Job Description

MW Partners is currently seeking a Clinical Research Associate to work for our client who is a global leader in the pharmaceutical industry.

Responsibilities and duties:

• Has a solid knowledge of the therapeutic area or a therapeutic background showing has adeptness to work in oncology and phase 1 studies
• Performs regulatory document review and monitors adherence to the regulatory document collection process.
• Able to write clinical monitoring plan, source documents and create other study tools when requested.
• Conducts monitoring/co-monitoring activities for interim site monitoring and closeout visits, in conformance to all relevant laws, regulations, guidelines, protocol, and internal SOPs/policies. Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required.
• Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
• Reconciles clinical supplies and drug accountability records at study sites.
• Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required.
• Reviews, clarifies, and obtains, data changes via query resolutions with site personnel.
• Collaborates with data management to resolve queries.
• Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities.
• Understands and implements processes for distribution and tracking of SAEs, safety documentation, and pregnancies. Monitors compliance of these processes.
• Facilitates investigator site payments, as applicable.
• Reviews/creates/tracks trial newsletters, memos, mass correspondence or other appropriate trial-related documentation.
• Obtains a complete understanding of all trial-related documents and operational procedures.
• Maintains clinical trial tracking information pertaining to the study e.g. Monitoring calendar, Monitoring reports, phone contacts.
• 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.
• 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.
• Prepares key reports and documents on progress of study for study manager.
• Tracks study specific tasks and progress of the trial.
• Reviews study and/or site specific ICF(s) for compliance with ICH/GCP and company SOPs.

Requirements:

• Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs.
• Good knowledge of therapeutic area assigned; oncology
• Preferred experience working with NCI
• Strong knowledge of ICH/GCP Guidelines and EDC process.
• Ability to establish rapport with site personnel/colleagues.
• Experience: 5+ years in clinical monitoring, in particular oncology therapeutic experience

For a confidential discussion or to find out more, contact Ritesh Sahu on 714-790-3621 / Itishree Mohanty on 909-200-3302 or apply now.

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