Marisa Connell
Warren,MI
Summary
Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives.
Overview
6
6
years of professional experience
Work History
FSP Senior Clinical Research Associate I
PPD (a Thermo Fischer Scientific Company)
09.2023 - Current
- Clinical Research Associate on 3 global, multicenter, open-label phase II and IV studies in vaccines in adults
- Performed on-site and remote Interim and Close-Out monitoring visits
- Performed 100% and reduced SDV during on-site visits and performed remote data review using EDC and CDMS for reporting
- Reviewed onsite Investigator files
- Ensured subject safety by overseeing accurate and timely AE/SAE reporting and related follow-up
- Used IVRS for accountability and management
- Managed disruptions in clinical trials conduct during COVID-19 pandemic
- Maintained collaborative relationship with site personnel.
FSP Clinical Research Associate II
PPD (a Thermo Fischer Scientific Company)
02.2023 - 09.2023
- Clinical Research Associate on 3 global, multicenter, open-label phase II and IV studies in vaccines in adults
- Performed on-site and remote Interim and Close-Out monitoring visits
- Performed 100% and reduced SDV during on-site visits and performed remote data review using EDC and CDMS for reporting
- Reviewed onsite Investigator files
- Ensured subject safety by overseeing accurate and timely AE/SAE reporting and related follow-up
- Used IVRS for accountability and management
- Managed disruptions in clinical trials conduct during COVID-19 pandemic
- Maintained collaborative relationship with site personnel.
FSP Clinical Research Associate I
PPD (a Thermo Fischer Scientific Company)
01.2022 - 02.2023
- As Clinical Research Associate performs, and coordinates assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices
- Conducts site visits to determine protocol and regulatory compliance and prepares required documentation
- Develops collaborative relationships with investigative sites and client company personnel.
Clinical Research Manager
Michigan Institute For Neurological Disorders
10.2021 - 12.2021
- Worked as a Clinical Research Manager and a Clinical Research Coordinator on approximately 16 phase I-IV double-blind, open-label, randomized, observational Nervous System (Multiple Sclerosis) clinical trials in adult patients with Primary-progressive MS, Relapsing-remitting MS and Secondary-progressive MS
- Managed and maintained oversight of the research department and staff
- Communicated with clinicians, patients and interdisciplinary staff and was responsible for training incoming research staff
- Completed feasibility questionnaires, site SOP’s, study start up and recruitment activities and managed regulatory submission
- Conducted Clinical Research following specific protocols including collection of vital signs, adverse events, concomitant treatments/medications and assisted staff with laboratory assessments
- Assisted with interim monitoring visits, remote monitoring visits, site initiation visits and close out visits
- Responsible for Investigational Product receipt, accountability, reconciliation and documentation
- Closely worked with multiple IRB’s
Clinical Research Coordinator
Michigan Institute For Neurological Disorders
05.2018 - 10.2021
- Worked as a Clinical Research Manager and a Clinical Research Coordinator on approximately 16 phase I-IV double-blind, open-label, randomized, observational Nervous System (Multiple Sclerosis) clinical trials in adult patients with Primary-progressive MS, Relapsing-remitting MS and Secondary-progressive MS
- Managed and maintained oversight of the research department and staff
- Communicated with clinicians, patients and interdisciplinary staff and was responsible for training incoming research staff
- Completed feasibility questionnaires, site SOP’s, study start up and recruitment activities and managed regulatory submission
- Conducted Clinical Research following specific protocols including collection of vital signs, adverse events, concomitant treatments/medications and assisted staff with laboratory assessments
- Assisted with interim monitoring visits, remote monitoring visits, site initiation visits and close out visits
- Responsible for Investigational Product receipt, accountability, reconciliation and documentation
- Closely worked with multiple IRB’s
Education
BS - Clinical Exercise Science
Grand Valley State University
Grand Rapids, MI04.2018
Skills
- Vendor Management Experience
- Investigator relations
- Study documentation mastery
- Specimen collections
- Site Management
- Team Leadership Qualities
- Coordinating site operations
- Records Maintenance
- Quality Assurance Techniques
- Electronic Data Capture Systems
- Therapeutic Area Expertise
- Study protocols
Candidate Profile
Senior Clinical Research Associate I with more than 6 years of experience in the clinical research industry. Currently working in a Functional Service Partnership (FSP) model. In the FSP model, interfaced directly with the client by collaborating and supporting the local and central study management project teams. As FSP-CRA, was exposed to all stages of a trial lifecycle, including Feasibility and Sites Selection, Start-up activities, Site Initiation, Site Monitoring, and Site Close-out activities, participation in internal sponsor meetings, all onsite and remote site visits, etc. Currently working on 3 trials, in the following indications: [Vaccines]. Experience has ranged from a Clinical Research Coordinator to a Clinical Research Manager. Managed approximately 16 trials and had oversight of the research department while being responsible for onboarding any new research staff. Depth of experience managing clinical trials consists of all phase I-IV Nervous System clinical trials. Performed all types of on-site and remote monitoring visits, interim monitoring visits, site initiation visits and close out visits while also being very familiar with many different clinical and/or client specific systems for trial management. Earned a bachelor’s degree in Clinical Exercise Science from Grand Valley State University.
Licenses Certificates
- PPD Hematology and Oncology Academy Certificate Program, 2022, A comprehensive global development program, designed to ensure that candidates reach a high-quality performance standard within the hematology and oncology therapeutic area; program content provided in a blended learning format with questions built into the modules to ensure learner understanding. Modules include Disease Staging, Metastatic Disease, Systemic Involvement, Treatment Options including Immunotherapy, CAR T-cell therapy, Beyond CAR T-cell therapy, Tumour Types and Tumour Assessments including (i)RECIST and Cheson, CTCAE in oncology trials’, phase I clinical trials and practical hematology and oncology monitoring skills.
- PPD Vaccines Academy Certificate Program, 2022, A comprehensive global development program, designed to ensure that candidates reach a high level of understanding and performance within the vaccines therapeutic area; program content provided in a blended learning format with questions built into the modules to ensure learner understanding. Modules include Basic Immunology for Vaccines, COVID 19 Vaccines, Vaccine Types, General Vaccines, Vaccine Clinical Development, Trial Considerations for Vaccines, and an Operational Platform.
- BLS American Heart Association, 2021
Therapeutic Experience
- Nervous System: Multiple Sclerosis
- Vaccine: Meningococcal, Herpes Virus, RSV
Professional Development
- PPD New Colleague Ambassador Program, 09/2023
- PPD Clinical Foundation Program, 01/2022
- CRA Academy
Timeline
FSP Senior Clinical Research Associate I
PPD (a Thermo Fischer Scientific Company)
09.2023 - Current
FSP Clinical Research Associate II
PPD (a Thermo Fischer Scientific Company)
02.2023 - 09.2023
FSP Clinical Research Associate I
PPD (a Thermo Fischer Scientific Company)
01.2022 - 02.2023
Clinical Research Manager
Michigan Institute For Neurological Disorders
10.2021 - 12.2021
Clinical Research Coordinator
Michigan Institute For Neurological Disorders
05.2018 - 10.2021
BS - Clinical Exercise Science
Grand Valley State University
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