Austin, Texas Metropolitan Area
Experienced Oversight Monitor/Lead, Clinical Research Associate (CRA), CRA Line Manager, RACT Facilitator, Clinical Trial Manager (CTM) with more than 15 years in the clinical research industry. Broad background in clinical trials management of phase I/II/III trials in various indications. Skilled in Electronic Data Capture (EDC), eSource, Electronic Informed Consents, Electronic Diaries, Onsite and Remote Monitoring, Risk-Based Monitoring, Good Clinical Practice (GCP), Clinical Research, CRO Management, and Clinical Trials. Strong research professional with a Master's in Education and Bachelor's in Healthcare Administration.
Monitoring Visit Report Reviewer - Created study specific annotated reports. - Performed study specific monitoring report review and metrics tracking. Oversight Monitoring Reports Reviewer - Oversaw one additional staff for oversight monitoring report review by assigning study assignments, managing metrics timelines adherence of staff, provides study specific materials and workload. - Conducted oversight monitoring report review for quality and adherence. - Escalated sites and/or CRAs for oversight assessment visits. - Drafted the Clinical Monitoring Plan (CMP) to include oversight monitoring report review expectations. - Provided oversight monitoring report data for an inspection readiness visit. - Drafted the oversight monitoring report job aid. Oversight Assessment Visits Assessor - Created the CRA oversight assessment questionnaire that is completed by the assessor. - Conducted oversight visits of CRO CRA's/ Contract CRA's to evaluate on-site performance of CRA's and/or site performance. - Drafted the Clinical Monitoring Plan (CMP) to include oversight assessment visits expectations. Oversight Quarterly Curriculum Vitae (CV) Reviewer - Reviewed CRA Qualification Checklist compared to CRA CVs. - Performed a risk-based compliance check of the CV Tracker on a quarterly basis. - Oversaw one additional staff for quarterly CV review by assigning study assignments, managing metrics timelines adherence of staff, provides study specific materials and workload. - Drafted the oversight quarterly CV review job aid. Clinical Research Associate - MVs, IP, ISF vs TMF Risk Management Facilitator - Utilized the Clue Points Risk Assessment Categorization Tool (RACT). - Scheduled RACT meetings on a quarterly basis or as needed. - Facilitated the risk management process by collaborating with contributors from each functional area. - Scored each risk based on impact, detectability, and probability, and documented how and by which functional area the risks will be managed.
Project Delivery Management and Oversight: Monitored performance by close interaction with project leadership/functional leadership and ensure that ongoing/revised project documentation and correspondence is accurate and complete. Provided consultation, facilitate metrics collection, and develop action plans in conjunction with Management/Project Leadership/Leads to keep project on time and within budget. Managed and oversaw team activities including appropriate resourcing of staff, staff assignments, quality control and efficiency of project deliverables. Served as an ongoing liaison with Project Team, Sponsor, and management regarding performance of direct reports. Performance Management, Staff Development and Talent Management: Ensured direct reports meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan by conducting quality check of deliverables (on site visits, Central File documentation) and take appropriate remedial action. Met and exceed client expectations by recruiting, retaining, and developing a skilled, experienced, and motivated team. Managed and develop the staff to ensure their performance meets and or exceeds both the business and their own personal goals/objectives through training, mentoring, and allocating staff according to their ability. Supported staff to improve their efficiency and effectiveness at prioritizing work and improving performance evidenced by the work produced, client feedback, audit results and QC measures. Participated in formal staff review processes: performance and salary reviews to corporate standards and timescales. General Operations: Participated in the implementation of department system/standards improvement activities.
Project Delivery Management and Oversight: Monitored performance by close interaction with project leadership/functional leadership and ensure that ongoing/revised project documentation and correspondence is accurate and complete. Provided consultation, facilitate metrics collection, and develop action plans in conjunction with Management/Project Leadership/Leads to keep project on time and within budget. Managed and oversaw team activities including appropriate resourcing of staff, staff assignments, quality control and efficiency of project deliverables. Served as an ongoing liaison with Project Team, Sponsor, and management regarding performance of direct reports. Performance Management, Staff Development and Talent Management: Ensured direct reports meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan by conducting quality check of deliverables (on site visits, Central File documentation) and take appropriate remedial action. Met and exceed client expectations by recruiting, retaining, and developing a skilled, experienced, and motivated team. Managed and develop the staff to ensure their performance meets and or exceeds both the business and their own personal goals/objectives through training, mentoring, and allocating staff according to their ability. Supported staff to improve their efficiency and effectiveness at prioritizing work and improving performance evidenced by the work produced, client feedback, audit results and QC measures. Participated in formal staff review processes: performance and salary reviews to corporate standards and timescales.
Acted as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues. Performed on-site visits and remote visits/contacts. Assessed & managed test article/study supply including supply, accountability, and destruction/return status. Followed-up on CRF data entry, query status, and SAEs.
Provided day-to-day leadership and administrative supervision to a team of local and remote Clinical Research Associates (CRA) and Clinical Trial Associates (CTAs) within the MSM Department, and acts as the department subject matter expert. The MSM will participate in the development and implementation of operational strategies, policies and procedures for the MSM Department, and ensure project deliverables meet client expectations. The MSM will be accountable for multiple projects/clients and expected to manage client relationships and expectations successfully. The MSM maintains a proactive, positive, results oriented work environment.