Clinical Research Social Worker

Aimee M. Carpenter, MA

Cell: 615-***-**** Email: ************@*****.***

Industry Preference: Clinical Research

Over 24 years in clinical research type roles. Dependable, reliable, and adaptable professional, with solid understanding and proven ability in identifying methods to boost staff productivity and organizational behavior across various corporate environments. Hands-on and hardworking leader; with strong record of integrity and dependability. Results- oriented with excellent communication and interpersonal skills. Accustomed to performing challenging tasks with precision and attention to detail. Proficient in working all faucets of the health and medical field in many different capacities and would prefer a job working within research.

Proficient with: Horizon, DataBasics, Activate, WorkDay, Box, iAchieve, Cornerstone, Firecrest, CTMS, Clarity, Preclarus, Veeva Vault, ICOMaster, OnCore, BMS and Gilead DIS, Microsoft Office Suite, Nitro, Lotus Notes, SPSS, Oracle Inform 6.0, RCD Onsite, QRD, Advantage EDC, REDCap, Blue Belt Training, and 5S Training.

Education

oMaster of Arts in Psychology with Concentration in Mediation and Conflict Resolution

University of the Rockies, Colorado Springs, CO – 3.8GPA Graduated 2013

oBachelor of Arts in Social Science

Ashford University, Clinton, IA Graduated 2010

Work Experience

ICON PLC – 100 % Homebased Employee

Title: Site Activation Lead April 2022 – Nov 2024

Job Duties: Lead clinical trial start-up activities by understanding the client objectives and assist in the development of the plan for country and site distribution. Oversees day to day delivery of all aspects of site activation in the projects assigned. Ensures that each project has a site activation plan and that the study is being conducted in accordance with that plan and in an effective manner which meets sponsor timelines and expectations and is in compliance with ICON/client KPIs, ICON/client SOPs, reporting norms, appropriate regulations and ICON’s quality standards. Lead sponsor initiatives such as kick-off meetings, bid defenses, project update and status calls, and other communications. Utilize project management skills to optimize performance and collaboration to ensure successful study outcomes.

PPD – 100 % Homebased Employee

Title: Start Up Team Manager (equivalent to SAL at ICON)

Oct 2021 - March 2022

Job Duties: Collaborates with multiple team members in a matrix environment for the effective delivery of site activation within the assigned projects. Oversee site activation for assigned projects according to timelines and quality standard. Assists with coordination of the flow of information between PPD teams, clients, or functional departments involved in site activation. Develops recommended plans/guidelines for project implementation

using PPD tools. Monitors and analyzes project status to ensure successful progress and completion of all assigned projects and provide metrics to upper management. Performs risk identification and provides contingency planning. Collaborates with PPD teams to manage all financial and contractual aspects of the studies related to site activation. Works within the team to establish appropriate controls to ensure that project resources and expenses are aligned with budgets with accountability to US/Canada Project Management.

Administers the technical and operational aspects of the site activation portion of the assigned projects, including coordination of feasibility, site contracts, and country teams in a matrix environment and manages the assigned scope of work against timelines, costs, and quality. Participates with functional area leads to identify and evaluate fundamental issues pertaining to successful site activation, interpret data on complex issues, make good business decisions and ensure solutions are implemented. Develops customer relationships in alignment with assigned projects

ICON PLC – 100 % Homebased Employee

Title: Senior Study Start Up Associate (Regulatory) Jan 2021 – Oct 2021

Job Duties: Work as a lead SSUA in multiple studies, accelerating site startup through effective execution of regulatory approvals and timely collection of critical documents key for patient enrollment. Both project management role and sponsor facing. Responsible for the preparation and coordination of submissions to regulatory, ethics, and other bodies. Develop, finalize, and review Master and Country Specific Informed Consent Forms. Working on over 2-3 studies and up to 25-30 sites at one given time. Working with all regulatory documents, including but not limited to the first review of Informed Consent Forms (ICFs), making submissions to central/local IRBs, and maintaining study amendment documents from sponsor to site. Work with the clinical and contracts team as well as site activation leads (SALs) to quickly get sites up and running efficiently and effectively. Help to train/mentor new SSUAs coming into the study startup position. Analyze and work to improve process improvement coming from a compliance background. Work on contract and budget amendments for a liaison between sponsor and sites, working with the clinical team, PM, and sponsor. Working on studies in all different indications.

ICON PLC – 100 % Homebased Employee

Title: Study Start Up Associate II (Regulatory) Dec2020 – Jan 2021

Job Duties: Work as a lead SSUA in multiple studies, accelerating site startup through effective execution of regulatory approvals and timely collection of critical documents key for patient enrollment. Project management and sponsor facing. Responsible for the preparation and coordination of submissions to regulatory, ethics, and other bodies. Develop, finalize, and review Master and Country Specific Subject Information Sheets/Informed Consent Forms. Working on over 2-3 studies and up to 25-30 sites at one given time. Working with all regulatory documents, including but not limited to the first review of Informed Consent Forms (ICFs), making submissions to central/local IRBs, and maintaining study amendment documents from sponsor to site. Work with the clinical and contracts team as well as site activation leads (SALs) to quickly get sites up and running efficiently and effectively. Help to train/mentor new SSUAs coming into the study startup position. Analyze and work to improve process improvement coming from a compliance background. Work on contract and budget amendments for a liaison between sponsor and sites, working with the clinical team, PM, and sponsor. Working on studies in all different indications.

ICON PLC – 100 % Homebased Employee

Title: Study Start Up Associate I (Regulatory) July 2019 – Dec 2020

Job Duties: Worked as a lead on multiple studies. Worked on over 2-3 studies (sponsors) at a time and up to 25- 30 sites. Worked with all regulatory documents, including but not limited to the first review of Informed Consent Forms (ICFs), making submissions to central/local IRBs, worked with site activation, and maintaining study amendment documents from sponsor to site. Project management and sponsor facing, especially for smaller sponsors. Worked with the clinical and contracts team as well as site activation leads (SALs) to quickly get sites up and running efficiently and effectively. Helped to train/mentor new SSUAs coming into the study startup position. Analyzed and worked to improve process improvement. Worked on contract and budget amendments for a liaison between sponsor and sites, working with the clinical team, PM, and sponsor. Worked on studies with all different indications.

VANDERBILT UNIVERSITY MEDICAL CENTER – home based, office based in Nashville, TN

Title: Clinical Research Services Consultant II (Project Manager) Dec 2018 – July 2019

Job Duties: Phase I, II, III, and IV clinical trials from study creation (protocol and ICF development, site specific guidance document templates, working with study funders, data base creation, IND submissions), study startup (IRB submissions, protocol training, process flow for all sites, drug ordering/invoicing, budget/contract support, SIV for sites) throughout the final closeout stage. Worked as the “sponsor” for IIT studies within Vanderbilt.

Collaborate with the Vanderbilt University Human Research Protections Program (IRB) and assist with the optimal application of the Federal, State, and local laws, guidance documents, institutional policies, and IRB policies on complex research and regulatory issues in conjunction with the team(s) to identify solutions and develop improvement processes. Setting up the main study trial within Vanderbilt University (sponsor) while managing all additional sites that become a part of the study within the United States. Emphasis on oncology trials.

ICON PLC – 100 % Homebased Employee

Title: Study Start Up Associate I (Regulatory) Sept 2016 – Dec 2018

Job Duties: Accelerating site startup through effective execution of regulatory approvals and timely collection of critical documents key for patient enrollment. Project management. Worked with over 15-25 sites at one given time. Worked with all regulatory documents, including but not limited to the first review of Informed Consent Forms (ICFs), making submissions to central/local IRBs, and maintaining study amendment documents from sponsor to site. Worked with the clinical and contracts team as well as site activation leads to quickly get sites up and running efficiently and effectively. Analyzed and worked to improve process improvement.

VANDERBILT UNIVERSITY MEDICAL CENTER – Nashville, TN

Title: Translational Research Coordinator Mar 2016 – Sep 2016

Job Duties: Project management activities, worked closely with PI’s directly to gather key data management points, as well as programming of study specific algorithms. Worked with Phase I, II, III, and IV studies

VANDERBILT UNIVERSITY MEDICAL CENTER – Nashville, TN

Title: Clinical Data Research Specialist Nov 2014- Mar 2016

Job Duties: Worked from study startup (SIV) stage to study close out process. Phase I, II, III, and IV with an emphasis in oncology studies. In charge of over 30 studies at one given time period. Clinical data input from patient records to sponsor specific computer programs. Worked with direct sponsor as well as CRO’s. Worked with sponsor monitors (CRAs), nurses, and PI’s, to maintain good data collection and high data integrity. Data review, cleaning, and reconciliation. Worked though audits, CAPAs, and data base locks.

MILLIPORE (MERCK) – Temecula, CA

Title: Research Scientist II/Lab Manager 2007-2012

Job Duties: Made monoclonal antibodies in the laboratory from mice inoculations, fusions, to creating enough to market. Helped create contracts for procurement, and took courses on 5S training.

UNIVERSITY OF CALIFORNIA, IRVINE – Irvine, CA

Title: Supervisor, Compliance 2002–2004

Job Duties: Laboratory audits, IACUC board member, modified pre-clinical protocols (veterinary portion) for animal trials. Wrote CAPA’s and did follow up to make sure they were completed in a timely manner.

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