detail, organizational abilities, and the capability to manage multiple priorities within strict timelines. Proficiency in maintaining accurate and comprehensive study documentation.
• Knowledge of regulatory submission processes, including ethics committee submissions, informed consent procedures, and regulatory inspections. Familiarity with adverse event reporting and safety monitoring requirements.
• Typically requires 8 years of experience in clinical research, including 2 years in a study management/leadership role within a pharmaceutical company.
• Bachelors degree in relevant scientific or medical discipline
• 8+ years' experience in clinical research including 5 years CRA experience within a pharmaceutical company desirable
• Master's degree or higher in relevant scientific or medical discipline desirable