Luz A. Herrera

• Oversaw the inventory of 998 vehicles and updated the status of all idle and out-of-service vehicles on a daily basis.
• Ensured that all vehicles were available for rental in a timely and cost-effective manner.
• Supervised that non-rental vehicles were turned in for repair and coordinated the transfer of cars in need of repair and/or maintenance to the respective vendor/facility.
• Inspected vehicles and requested maintenance tasks be completed within specific time-frames.
• Collected Accident Reports kits and communicated with the claims team by gathering supporting documentation such as check-in/out slips, signed rental agreements, police report numbers, impound documentation, witness statements, damage estimates and photos, and related supporting documents.

• Monitored safety of women with breast cancer and oversaw consent procedures to comply with local and international regulations.
• Set up and disbanded trial study centers to manage clinical study activities for 4 sites.
• Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
• Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
• Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
• Followed drug storage procedures to comply with protocols and SOP requirements.
• Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
• Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
• Submitted monitoring reports and follow-up letters to facilitate internal and external communication.

Embedded in Merck Sharp & Dohme

• Provided clinical study start up expertise and assisted Lead CRA in the preparation of IRB submissions including review of site-specific informed consent and assent forms for at least 8 clinical trials of different diseases.
• Contacted in average 16 clinical sites for specific requests (e.g. enrollment updates, missing documentation, data entry timeliness, data query follow-up, CDA finding follow-up, and action Item resolution or other sponsor specific CRA tasks).
• Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
• Organized and maintained research study regulatory documents in sponsor binder to maintain accuracy and integrity.
• Collected, reviewed, and processed essential documents and identified issues that site needs to address.
• Sourced, planned, and analyzed of ancillary supplies with preferred vendors.
• Resolved issues involving distribution of ancillary supplies, including local & International shipments, etc.
• Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
• Assistance and/or participation in planning and conduct of Investigator’s Meetings as necessary.

• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies, achieving a 98% recruitment rate.
• Maintained compliance with protocols covering patient care and clinical trial operations.
  Collected data and followed research protocols, operations manuals, and case report form requirements.
• Gathered, processed, and shipped lab specimens.
• Followed informed consent processes and maintained records.
• Worked with principal investigators and sponsors to facilitate daily trial activities and comply with research protocols.
• Monitored unit budget to meet financial objectives for spend rate and funding.
• Updated inventory, expiration and medication logs to maintain current tracking documentation.
• Collected pertinent data and calculations to aid physician in interpreting results.
• Completed EKGs and other tests based on patient presentation in office.
• Obtained and documented patient medical history, vital signs and current complaints at intake.
• Helped improve patient outcomes by educating and advising on relevant treatments and care.