Management Clinical Research

Cynthia Asante

**** *** **** ****., #*** Sherman Oaks, C A 9 1403 (8 1 8) 648 – 6828 ************@***.***

SUMMARY OF QUALIFICATION

• Quality conscious Clinical Research Associate with over 3+ years' experience in Phase I IV Studies.

• Responsibilities have included site initiation, monitoring, source document verification, and drug safety.

• Knowledge of Study Protocol, worked in accordance with Federal Regulations, Good Clinical Practices, ICH

Guidelines and Standard Operating Procedures and Guidance Documents

• EDC experience with Medidata RAVE and Datalabs.

• Management of Clinical Trials, formulating source documents, IRB protocol submission IRB Phases and IND

Safety Reporting.

Therapeutic Experience

Therapeutic Area Indication Phase Time Length

Infectious Diseases II 1yr 5months

Hepatitis

Neurology II 10 Months

Chronic Pain

Psychiatry III 1yr 6 months

Anxiety/Depression

Respiratory III 2yr 1 months

Mod/Severe Asthma

Pediatric III 2 yr 8 months

Pain Management

EDUCATION HIGHLIGHTS AND CREDENTIALS

University Of Phoenix: Masters of Business Administration 2006

Cleveland State University: Bachelors of Arts and in Liberal Arts and Anthropology 1996

Minor in Biology GPA –3.8/ 4.0

PROFESSIONAL EXPERINCE

Clinical Research Associate II Oct. 2011 – Present

Anchen Pharmaceutical Inc., Irvine, CA

• Phase I IV Experienced

• Participated in the management of assigned clinical trials.

• Responsibilities included, abstracting, assembling and organizing research data while monitoring the clinical

course of patients entered onto research protocol

• Participated in protocol development with a particular focus on data collection

• Prepared report on individual patients or a study population in response to investigator requests and prepared

adverse event report

• Conducted Pre study, Initiation, interim and Closeout Visits

• Implement and monitor clinical trials to ensure sponsor and investigator obligations are being met and are

compliant with applicable local regulatory requirements and ICH GCP guidelines

Clinical Research Associate I Sept. 2010 – Oct. 2011

2

Anchen Pharmaceutical Inc., Irvine, CA

• Monitored clinical sites including Site Qualification, Site Initiation, Interim Monitoring, and Closeout Visits.

• Submitted research data in a timely manner to external affiliates, agencies, sponsors and Institutional Review

Boards

• Performed source document verification, retrieved case report forms (CFRs) and performed query resolution in a

timely manner and oversaw drug accountability and safety at investigation sites

• Created Informed Consent Forms and other IRB approved Subject Forms; coordinated translation of ICF and other

Subject Forms for sites

• Prepared for and participated in audits of assigned studies and assisted with the preparation of annual protocol

renewal request and, or termination report

• Provide monitors clinical regular site status information to team members, trial management, and updates trial

management tools

• Complete monitoring activity documents as required by SOPs or other contractual obligations

Clinical Research Associate I Oct. 2009 Sept. 2010

Aptuit

• Work closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues

• Escalate site and trial related issues per SOPs, until identified issues are resolved or closed and performs essential

document site file reconciliation; performs source document verification and query resolution

• Assess the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site

personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites

• Review and verify the accuracy of clinical trial data collected, either onsite or remotely

• Verify Serious Adverse Event (SAE) reporting according to trial specifications and ICH GCP guidelines

• Communicate with investigative sites, Update applicable tracking systems, Ensure all required training is

completed and documented, Serve as observation visit leader, Facilitate audit and audit resolution

• Assess IP accountability, dispensation, and compliance at the investigative sites

Licenses and Skill

• ACRP: Association Of Clinical Research Professionals (2009)

• The National Institute of Health (NIH): Certification in “Protecting Human Research Participants”

•

Computer Experience

• Word, Excel, Outlook, Rave, Datalabs, UBC and EDC

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