MARISOL R. CASTILLO
8773 Deblanc Place, Manassas, VA 20110
(571) 247 - 7088
A member of the monitoring team responsible for conducting study site monitoring visits to ensure the protection of study subjects and data accuracy. Ambitious and self disciplined industry professional experienced working with a cross functional environment. Able to combine resourcefulness and problem solving skills with clinical knowledge. Serves as a collaborative team player and leader, acting as a key resource to colleagues and allied health professionals. Knowledgeable with the laws, regulations, guidance and standard operating procedures and their application to regulated clinical research. Able to identify and differentiate the foundations and principles of clinical research ethics.
SpinalMotion, Inc. July 2011 – Present
Clinical Monitoring Coordinator
· Maintain accurate subject data with detailed documentation of all records including but not limited to: regulatory and safety, case report forms, study related communication, data logs to ensure data is complete and accurate.
· File and collate trial documentation and reports; archive study documentation and correspondence.
· Participate in improving initiatives, reviewing standard office procedures (SOP), and reviewing monitoring reports.
· Ensure the protection of study subjects by verifying that informed consent procedures and protocol requirements are adhered to according to applicable regulations and study office procedures (SOPs).
· Reviewed adverse events (AEs) to ensure subject data is correct and site has followed GCP, ICH guidelines and the established protocols of the Sponsor.
· In-house monitoring of study files, subject data and medical records.
· Assist with the review, collection and tracking of regulatory documents.
· Serve as a co-monitor by assisting other lead monitors during periodic monitoring visits.
· Working in collaboration with the Clinical Monitoring Director in designing and maintaining various tracking tools for collection and tracking of case report forms (CRFs) study visits, study queries from data management and error percentages.
· Tracking and performing quality control for various clinical data listings
· Liaison for clinical affairs team and data management
· Participated in quality improvement initiatives, reviewed SOP’s, and reviewed monitoring reports.
· Responsible for auditing subject data and site files for accuracy
SpinalMotion, Inc. April 2009 – July 2011
Clinical Monitoring Assistant
· Processed and tracked CRFs, data collection forms (DCFs) and queries from the data management department to resolve data discrepancies.
· Performed subject and site file reviews for consistency and accuracy of study data.
· Managed a monitoring database (data entry, tracking/trending, reporting & analysis) to provide a resource that is accessed electronically for organized study documents and data.
· Ensured that all invoices/reimbursements were correct, tracked and payments received.
· Participated in site monitoring, management and administration of clinical studies.
Bearcom November 2006 – February 2009
· Assigned to build a top-producing sales team and managed the sales department that led to company goals being achieved, such as an increase of sales by 12% in 6 months.
· Monitored the progress of issues within tracking systems, escalating problems to the technician(s) involved and/or management.
· Designed sales presentations and marketing material for customers and sales representatives to illustrate products that led to an increase of sales by 23% compared to the percentage of sales in the previous year.
· Controlled finances and payroll, including collecting dues, paying bills, generating invoices, maintaining petty cash accounts and tracking commission and bonuses.
· Worked with government clients to place orders, create purchase orders, order equipment, generate invoices and ensure orders are received.
National Mailing Systems October 2005 – November 2006
· Created and updated tracking reports and spreadsheets to ensure that equipment, such as postage machines, copiers, laptops, etc., were received at the correct location and orders were completed per company SOPs.
· Monitored the sales division by reviewing commission sheets for accuracy to maintain accurate sales numbers for each sales representative.
· Processed sales leads and forwarded any prospective leads to sales representatives.
· Created and updated sales presentations.
RSI Enterprises January 2003 – October 2005
· Communicated with Commercial Insurance, Managed Care, Medicare and Medicaid to research disputes, appeals and denials by negotiating payment to provide professional recovery services for various medical providers.
· Worked on early-out billing, recovery support, pre-collect and bad debt collections by contacting patients to advise and generate a solution for payment of medical claims.
Attorneys Healthcare Receivables September 1999 – January 2003
Workers Compensation Representative
· Investigated medical claims by contacting workers’ compensation companies or patients to verify claims information, such as the first report of injury to submit bills for processing.
· Submitted appeals for denied claims to insurance companies for reconsideration of payment, pre-authorization review, medical necessity approvals or additional payment.
Prince William County Courthouse September 1998 – August 1999
Assistant Deputy Clerk
· Entered restitution payments into a database to maintain accurate logs of payment information.
· Demonstrated negotiation skills when providing payers with solutions to resolving payment disputes.
· Research criminal backgrounds and traffic violations for attorneys, judges and other deputy clerks to provide additional support for criminal prosecution.
Leadership and Management:
· Implemented new work objectives that resulted in a multilateral achievement.
· Directed a staff, involving training, work flow, quality control, conflict resolution, and review processes.
· Problem solving experience and ability to help organizations operate more efficiently.
· Medical Devices
· Clinical Research/Studies
· Regulatory Support
· Insurance Billing
· Medical Terminology
· GCP/ICH auditing
· Project Management
Computer Literacy: MS Office, Outlook, Adobe Acrobat, PeopleSoft, JDE Edwards, NET time, Paycom, Citrix, FACS, Photoshop, Windows Live
WESTERN INTERNATIONAL UNIVERSITY, Phoenix, AZ, A.A. Business Administration, Management & Finance
GEORGE MASON UNIVERSITY, Fairfax, VA, B.S. Biology
(Expected completion December 2013)