Clinical Research Associate

Clinical Research Associate

Durham, NC

04 Months

Summary: Assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of interim and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study. This is a contract traveling CRA position if necessary.

Primary responsibilities for role:

• 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.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Knowledge, Skills and Abilities:

• 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