Elizabeta Kameric

• Assisted with subject recruitment procedures and Maintained accurate and timely research records while maintaining subject confidentiality
• Performed task management and additional administrative responsibilities and identify any problems with protocol compliance
• Maintained all Regulatory Documents Protocol, IRB Site Application, Confidentiality Agreements, CV's of PI's and Sub-PI's, Medical Licenses, Informed Consent Forms, FDA form 1572
• Maintained site files and study documentation and status reports and document quality control
• Collected and maintain file of regulatory documents, study documentation and communication for each study
• Assisted dispense study medication following protocol requirements
• Obtained informed consent for study participation
• Provided laboratory results to Principal Investigator for review, filed results in subjects binder
• Ensured completing all pending items from screening review 100%
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Attended Sponsor Investigator Meetings, and Site Monitoring Visits when applicable.
• Dispose/destroy expired drugs and retention study drugs.
• Review study protocols for specific study requirements prior to preparation of pharmacy documents and drug dispensing.
  

• Review study protocol and participate in protocol training meeting prior to performing any study related activities
• Perform ECG and Vital Signs
• Perform drug/cotinine screen and alcohol test as well as urine pregnancy test
• Obtain body measurements, including height and body weight, and calculate Body Mass Index (BMI)
• Proper collecting, handling, and processing of PK samples
• Process and ship lab samples
• Assist in drug administration by performing hand and mouth check
• Perform data review of source and/or other related documents as required

• Assisted patients including answering phones and responding to customer inquiries.
• Assisted laboratory staff in daily operation of lab by collecting, labeling, processing and preserving blood, urine and other specimens according to established laboratory procedures.
• Entered lab orders in appropriate laboratory and electronic medical record system.

● Kept operations running smoothly and solved diverse problems by coordinating with staff, management and internal departments

• Obtained variety of blood samples through venipuncture 200 times per day or butterfly needles, and straight needles
• Coordinated workflow based on stat, schedule or procedure needs
• Developed and arranged continuing education opportunities for all staff to increase knowledge and skills
• Regularly evaluated employee performance, provided feedback and assisted, coached and disciplined staff as needed
• Adhered to facility and legal requirements for standards of care and operations
• Established team schedules that met all coverage needs

• Processed biological samples as required to conduct a clinical study
• Demonstrated proficiency in clinical procedures such as but not limited to: study check-in procedures, subject and belongings search, mouth check, blood sample collection and urine collection, sample processing and storage, according to the study protocol and SOP requirements
• Properly completed documentation of clinical activities according to GCP,SOP guidelines, and FDA regulations
• Monitor clinical activities (subject entrance, subject exit)