Melissa Cabrera Email & Phone Number

Raleigh, Nc, Us

Durham, North Carolina, Us

Durham, North Carolina, Us

Durham, North Carolina, Us

Raleigh, North Carolina, Us

Durham, North Carolina, Us

• Combines a depth of clinical research experience with insight in to client pressures and an ability to develop the right solution for the client. • Delivers study on time, on budget and ensuring highest quality• Provides global project management of the functional elements of a global study, including clinical management, data management, and budgetary oversight

Durham, North Carolina, Us

• Combines a depth of clinical research experience with insight in to client pressures and an ability to develop the right solution for the client. • Delivers study on time, on budget and ensuring highest quality• Provides overall leadership of the functional elements of a global study, including clinical management, data management, and budgetary oversight

Durham, North Carolina, Us

• Oversee data quality segment of data integration project between internal and external Clinical Trials Management Systems (CTMS)• Data Stewarding Lead for new Site Intelligence Management System, mastering person, study and center data across multiple data sources• Department representative for sponsor audits, presenting company investigator compliance procedures. Also serve as audit consultant on automated process involving compliance with Anti-Bribery Laws• Process development for sponsor specific investigator compliance procedures, including budget requirements, training of staff and creation of related technical documentation• Completion of several courses taught by American Management Association, including Presentation Skills, Conflict Management, Managing for Excellence and Getting Results without Authority

Durham, North Carolina, Us

• Develop and implement comprehensive site outreach initiative and strategy plan to enhance our internal investigator database and recruit new investigators• Provide investigator and site performance data and metrics in preparation of bid defenses as well as site forecasting of future site demand by country and indication• Subject Matter Expert on investigator compliance issues (both internal and external), including audit participation and client facing presentations on internal investigator compliance processes• Subject Matter Expert on sponsor specific due diligence of investigators, including Foreign Corrupt Practices Act (FCPA) and related ABL (Anti-Bribery Laws) screening, with presentation experience on client facing audits. • Review and perform root cause analysis on sponsor specific monthly reporting metrics involving protocol specific investigator compliance and site requirements.• Certified trainer of several internal processes, providing required training to various internal clinical personnel on sponsor specific investigator due diligence and the FCPA screening process• Acting manager of Site Intelligence group for a period of 6 months, supervising up to 10 staff. Experience in resource assignment, performance reviews, coaching and mentoring staff.

Durham, North Carolina, Us

* Enter, review, format and maintain investigator and center information in Impact Harmony investigator database.* Proactive monitoring of investigator compliance. Review FDA, OIG, PHS and other regulatory agency actions and makes necessary updates in investigator database. Alert project teams to new compliance issues.* Coordinate receipt of internal investigator compliance reporting forms. Make necessary updates documenting GCP issues in investigator database and alerts project teams to newly added GCP issues.* Perform Sponsor-specific "Due Diligence" reviews of potential investigators for regulatory compliance issues, internal GCP issues and medical license disciplinary actions.* Coordinate responses to the FCPA survey (Foreign Corrupt Practices Act) sent to principal investigators as part of the ABL (Anti-Bribery Laws) approval process.* Training of various clinical personnel (including those in feasibility, monitoring and project management) on investigator compliance and due diligence checks. Document and process creation on due diligence and investigator compliance protocols.* Review and perform root cause analysis on sponsor specific monthly reporting metrics involving protocol specific investigator compliance and site requirements.* Participation in both internal and external audits detailing proactive investigator compliance processes and protocols. * Served as Acting Manager from July 2013 through November 2013, directly supervising eleven employees and performing clinical resource planning and project assignment. * Helped develop new job descriptions for the department, consulted on title changes and updated developmental goals and objectives for each employee. Participated in year end Focal Review of direct reports.

Raleigh, Nc, Us

* Analyze, map and link crimes based on MO, time and location * Predict future pattern criminal events based using statistical calculations and GIS software (ArcMap)* Preparation of Raleigh Police Department's Weekly Crime Numbers and crime numbers for the North Raleigh News* Upload of crime data to City of Raleigh's web-based iMap program

Bs, Biology

Ms, Forensic Science