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| Job Title: |
CRA - In House - Late Phase |
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Job Location:
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Raleigh - North Carolina - USA |
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Job Category:
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Clinical Research Associate (CRA)
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Job description:
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A member of the Late Phase study implementation team with site management responsibilities. Responsible for the remote startup, management and closeout of sites participating in peri- and post-approval projects. Assigned projects may include Phase IV trials, patient registries, safety surveillance studies, health outcomes studies and other late phase product support programs.
1. In-House Site Management
• Serves as the primary contact and CRO representative for assigned sites on assigned studies.
• Assists with the identification and qualification of study sites.
• Negotiates study agreements and grant budgets, with guidance from project management team, as assigned.
• Ensures all assigned sites are trained on the study protocol, informed consent process, data collection requirements/data collection tools (e.g., EDC systems, IVR systems, etc.), SAE reporting requirements and patient-reported outcomes instruments, as applicable.
• Manages assigned sites via outbound telephone calls, web-based tools and other communications tools to ensure compliance with the protocol requirements, study procedures and ICH/GCP guidelines.
• Creates contact reports for each telephone session (outbound or inbound) with sites.
• Monitors site performance metrics and implements action plans for sites not meeting expectations.
• Supports patient enrollment at each assigned site via engagement of sites in study-wide patient recruitment programs or by working with Sr. CRA, Clinical Team Leader or Project Manager to develop a site-specific enrollment plan.
• Helps administer, track and reconcile grant payments for each assigned site.
• Maintains up-to-date site status information within the deployed clinical trial management system (CTMS).
• Conducts site closeout calls.
• Coordinates with CRAs making on-site monitoring visits to ensure efficient, productive visits.
2. Regulatory Document Collection and Processing
• Supports the collection of all necessary regulatory documents from assigned sites through either support of the functional services startup team or working directly with sites.
• Ensures all documents are collected and maintained according to applicable regulatory guidelines and CRO SOPs/WIs.
• Supports the submission of documents to institutional/independent review boards (IRBs) and/or Ethics Committees (ECs).
• Conducts audits of Trial Master File (TMF) according to study-specific management plans and applicable CRO SOPs/WIs.
3. Data Handling
• Promotes timely completion and submission of CRFs/eCRFs in accordance with study-specific clinical and data management plans.
• Reviews CRFs/eCRFs completed by sites and resolves queries and/or other identified data collection issues.
• Conducts data review calls with sites to assess successful completion of CRFs/eCRFs.
• Conducts remote source document verification via faxed/imaged copies of documents, as required.
• Performs review of clinical data listings, as required.
4. Communications
• Provides project management team with timely updates regarding site management and/or performance issues.
• Maintains effective communications with project team members, within as well as across functional units.
5. General
• Attends investigator meetings and/or off-site project team meetings, as required.
• Assists with the preparation and dissemination of meeting materials, as requested.
• Attends all project team meetings, group meetings and training programs as assigned by supervisor or as directed by Late Phase Services management team.
• Use software tools (e.g., ProjectTrend, Microsoft® Excel) to compile, monitor and report study metrics and prepare sponsor-requested reports.
OTHER RESPONSIBILITIES:
Performs other work-related duties as assigned.
Minimal travel may be required (up to 25%) (e.g., investigator meetings, project team meetings at sponsor, targeted on-site monitoring visits). |
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Skills:
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Employment type:
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Salary Range:
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Unspecified |
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| Other Information |
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Degree:
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Unspecified |
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Experience (year):
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Unspecified |
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Post Date:
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09/07/2008 |
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| Contact Information |
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Address:
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<a href="http://trials.in.ua">clinical research</a> 01033 - Ukraine |
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