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| Job Title: |
Research Associate |
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Job Location:
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Raleigh - North Carolina - USA |
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Job Category:
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Project Management
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Job description:
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Acts as support to the Project Manager and is responsible for all Research Associate tasks on assigned projects and activities, assuring adherence to Good Clinical Practices, regulatory guidelines, and study procedures including the following:
COMMUNICATION
Maintains timely and effective communication among team members and site staff.
Keeps Project Leadership and CRAs fully appraised of site and study status.
Contacts site staff as needed for critical information.
REGULATORY DOCUMENTATION
Assures compliance with CFR, state regulations, ICH and GCP guidelines, and INC Research and sponsor SOPs and Work Instructions (WI).
Maintains current regulatory documentation according to Essential Regulatory Document Guidelines (ERDG) and Trial Master File (TMF) Plan.
Reviews and submits Essential Regulatory Documents for second review.
Prepares and disseminates Investigator Regulatory Binder.
MONITORING & DATA HANDLING (performs as needed)
Assists with in-house case report form (CRF) review as needed.
Participates in Quick Start camp as requested.
Assists in data query process.
Responds to TMF audit findings.
REPORTING AND TRACKING
Utilizes ProjecTrend to track and process clinical trial information, e.g., regulatory documents, enrollment, SAE/ AEs, protocol deviations, supplies, IRB re-approvals.
Communicates key study performance indicators to PM/LCRA.
Coordinates shipment of study material.
Tracks Investigator payments/ milestones.
Reports and tracks outstanding regulatory documentation for CRAs.
Tracks CRF submission timelines.
Participates in generation of monthly status reports for customer.
ADMINISTRATIVE
1. Assists in preparation for and attends investigator’s meetings.
2. Prepares and maintains Study Reference Manual and site reference tools.
3. Assists in informed consent form (ICF) development as needed.
4. Drafts and prepares documents for mass dissemination.
5. Arranges for receipt of administrative and regulatory documents.
6. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project Communication, Monitoring and / or Training Plans.
7. Supports clinical monitoring as needed, traveling. |
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Skills:
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Requires a B.A. / B.S. in the science/health care field, nursing degree, or equivalent degree, or equivalent related experience. Preferably a minimum of one year clinical or research experience. Advanced Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail skills required. Database experience preferred. Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. Requires strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment. Uses effective tools and strategies in written and verbal communication.
Please include salary requirements |
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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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Bachelors |
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Experience (year):
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1 |
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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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