Clinical Research Start Up
Resume:
Melissa Haley
Albers, Illinois, 62215
**************@*****.***
PROFESSIONAL EXPERIENCE
ICON Clinical Research Specialists, 320 Seven Springs Way #500, Brentwood, TN 37027 Study Start Up Associate II (remote) Jan 2022-Present
Interacting and collaborating with additional internal and external customers to predict start up timelines
Ensuring all site activation requirements are met prior to IP release/site activation
Ensure that all essential documents needed for site activation are collected/QC any potential issues are identified and escalated (as necessary)
Filing and query resolution in eTMF; Veeva vault
Ability to work with shifting priorities in order to meet customer demand
Analyze data and metrics effectively in addition to using various industry leading technology platforms.
Have been lead SSU on 75% of the projects I have been assigned
Have been recognized by Site activation leads for 100% of the projects that I have participated Washington University School of Medicine, 660 S. Euclid Ave St. Louis, MO 63110 Clinical Research Specialist (hybrid) Jan 2020 – Nov 2021
Subject matter expert in regulatory submissions and project management (Single patient compassionate treatment submission to FDA, industry sponsored studies, secondary institutional studies, retrospective projects)
Monitor study start up (SSU) metrics with use of commercial and local IRB oncology studies, coordinate with internal budget teams to ensure SIV is coordinated timely.
Audit new study projects for quality control processes. Developed audit tool to establish a permanent auditing program for the oncology department. Invited by AACI to present findings conference in Chicago, IL.
FDA audit preparation and review during on site audits. Provided regulatory support and guidance for auditor.
Train new regulatory coordinators in the study start up process (in person or remotely)
Troubleshoot study start up team queries, Advise staff in time saving processes o Develop SOP’s, work instructions and checklists on internal processes for admin and regulatory team Washington University School of Medicine, 660 S. Euclid Ave St. Louis, MO 63110 Clinical Research Supervisor Jan 2016 – Jan 2020
Coordinate administrative support team, scheduling site visits (team of 5)
Coordinate meeting with regulatory start up team weekly regarding roadblocks to activating trials/timeline, conflict resolution
Participate in meetings with management, other supervisors and staff regarding policy or process changes. Communicate new policies to individual teams and during departmental meetings. SOP development
Able to multitask several start up projects using Good Clinical Practice (GCP) while supporting IND, IDE, IDV submission projects and emergency treatment submissions to FDA Washington University School of Medicine, 660 S. Euclid Ave St. Louis, MO 63110 Clinical Research Coordinator – Regulatory Jan 2005 – Jan 2016
Coordinate administrative support for cancer clinical trials (research)
Communicate with internal department staff as well as external pharmaceutical companies for IND & IDV submissions to the FDA & local IRB review boards
Answer queries from internal and external customers (formal letters, email, etc.)
Advise staff on appropriate methods of communicating updates to their clinical teams
SoCRA training & certification received
EDUCATION
SOUTHWEST INSTITUTE OF TECHNOLOGY Mesa, AZ
(Office Clerk certification (1992), Microcomputer Mgmt (1993) WOODLAND HIGH SCHOOL (Diploma 1991) Streator, IL
ADDITIONAL SKILLS
FDA audit prep, auditing, MSExcel, MsWord, Adobe, Powerpoint, Zoom and MSTeams, Oncore, WCG and Advarra IRB submission portals, Workday, budget review/negotiations, eTMF, Veeva Vault, JIRA
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