Regulatory Document Coordinato
Medfocus.com - Florida

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* Coordinate activities as related to the conduct of all phases of pharmaceutical, biotechnology and medical device clinical trials
* Collection and maintenance of regulatory documents from investigative sites
* Review and approval of site regulatory documents, including financial disclosure forms, Form 1572’s/Investigator Agreement, CVs and medical licenses, etc. for completion, accuracy and compliance with HCRI, FDA and GCP requirements
* Creation and distribution of regulatory packets and Investigator Binders to investigative sites
* Develop and maintain databases for tracking of regulatory documents, work flow process and other essential trial related documents
* Communicate with sites on regulatory document needs, document insufficiencies and document expirations
* Coordinate and distribute Investigator payments and Site/IRB invoices
* Review Informed Consent forms and other study specific forms as first reviewer
* Generate and maintain study and site specific trial master files
* Organize and preparation of trial related materials and presentations for Investigator and/or coordinator meetings
* Work with in-house study team and Sponsor in identifying and screening qualifications of appropriate investigative sites
* Help to maintain a site/investigator selection system/process
* Provide centralized site support, communication and coordination to assure accurate and timely completion of all contracted activities
* Provide ongoing site management support through project completion
* Facilitate general communication among the research centers, HCRI project teams, sponsors, site monitors and vendors relative to the responsibilities itemized above

About this company
MedFocus provides clinical trial contract staff and outsourcing services to pharmaceutical, biotechnology, and medical device companies....