Job Description

Position: Clinical Research Associate

Location: Durham, NC

Duration: 12 Months Contract

Job Description:

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, with supervision.

• Assist in the clinical trial management to ensure timelines and metrics are met and maintained throughout the study. Has knowledge of the therapeutic area and product. Participates in CRF development, IVRS set-up, central lab set-up, and other vendor processes set-up, with supervision Assists in the management of vendor performance during conduct of the study Assists in evaluation of vendor performance during conduct of the study. Oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance, with supervision.
• Contributes to the resolution of escalated issues from study centers, regulatory authorities and IRBs/Ecs with the support of the supervisor. Performs Sponsor Site Visits at selected sites to demonstrate oversight of the monitoring process and documenting the visits in the Sponsor Site Visit Report. Oversees study centers to ensure timely execution of the clinical studies, ensuring the well-being of the study subjects and the trial integrity with supervision. Reviews and tracks comments of monitoring reports generated by the vendor (ie. CRO) as part of Sponsor Oversight of Vendor Clinical Site Monitoring activities. Assist in verification of study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity, with supervision.
• With the support from the supervisor, may assist in the creation, review and tracking of study document Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation, with supervision. Tracks study specific tasks and progress of the trial. Gets more insight, maintains and updates clinical trial management system (CTMS) information pertaining to the study, when applicable. Assists on the TMF reviews and resolution of findings, internally or interacting with the CRO. Collaborates with the Clinical Quality Assurance department, with the support of the supervisor, to have Monitoring and TMF findings resolved on time as per SOP.
• 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 but not limited to: project files and Project Status Reports. Assists in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings). Supports the scheduling of internal team meetings, cooperating with defining the agenda and creating the meeting minutes, if needed. Provides support for the monitor training and contribute to resolve the issues they identified. Collaborates in ensuring that appropriate training is conducted for CRO staff, vendors, investigators, and study site staff on study requirements and internal SOPs (if applicable).
• "Is involved in the oversight of vendor clinical monitoring activities. Ensures that the clinical monitoring process is done in adherence to an international ethical and scientific quality standard to provide public assurance that the clinical data are credible. Assists in regulatory document review and approval for IP release. Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up. Assists in data management to resolve queries. Provides support in clinical product technical complaints and product recall as necessary.
• Provides support and information to the CTM staff regarding IP management, as needed. Assists in investigator site payments, as applicable, with supervision

Assists in providing with effective and timely audit/inspection responses.

Assist in the clinical trial management to ensure timelines and metrics are met and maintained throughout the study. Has knowledge of the therapeutic area and product. Participates in CRF development, IVRS set-up, central lab set-up, and other vendor processes set-up, with supervision Assists in the management of vendor performance during conduct of the study Assists in evaluation of vendor performance during conduct of the study. Oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance, with supervision.

Carries out in house clinical monitoring activities

• Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.
• Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine clinical trial protocol, GCP/ICH Guidelines and all applicable regulatory requirements compliance and in agreement with the Clinical Monitoring Plan for the study.
• Prepares telephone contact reports, confirmation letters, site visit reports (Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits), and follow-up letters to accurately and completely document site status and activities in agreement with the Clinical Monitoring Plan for the study.
• 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 8. Conducts monitor training.

Assist in the clinical trial management

• Tracks study specific tasks and progress of the trial.
• 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.
• Performs regulatory document review and approval for IP release.
• Monitors processes for distribution and tracking of SAE's, safety documentation, and pregnancies.
• 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 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.
• Assists in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings). Prepares accurate and complete meeting minutes for various meetings.

Regards,

Himani

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