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yyyyyy x. yyyyyy 0000 xxxxxx xxxx , xxxx , xxxxx 00000
xxx-xxx-xxxx
objective
results-driven leader with expertise in clinical research and study site management eager to contribute talents toward actively supporting a progressive organization in optimizing performance as a project manager.
career profile
ø over eight years of clinical research and medical drug-verification trial experience.
ø bachelor of arts in psychology and currently pursuing pmp certification.
ø expertise in research oversight, drug trial management and patient welfare.
ø proven background in study coordination, documentation and data collection.
ø outstanding skills in direction of clinical, ethical and supervisory procedures.
ø knowledgeable in administrative leadership, quality and management.
ø exceptional communications and interpersonal abilities.
ø adept in developing operational protocols and standards.
ø demonstrated coordination abilities.
ø self-motivated, self-directed multi-tasker with excellent detail orientation.
professional experience
pharmaceutical product development, austin, tx 2009 - present
principal clinical research associate (cra)
monitor clinical trials and ensure compliance with good clinical practice and investigator integrity rules.
responsible for site management, documentation, monitoring, data analysis and training of new cras.
maintain positive relations with principal investigators, verify document information and data capture.
quintiles, austin, tx 2005 - 2009
senior clinical research associate
developed and presented trial protocols to committee, and designed case record form documents.
coordinated with ethics committee, managed regulatory drug approvals and assessed test facilities.
established study centers, coordinated with doctors during trials and trained staff to proper standards.
monitored clinical trials, verified crf data, drafted visit reports and accounted for unused trial samples.
closed centers upon trial completion, analyzed results with doctors and prepared final study reports.
cedra clinical research, city, state 2003 - 2005
clinical research coordinator
implemented protocols, coordinated with peers and supervisors and managed source document qc.
ensured test subject suitability, developed report documentation and notified irb of test deviations.
worked with assistant coordinator to complete crfs, resolved sponsor queries and recruited subjects.
point person for study site, maintained positive relations with sponsors and prepared all study reports.
trained new staff members and assisted in development of standard best practices and compliance.
professional quality research, city, state 2002 - 2003
research associate
recruited test subjects for study and collected screening data on vital statistics, height, weight, ecgs, etc.
st. david s hospital, city, state year - year
research associate
please list 2-3 specific duties, responsibilities or accomplishments of this position here.
education
texas state university, san marcos, tx
bachelor of arts, psychology, 2003
ppd foundations gcp training, 2009
quintiles, core clinical training, 2005
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