Mary Hayes
Los Angeles,California
Summary
Hardworking employee with customer service, multitasking, and time management abilities. Devoted to giving every customer a positive and memorable experience.
Dedicated Clinical Research Coordinator experienced in complying with study protocols, standard operating procedures and good clinical practices. Practiced problem-solver with strong attention to detail. Prepared to offer 20 years' experience in the field and take on a fast-paced position.
I am an APLHA and can relate to the "life of an ALPHA"who have A1AD. I have very good communication skills and love to help.
Im not looking to quit my current job. Im looking for additional job.
Overview
9
9
years of professional experience
Work History
Manager
Clinical Testing of Beverly Hills
Encino, CA
09.2014 - Current
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
- Monitored patient safety during clinical trials according to established guidelines.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Reviewed CRFs for completeness and accuracy before database entry.
- Assisted in the preparation of Institutional Review Board submissions for clinical trials.
- Reviewed medical records for accuracy of source documentation prior to database lock.
- Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Developed and maintained accurate and timely study databases.
- Developed case report forms for data collection at investigational sites.
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
- Performed patient assessments, collected and analyzed data, and prepared reports.
- Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
- Conducted quality assurance audits at research sites to ensure adherence to protocols, SOPs, regulations, guidelines.
- Organized, analyzed and modeled study data.
- Prepared informed consent forms for review by ethics committees.
- Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
- Coordinated investigator meetings, conference calls, and site initiation visits as needed.
- Assisted in preparing periodic reports summarizing progress of clinical studies.
- Provided training to study staff on protocol requirements and GCP regulations.
- Conducted screening interviews to determine eligibility of possible subjects.
- Took vital signs and collected medical histories as part of study protocols.
- Educated participants on studies and anticipated outcomes.
- Monitored subject enrollment and tracked dropout details.
- Gathered and reviewed study data.
- Placed orders for medications to be used in studies.
Education
GED -
James Monroe High School
North Hills, CA01-1994
Psychology
Los Angeles Pierce College
Winnetka, CASkills
- Performance Management
- Strategic Planning
- Operations Management
- Marketing
- Verbal and Written Communication
- Customer Relationship Management (CRM)
- Negotiation
- Staff Management
- Project Management
- Time Management
- Team Leadership
Timeline
Manager
Clinical Testing of Beverly Hills
09.2014 - Current
GED -
James Monroe High School
Psychology
Los Angeles Pierce College
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