TRAINING

BRCR Global Staff should be trained to understand and perform all tasks related to their job neatly.

Training covers all aspects of a study operation, including patient screening and registration, and completion, submission and correction of all data forms.

Each Director, as defined in the organizational chart, must be responsible for communicating objectives in a timely and effective manner so assigned goals can be achieved by each BRCR Global associate
All BRCR Global associates must sign confidentiality agreements.

BRCR GLOBAL QA department is responsible for the administration of its training system which encompasses several categories of training to ensure that BRCR Global members have the level of skill and knowledge necessary and required to perform their job responsibilities.

Site personnel are trained to run on-line reports on the status of queries, and can view cumulative data summaries for each or all of their patients over time.

We help our staff members build essential skills they use in the work they do every day.


THEORICAL REVIEW
GCP/ ICH GUIDELINES review, PROTOCOL review, internal SOP review


HANDS-ON SCENARIOS
Enrollment scenarios, regulatory packets completion, source templates creation, IP logs completion, filing, subject visit scenarios.


WEEKLY TRAINING SESSIONS
Staff meeting including protocol specific training.


SOP CREATION
New SOP documents, amendments to previous SOPs based on FDA inspections/ Sponsor audits/monitoring visits reports.


PATIENT REGISTRATION

Boca Raton Clinical Research follows HIPAA Guidelines and maintains patient confidentiality. Patient registration, medical history, family history and trial participation is stored in our patient database and is never shared or sold