Michael Pittman
Clinical Research Associate at Miltenyi Biomedicine- Claim this Profile
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Bio
Credentials
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Monitoring Oncology Clinical Trials Program
Barnett InternationalJul, 2023- Nov, 2024 -
ACRP Good Clinical Practice (GCP) Simulation
ACRP - Association of Clinical Research ProfessionalsDec, 2022- Nov, 2024 -
GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
CITI ProgramJun, 2021- Nov, 2024
Experience
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Miltenyi Biomedicine
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Germany
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Clinical Research Associate
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Mar 2023 - Present
• Monitor and ensure site compliance with the clinical protocol, company SOPs, and ICH/GCP guidelines.• Identify, assess, select, initiate, and close-out appropriate clinical trials sites for company-initiated trials (CITs)• Train, support, and motivate clinical trial sites and investigators on conducting the trial.• Identify site needs and site-related issues, escalate them and/or initiate corrective actions when necessary, providing solutions for site staff to facilitate that conduct of the clinical trial.• Ensure appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAEs).• Facilitate the resolutions of clinical queries to investigative staff in accordance to the trial specific monitoring plan.• Report protocol deviations and develop issue resolution plans.• Review, collect, and maintain essential documents required for clinical trial application.• Writing visit reports and filing and collecting trial documentation and contributes to resolve findings.• Build and maintain solid and long-term professional relationships with investigators and site staff.• Ensure timely communication of information between Clinical Development Department and site staff.• Preparation, maintenance, and archiving of TMF according to applicable SOPs and GCP.• Coordinate the writing and revising of CRA-related SOPs to reflect current US clinical activities and performs revision control for all North American documents and facilitates the reviews and approvals between the North American and German Quality Departments.• Actively participates as a member of the cross-functional project team; internally with the Departments of Quality Assurance, IT, Regulatory Affairs, R&D, Legal, and Clinical Marketing; externally with CROs, Competent Authorities, Ethics Committees, and GCP consultants. Show less
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Clinical Trials Associate
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Jan 2022 - Mar 2023
• Manage various vendors, including medical imaging services, laboratory services, and a contract research organization.• Calculate weekly, monthly, quarterly, and annual performance metrics on all vendors to ensure exceptional performance.• Disseminate critical data trends and information to key stakeholders to identify stress points for our clinical trials.• Develop intricate databases using Excel to track crucial samples and overall vendor performance.• Assist the Vice President and Senior Clinical Project Manager with various business administrative duties, such as tracking invoices.• Collaborate with the Clinical Data Manager in creating and maintaining clinical databases for our oncology trials.• Perform data query reviews on laboratory specimens, blood samples, and medical imaging. Show less
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Ora, Inc.
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United States
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Clinical Trials Associate
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Jun 2021 - Nov 2021
• Ensured study documentation, communication, training and data collection is aligned with study protocol adherence, and all applicable SOPs, regulations and guidelines • Set-up and maintained the Trial Master File / electronic Trial Master File, and using applicable filesharing platforms for clinical projects. • Drafted and reviewed study-related documents and templates including study protocols, informed consents, source document templates, study plans, study related logs, etc. • Participated in study start-up (including Investigator Meeting), study maintenance and study closeout activities. • Collected and reviewed site regulatory documents for accuracy and completion. • Prepared essential documents package to support investigational product release for study and site approval. • Created regulatory packages for IRB/IEC submission for study and site initial submission as well as applicable study and site continuity report submissions and close-out submissions. • Assembled and distributed regulatory binders to clinical sites. • Ordered and shipped study-related supplies to clinical sites. • Supported Clinical Research Associates during monitoring visits to help ensure that any missing documents are filed within the eTMF and the site binder. • Supported project management activities including drafting meeting agendas/minutes, drafting communication, and maintaining CTMS and the study tracker(s). • Provided support to Clinical Operations for implementing process improvement actions, remaining current on all relative and applicable SOPs, and participating in departmental training sessions. Show less
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Massachusetts General Hospital
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United States
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Hospitals and Health Care
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700 & Above Employee
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Administrative Research Coordinator
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Jan 2021 - Jun 2021
• Managed study and grant funds.• Supervised all Clinical Research Coordinators and a co-op student.• Served as the COVID-19 safety officer for the clinic and lab to ensure everyone's safety and compliance to rules and regulations.• Coordinated 5 different clinical research studies on depression.• Recruited patients to participate in research studies.• Applied for grant funding.• Conducted other important administrative tasks to guarantee smooth operations.
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Clinical Research Coordinator
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Jun 2020 - Dec 2020
• Managed dozens of patients through various clinical trials and research studies.• Maintained study-related records using GCP. • Created and drafted IRB-regulated documents, such as research protocols, consent forms, and ads.• Communicated adverse events, protocol deviations, and more to the IRB.• Analyzed data using SPSS, Microsoft Excel, and REDCap.• Recruited patients via Craigslist, Rally, college listservs, and ResearchMatch and phone screened them.• Prepared manuscripts, conference posters, and conference talks.• Assisted with administrative and other study-related tasks. Show less
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The Brain Injury Association of Virginia
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Richmond, Virginia Area
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Research and Data Intern
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Jan 2020 - May 2020
• Conducted qualitative analysis on all 450 Information & Referral phone calls from 2019. • Created 11 checkboxes in Salesforce that capture sensitive, useful data, including cognitive deficits, behavioral health, mental health, social wellbeing, finances, employment, and more. • Streamlined the Information & Referral process, making it more efficient and effective. • Transformed the case notes and records into useful data points that will enable the organization to have a better understanding of Virginia's brain injury population. Show less
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University of Richmond
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Higher Education
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700 & Above Employee
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Senior Honors Thesis Researcher
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Aug 2019 - Apr 2020
• Conducted an experiment that investigated the effects of inanimate objects as subjects with different verbs and syntactic structures on various fixation times during reading.• Designed 160 unique sentences with True/False comprehension questions that participants read and completed.• Implemented eye-tracking technology to record eye movements and fixation times.• Analyzed the data using SPSS syntax.• Presented my research at University of Richmond's Psychology Department's thesis defense and wrote a thesis. Show less
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Orientation Advisor (OA)
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Mar 2019 - Aug 2019
• Led a group of 60 transfer students through the University of Richmond's New Student Orientation.
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Peer Advising Associate (PAA)
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Dec 2018 - Aug 2019
• Assisted over 100 incoming transfer students with the construction of their class schedules.• Provided guidance and resources to ensure an easier transition into UR's environment.
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Student Research Assistant in Psycholinguistics
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Jan 2019 - May 2019
• Conducted an experiment that investigates the effects of lexical repetition and syntactic structure on various fixation times during reading.• Employed eye-tracking technology to track fixation times.• Trained new lab members to use eye-tracker.• Led participants through the experiment.• Analyzed data using SPSS.• Attended weekly lab meetings.
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University of Mississippi Medical Center
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United States
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Hospitals and Health Care
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700 & Above Employee
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Summer Undergraduate Research Experience Intern
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Jun 2019 - Aug 2019
• Immunostained inner ear tissue sections of rats, mice, macaques, and humans to detect various proteins in the inner hair cells, outer hair cells, supporting cells, and neurons. • Implemented RNAscope technology to investigate the RNA of intact cells in sections. • Utilized a cryostat to obtain sections of inner ear tissue, specifically the cochlea. • Maintained a clean, organized laboratory space and the upkeep of various lab specimens in EDTA. • Attended weekly journal clubs that examined the forefront of otolaryngology research. Show less
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New York State Department of Health
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United States
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Wellness and Fitness Services
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700 & Above Employee
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Intern
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May 2018 - Aug 2018
• Conducted a solo bioinformatic project to find the genetic etiology of Ebstein's Anomaly, a rare, congenital heart defect. • Sequenced 50 genes from 65 patients using HaloPlex technology. • Sifted through 7880 genetic variants and classified their severities using the guidelines established by the American College of Medical Genetics and Genomics (ACMG). • Designed my own PCR Analyses to test 16 variants. • Employed Next Generation Sequencing (NGS) and Sanger Sequencing to verify tested variants. • Gave an oral presentation of research findings at the REU Symposium in Albany, NY, and I wrote a paper titled: “Genetic Variants Identified in Ebstein’s Anomaly Using Bioinformatic Analysis and Tools”. Show less
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Education
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2018 - 2020
University of Richmond
Bachelor of Arts - BA, Psychology -
2017 - 2018
J Sargeant Reynolds Community College
Associate of Science - AS, Biology, General
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