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• To Register by FAX: download form (PDF)

• All-Inclusive, CRUISE with 2days training and
• Beach RESORT in Fort Lauderdale, Florida

Contact Us :

Tel:  +954-957-3957;
Fax: +954-366-6011;

E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

• Organize the steps of a Clinical Trial. Site placement, Initiation, Monitoring, Close-up. The RN will be able to organize those meetings coordinating the investigator and other medical and administrative personnel to attend.

• Protocol assessments. The RN will be able to interpret all the requirements of the protocol from the point of view of assessments, testing and patient compliance and investigational product accountability

• Subject selection. Identify potential subjects from review of existing protected health information per Inclusion/Exclusion criteria. Patient confidentiality

• Screening and Recruitment. Assist Investigator with screening and recruitment of patients.

• Informed consent process The RN will manage the informed consent process with discussion of treatment and patient management as well as other therapeutic alternatives.

• Organization and patient management. The RN will be able to plan/coordinate patient schedule for study procedures, return visits and study treatment schedules. Perform assessments at visits and monitor for adverse events. Educate patients about study procedures to be performed, visit schedule, what to report in between and during visits and potential side effects to expect, by the use of diaries as appropriate. Phone contacts

• Investigators Clinical Trials Files. The Coordinator will organize file handling to ensure that documentation in the medical record is complete and on schedule. Also will develop the ability to transcribe data into CRF (paper forms and electronic forms) and databases. Will keep written documentation of every step of the clinical research process. Handling of protocol deviations or violations (by documentation in writing with appropriate follow-up). Collection of all documentation required to initiate a clinical study.

• Serious Adverse Event Management. Obtain all internal and external information required to complete, report and follow up of Serious Adverse Events per regulatory, study sponsor and IRB requirements.

• Investigational Product Accountability. Ensure appropriate drug orders are written, infused and appropriate testing; examination; procedures are performed during designated patient study visits.

• Communications. Be a major liaison with pharmaceutical companies and regulatory bodies. Schedule visits from the sponsor. Prepare and respond to study monitors and sponsors and/or internal, external and FDA/HC audits.

• Coordination activities. Coordinate patient visits/assessments and sponsors visit with investigators availability. Coordinate reams of paperwork, data management, and suddenly changing priorities and deadlines.

•  Clinical Research

•  Product Development

•  Consultants

•  Project Management

•  Documentation and Medical Writing

•  Quality Assurance

•  Others who interact together to launch a product

•  Regulatory Affairs

•  Product Submission

•  Training

• Airfare

• Transportation to/from the airport

• Parking, tips...

• **Hotel accomodation: (Pelican Beach resort is completely non-smoking)

• Tax is not included, please add 6% to the price of the course.