US - Clinical Project Assistant - Contract
Location: Bridgewater New Jersey
Description: Novella Clinical is currently interviewing US - Clinical Project Assistant - Contract right now, this vacancy will be placed in New Jersey. For detail informations about this vacancy opportunity please give attention to these descriptions. Novella Clinical Resourcing is looking for a Clinical Project Assistant in the Bridgewater, NJ area for a 2 year Client contract plac! ement.
Primary Duties:
- Provides administrative assistance in documentation preparation, tracking, and filing of key information for the conduct of clinical research studies/projects.
- Ensures tasks associated with the set-up, implementation, and completion of all studies in accordance with appropriate Pharmaceutical Legislation and Directives, including confirming that all materials have been received by the site and all documents have been appropriately archived. Ensures the archival and storage of TMF documents has been done appropriately.
- Update Study Timelines In Electronic Clinical Trial Tool (e.g. CTMS).
- Assist with drafting a Site List by compiling a preliminary Site List and entering it into CTMS along with site metrics from previous studies, Principal Investigator's Regulatory Status and Regional Countries (locations).
- Assist in generation, compilation and distribution of essential regulatory documents! (e.g. CDA, 1572, CTA). Coordinates the critical documentation! process and tracks information received in-house; assists in ensuring adherence to applicable Client SOPs, and ICH/GCP guidelines; assist in identifying documentation non-compliance.
- Ensures updated regulatory documents (e.g. medical licenses, IRBs) are on file for each site.
- Assists in the tracking of essential documents progress and updating CTMS.
- Assist in Preparation for Site Initiation by sending materials to site.
- Compiles and distributes all site initiation (study start-up) packages (e.g. CRF booklets, enrollment logs, etc.); coordinates and distributes all regional (RCRA) study initiation packages; coordinates and distributes re-supplies as needed (e.g. study binders).
- Assist in the Processing of the Initial Drug Approval Package.
- Maintains patient recruitment logs across sites to ensure timely drug supplies at sites; distributes patient enrollment logs as defined in the monitoring plan; ensures patient enrollme! nt graphs are current.
- Assist with archival and storage of TMF Documents including assisting with a quarterly review; files documentation of clinical study related communication in TMF.
- Has worked within the Pharmaceutical or related Healthcare Industry, or has a degree, nursing qualification or CTA qualification
- Current awareness of appropriate EU Pharmaceutical legislations e.g. Clinical Trial and GCP Directives, ICH GCP guidelines
- Ability to travel up to 5%
- Basic understanding of Good Clinical Practices, ICH guidelines, PhRMA code, clinical research ethics, and patient privacy laws
- Basic understanding of clinical study costs
- Basic Knowledge of concepts of clinical research and drug development
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If you were eligible to this vacancy, plea! se email us your resume, with salary requirements and a resume to Novel! la Clinical.
If you interested on this vacancy just click on the Apply button, you will be redirected to the official website
This vacancy starts available on: Fri, 26 Jul 2013 01:23:29 GMT