Clinical Research Project
Resume:
Rafi Kiledjian
**** **** ****** **. # **-E Torrance, CA. 90501
Cell Phone: 818-***-****
Email: **********@*****.***
DEPARTMENT Clinical Monitoring, Clinical Division
LOCATION Home Based, Torrance, California, USA.
Employment Status
Employee
EDUCATION
2001 Medical Doctor
University of Carabobo
Valencia, Carabobo, Venezuela
PROFESSIONAL EXPERIENCE
Clinical Research Associate II
Oct 2016 to Present
Syneos Health, Clinical Division
Torrance, CA, USA
- Perform site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely.
- Oversee Site Start-Up projects as liaison, and consent form review.
- Follow standard processes for the collection, and processing of study site start-up documents, and site start-up information.
- Review completion of proper informed consent procedures.
- Ensure accurate data reporting via review of site source documents and medical records.
- Interpret data to identify protocol deviations and risks to subject safety/data integrity.
- Generate queries and manage resolutions with site personnel.
- Perform investigational product accountability as per the protocol and Study Monitoring Plan.
- Evaluate execution of study protocol at the site level. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team.
- Obtain, review, and process essential regulatory and administrative documents. Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance.
- Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan.
- Understand project scope, budgets, and timelines; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing variables to achieve goals / targets. Enter data into tracking systems as required.
- Act as primary liaison with study site personnel.
- Enter data into tracking systems as required.
- Participate in the identification and selection of investigators and clinical sites.
- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required.
- Provide clinical and technical support for project team as required.
- May interact with representatives of client affiliates as per project requirements.
- Collection and review of essential documents (1572, financial disclosures)understanding of FDA requirements pertaining to these documents.
- Maintain the tracking of project metrics in Site Start-Up tracker and provide status updates (Site Start-Up tracker, Site Identification Tracking Tools).
- Work with internal groups to meet deliverables (i.e. Patient Recruitment, Clinical Development, and Clinical Planning).
- Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook, Adobe Acrobat Professional and Microsoft Access. Clinical Research Associate I
Mar 2015 to Sep 2016
PRA Health Science
Torrance, CA, USA
- Initiate, monitor and close clinical trial sites in accordance with regulations.
- Perform site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely.
- Oversee Site Start-Up projects as liaison, and consent form review.
- Follow standard processes for the collection, and processing of study site start-up documents, and site start-up information.
- Collection and review of essential documents (1572, financial disclosures)understanding of FDA requirements pertaining to these documents.
- Review completion of proper informed consent procedures.
- Review Informed Consent obtained for all patients prior to study participation.
- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required.
- Determine the quality of the overall conduct of the study at the site.
- Verify that the subjects meet all the inclusion criteria to be enrolled in to the trial.
- Verify, and review that the spirometry were performed properly according of the protocol requirements.
- Review, verify, and report any abnormal laboratory results tests, which are performed routinely to the subjects during the entire trial.
- Verification that serious adverse event (SAE) reporting.
- Assess compliance for maintenance and administration of study drug at each on-site visit.
- To train site staff as necessary.
- Write and submit the Monitoring Visit Report.
- Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook, Adobe Acrobat Professional and Microsoft Access. Clinical Research Coordinator, Respiratory
Apr 2008 to Mar 2015
La BioMed
Torrance, CA, USA
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA Respiratory Department Responsible for the successful conduct of multiple ongoing clinical trials involving human subjects from project initiation through closeout. (Pre-study, initiation, routine, and close-out visits)
- Develop Case Report Forms for clinical trials, as needed
- Organize and present (e.g., study specific guidelines and procedures, case report forms, responsibilities) at staff meetings
- Provide leadership and training to Sub-Investigators, nursing staff and/or other support personnel
- Oversee and perform data entry, verification and storage for all research projects
- Submit Serious Adverse Event (SAE) reports
- Develop study documents
- Resolve queries of CRF data with Principal Investigator and study monitors
- Write Clinical Study Reports
- Train junior study coordinators, volunteers and nursing staff on internal procedures and Protocols
- Collection and processing of biological samples for laboratory analysis
- Perform ECG’s
- Perform PFT (Spirometry)
LICENSURE/CERTIFICATION
N/A
PROFESSIONAL MEMBERSHIPS
N/A
FOREIGN LANGUAGES
- English.
- Spanish.
- Armenian.
SUMMARY OF PROJECT EXPERIENCE
Therapeutic Area, Sub-Indication
and Drug Class Phase Job Title
Respiratory/COPD III CRA I
Respiratory/ Asthma III CRA I
Dermatology III CRA I
PUBLICATIONS/PRESENTATIONS
- Non-Invasive Assessment Of Skeletal Muscle Oxidative Capacity And Vasoreactivity In COPD By Near-Infrared Spectroscopy, Daniel T. Cannon, PhD, Non-Invasive Assessment Of Skeletal Muscle Oxidative Capacity and Vasoreactivity in COPD by Near-Infrared Spectroscopy, 2014.
- An Efficient New Method for Determining Oxygen Uptake Kinetics During Exercise: The Chirp Waveform, Michael A. Roman, DOI: 10.1164/ajrccm conference.2012.185.1_MeetingAbstracts.A2394, 2012.
- Sinusoidal high-intensity exercise does not elicit ventilatory limitation in chronic obstructive pulmonary disease, Janos Porszasz, ARTICLE in EXPERIMENTAL PHYSIOLOGY 98(6) · MAY 2013 with 18 READS, 2013.
Contact this candidate