- leadership, organizational, oral, written communication, interpersonal, analytical, and problem resolution skills. Thrive in both independent and collaborative work environments.
- Skilled in building long-term relationships with all levels of hospital staff and pharmaceutical and medical equipment representatives. Achieved significant results related to promoting organizational growth and staff development, securing necessary industry-related designations, and increasing overall patient volume.
- Strong knowledge of Windows, Word and Excel based operating systems, software applications.
- Motivated and ambitious with excellent interpersonal communication, relationship management, and presentation skills.
- R&D Lab Experience.
- Have excellent analytical as well as mechanical features.
- Have ability in taking up new theories as well as responsibilities.
- Have in depth knowledge in the respective subject.
- Quick study, with an ability to easily grasp and put into application new ideas, concepts, methods and technologies. Dedicated, innovative and self-motivated team player and builder.
- Databases: MS Access.
- Operating Systems: Windows (NT, 2000, XP, 98, 95, Vista).
- Others: Word, Excel, PowerPoint, Outlook, SPSS.
- Knowledge in the programming languages: C, C++, visual C++
ABC Inc. Any Town, NY
Clinical Research Associate (05/07 to Current)
- Managed several study protocols at one time.
- Screened potential subjects for protocol eligibility. Presented trial concepts and details to the subjects, participated in the informed consent process, and enrolled subjects into the studies.
- Responsible for accurate and timely data collection, documentation, entry, and reporting.
- Identified quality and performance improvement opportunities and collaborated with staff in the
- Development of action plans to improve quality.
- Served as the primary liaison between investigators, clinical staff, and research subjects.
- Provided instruction and management to staff of lower grades and train research staff.
- Assisted in the development of protocols and maintenance of budgets.
- Prepared and presented research data at scientific conferences.
- Provided scientific support for clinical research studies and assisted in grant writing and preparation of manuscripts.
XYZ Corp. Any Town, NY
Clinical Research Associate (03/2002 to 04/2007)
- Responsible for ensuring that clinical investigative sites: protect the subjects rights and safety, adhere to protocols, Standard Operating Procedures, ICH guidelines, Good Clinical Practices and FDA guidelines.
- Conduct Site Initiation, Routine monitoring and Site Close-Out Visits.
- Review regulatory documents, investigational product accountability, Case Report Form source document verification and prepare site visit reports.
- Assist in collecting data management queries and data clarification forms.
- Investigational sites first line of support for study related activities such as IP shipment, central and local Institutional Review Board activities, and Code of Federal Regulations questions.
BCD Inc. Any Town, NY
Clinical Research Associate (01/2000 to 02/2002)
- Conducted evaluation, initiation, and routine monitoring and close out visits at each assigned study site.
- Instructed investigator site staff in their responsibilities and ensures compliance with GCP and ICH guidelines.
- Worked in conjunction with the in-house project teams to ensure that sites have adequate study drugs and supplies.
- Designed and created blueprint for Drug Compliance and Pharmacy Accountability to track study subjects compliance to medications for study site and clinical monitors.
- Identified and evaluated potential investigation sites, documenting and routing appropriately concerned departments.
- Tracked and monitored enrollment at the sites, initiating additional recruitment strategies as required.
- Submitted monitoring reports per SOP.
- Reviewed investigator files to verify that the site complies with FDA regulations and internal SOPs.
- Reviewed study files and update tracking information reported for key study forms.
- Determined availability and completeness of study files and identifies deficiencies.
- Assists the data management groups and the project team in the processing of all clinical data by ensuring the timely collection of other aspects of job-related responsibilities data and query resolution.
- Worked as an integral team member with respect to quality, integrity, timeliness, and cost effectiveness when monitoring, and in all.
- Input and maintained electronic site management systems.
- Assisted project teams by ensuring that all data is collected and submitted within appropriate time lines and communicates these time lines to the investigational sites.
- Managed time effectively in order to fulfill requirement to meet all time lines, in both therapeutic work and submission of administrative documents.
- Assisted investigational site in the management of timely query resolution.
- Motivated site staff to reach goals. Develops successful, professional rapport with site staff.
- Assisted in updating study trackers and ensures accuracy against clinical database.
- Effectively interacted with team members to drive project goals.
- in Business Administration in 2002 from the University of Texas, Austin.
- Bachelors in Pharmacy in 1997 from University of California, Santa Barbara
- Clinical Research Training from A1 Institute at New York, NY
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