Marisol CastilloWashington D.C. Metro Area

Company Name

CRA Solutions (Biotechnology)

Position Held

Clinical Project Coordinator (Consultant)

Dates

0000 - Present

Details

• Coordinate with Clinical, Marketing, Data and Operations management to identify goals and scope of clinical study projects. Manage and execute the overall project scope, protocol and timelines.
• Monitor study activities to ensure compliance with protocols and with all relevant local, Federal, and state regulatory and institutional polices.
• Cooperate with compliance and monitoring efforts related to sponsored program administration and report instances of noncompliance to the appropriate office.
• Coordinate and facilitate monitoring and auditing visits.
• Collect data as required by the protocol and ensure timely completion of Case Report Forms and maintain study timelines.
• Complete study documentation and maintain study files in accordance with sponsor requirements, policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms
• Maintain effective and ongoing communication with sponsor, research participants and PI during the course of the study.
• Assist with the review, collection and tracking of regulatory documents.
• Recorded and distributed study trial minutes from weekly meetings.

Company Name

SpinalMotion, Inc. (Biotechnology)

Position Held

Clinical Monitoring Coordinator

Dates

0000 - Present

Details

• 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.
• Prepared IRB applications for protocol submissions that followed IRB requirements.
• 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
• Developed plans for research subject recruitment

Company Name

SpinalMotion,Inc. (Biotechnology)

Position Held

Clinical Monitoring Assistant

Dates

0000 - Present

Details

• 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

Company Name

Bearcom

Position Held

Sales Coordinator

Dates

0000 - Present

Details

• Assigned to build a top-producing sales team and managed the sales department that led to n 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.