Jamie Howlett, MS

ad4wv4@r.postjobfree.com 616-***-**** Open to Relocate. Located in West Bloomfield, MI.

Dear Hiring Manager:

I am writing in regards to the open position that is currently available. Based on the job requirements, I feel that I am a strong candidate for the position.

In my previous roles as all of the following Clinical Research Manager, Senior Clinical Research Coordinator, Clinical Research Coordinator and Behavior Therapist I have been responsible for project management of assigned studies, proactively planning, driving, and tracking execution and performance of deliverables/timelines/results to meet country commitments. I am also accountable for performance for assigned protocols at a site in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards, and adverse event reporting requirements. In addition, I review Monitoring Visits Reports and escalate performance issues and training needs to study personnel and/or functional vendor and internal management as needed. I have experience coordinating proposal development, including: proposal and project timeline development; scheduling and planning meetings for collaborators; contributing to the development of drafts of research protocols, recruitment and consent documents, and data collection tools; developing staffing plans; and assisting with the development and writing of budget justifications. In addition, I have experience leading communication with select stakeholders, conducting, coordinating, and managing data collection, entering data, and reviewing or editing data to ensure data is collected according to regulations and protocols.

I believe that my skills and experience would make me a valuable asset to your team. I am committed to ensuring compliance with all protocol and regulatory requirements, and to providing accurate and timely reports. I am confident that I can be successful in your open position and contribute to the success of your organization.

Thank you for your time and consideration.

Sincerely,

Jamie Howlett

BEHAVIOR SCIENTIST / COMMUNITY ADVOCATE / CLINICAL RESEARCHER / RESEARCH MANAGER

Highly resourceful and knowledgeable Clinical Research Coordinator / Manager with a wealth of experience managing and overseeing all aspects of clinical trials from project management and protocol development through data analysis and reporting. Skilled at managing and meeting budgeting requirements while ensuring adherence to FDA regulations. Adept at monitoring progress against timelines, coordinating activities between internal departments, and developing innovative solutions to operational challenges. Proficient at conducting risk assessments before commencing any new trial or study initiatives. Known for creating training materials for staff members regarding Good Clinical Practices (GCP) while maintaining / nurturing relationships with external vendors / sponsors related to various studies or trials.

AREAS OF EXPERTISE

Clinical Research Cross-Functional Communication Behavioral Science Community Advocate Research Coordination

Clinical Trials Protocols / Procedures Quality Assurance Training / Coaching Data Management

Monitoring / Tracking Grants Interviewing Regulations / Compliance

KEY PROPOSITION

>Adept at understanding and establishing project plans, devising protocol synopsis, leading study plans, and conducting / reporting activities (all aspects of the clinical trial).

>Skilled at providing clinical functional review and expertise on the assigned projects / tasks.

>Proficient at reviewing large documents such as literature reports, clinical research protocols, and template documents as assigned.

CAREER HIGHLIGHTS

Michigan Head Pain & Neurological Institute

Ann Arbor, MI

Clinical Research Coordinator July 2023 - Current Position

Successfully completed various projects related to the development of drugs and therapies and efficiently managed the data collection processes. Acknowledged for strong understanding of regulatory guidelines to ensure all studies were conducted according to protocol and patient safety requirement.

Key Initiatives:

●Partnered with multiple stakeholders to ensure successful study execution and compliance with regulations and provided support throughout all phases of the clinical trial process.

●Employed exceptional communication skills to effectively collaborate with other members of the research team including physicians, nurses, and other healthcare professionals involved in clinical trials or observational studies.

●Recognized for keen attention-to-detail while ensuring accuracy for data entry into databases or electronic medical records systems used by the institution's researchers.

●Prioritized tasks efficiently to ensure deadlines were met without sacrificing work quality.

●Ensured protocols were followed correctly during the trial process ensuring valid conclusions could be drawn from collected data.

●Delivered benefits to patients participating in studies through new treatment options made available due successful outcomes generated by the team’s efforts.

●Managed multiple participants calls for high recruitment volume as well as implemented tailored strategies to improving recruitment procedures well maintaining customer service professionalisms.

●Site managed all aspects of 30 clinical research trials.

●Managed the regulatory aspects of clinical trials.

●Project managed teams and directly involved in the creating, planning, implementing, managing, and monitoring both teams and projects.

●Successfully organized and lead team training programs as well as national instated guidelines and new and promising evidence-based business operations for successful protocol completion while maintaining high repertoire with all stakeholders and study sponsors.

●Expertly communicated with all stakeholders, vendor staff and clinical research members and obviously with the P.I. members involvement to manage and plan the research initiatives to better manage my projects that lead all board members to expertly complete the research protocols beyond the sponsors and P.I.’s expectations.

●With clear FDA and IRB regulatory mandates clearly stated in all research protocols clearly being followed and assumed upon conditions of the FDA and IRB were clearly followed.

●The involvement of the communities macro- and micro- ecosystems where expertly handled to bring about nationwide accreditations and broad acknowledgments to the point of publication by a family doctor of a research participant’s family.

●Lead nationwide programs that trained all sponsor staff including site members and myself on how to better handle I.P and newly executed staff members and Directors as well as the P.I.s

●Worked largely on protocol amendments with site-initiated research studies that I managed solely throughout the begin to close out of every site investigator-initiated study.

Cosmetic Laser Dermatology, A West Dermatology Company January 2022 - June 2023

La Jolla, CA

Clinical Research Coordinator

Successfully completed various projects related to the development of drugs and therapies and efficiently managed the data collection processes. Acknowledged for strong understanding of regulatory guidelines to ensure all studies were conducted according to protocol and patient safety requirement.

Key Initiatives:

●Partnered with multiple stakeholders to ensure successful study execution and compliance with regulations and provided support throughout all phases of the clinical trial process.

●Employed exceptional communication skills to effectively collaborate with other members of the research team including physicians, nurses, and other healthcare professionals involved in clinical trials or observational studies.

●Recognized for keen attention-to-detail while ensuring accuracy for data entry into databases or electronic medical records systems used by the institution's researchers.

●Prioritized tasks efficiently to ensure deadlines were met without sacrificing work quality.

●Ensured protocols were followed correctly during the trial process ensuring valid conclusions could be drawn from collected data.

●Delivered benefits to patients participating in studies through new treatment options made available due successful outcomes generated by the team’s efforts.

●Managed multiple participants calls for high recruitment volume as well as implemented tailored strategies to improving recruitment procedures well maintaining customer service professionalisms.

●Site managed all aspects of 30 clinical research trials.

●Managed the regulatory aspects of clinical trials.

●Project managed teams and directly involved in the creating, planning, implementing, managing, and monitoring both teams and projects.

●Successfully organized and lead team training programs as well as national instated guidelines and new and promising evidence-based business operations for successful protocol completion while maintaining high repertoire with all stakeholders and study sponsors.

●Expertly communicated with all stakeholders, vendor staff and clinical research members and obviously with the P.I. members involvement to manage and plan the research initiatives to better manage my projects that lead all board members to expertly complete the research protocols beyond the sponsors and P.I.’s expectations.

●With clear FDA and IRB regulatory mandates clearly stated in all research protocols clearly being followed and assumed upon conditions of the FDA and IRB were clearly followed.

●The involvement of the communities macro- and micro- ecosystems where expertly handled to bring about nationwide accreditations and broad acknowledgments to the point of publication by a family doctor of a research participant’s family.

●Lead nationwide programs that trained all sponsor staff including site members and myself on how to better handle I.P and newly executed staff members and Directors as well as the P.I.s

●Worked largely on protocol amendments with site-initiated research studies that I managed solely throughout the begin to close out of every site investigator-initiated study.

Paradigm Clinical Research Center, Inc. December 2020-January 2022

La Mesa, CA

Senior Clinical Research Coordinator & Research Manager

Effective utilized interpersonal skills to interact professionally and diplomatically with patients, families, sponsors, co-workers, investigators, and others.

Key Initiatives:

●Demonstrated key skills in prioritizing workflow to meet deadlines, often under pressure of conflicting demands, while maintaining accuracy and effectiveness of work.

●Employed problem solving skills to work effectively and meet research goals, with minimal supervision.

●Managed employee retention.

●Manage the entire clinical trial cycle: site assessments, pre-trial assessments, site initiation, subject retention, monitoring, and close-out.

●Direct staff: educating clinical research coordinators, training, compliance, travel, scheduling and coverage, evaluations, and others.

●Oversee all required study startup documentation and timelines on assigned study protocols.

●Collaborate with the executive team to ensure staffing, start-up, and trial goals are met.

●Maintain effective, courteous, and ongoing communication with staff, sponsor, research participants, and PI during the course of trials.

●Ensure enrollment goals of trials are met by determining effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.

●Oversee training for all protocols as well as requirements for regulations.

●Support the team and investigators in overall conduct of trials.

●Ensure monitoring visits and sponsor/FDA audits are completed successfully.

●Facilitate a supportive work environment/culture.

●Site managed all aspects of 30 clinical research trials.

●Managed the regulatory aspects of clinical trials.

●Project managed teams and directly involved in the creating, planning, implementing, managing, and monitoring both teams and projects.

●Successfully organized and lead team training programs as well as national instated guidelines and new and promising evidence-based business operations for successful protocol completion while maintaining high repertoire with all stakeholders and study sponsors.

●Lead nationwide programs that trained all sponsor staff including site members and myself on how to better handle I.P and newly executed staff members and Directors as well as the P.I.s

●Expertly communicated with all stakeholders, vendor staff and clinical research members and obviously with the P.I. members involvement to manage and plan the research initiatives to better manage my projects that lead all board members to expertly complete the research protocols beyond the sponsors and P.I.’s expectations.

●With clear FDA and IRB regulatory mandates clearly stated in all research protocols clearly being followed and assumed upon conditions of the FDA and IRB were clearly followed.

●Continuously analyzes the performance of the departments and adjust to meet the expected goals.

●Ensures that research milestones are met in the desired time frame by building effective teams.

Awarded Accolade: The involvement of the communities macro- and micro- ecosystems where expertly handled to bring about nationwide accreditations and broad acknowledgments to the point of publication by a family doctor of a research participant’s family. In addition, I was awarded Managerial Duties my first year within the Research and Development field as well as handled all HR and handled to completion HR duties as well as hire and execute staffing necessities.

Positive Behavior Supports Corporation April 2016 – December 2020

Grand Rapids, MI and San Diego, CA

Behavior Therapist

Implemented and coordinated ongoing research-based behavior interventions for the successful achievement of goals in the client’s treatment plan. Utilized project management tools and techniques to inform the research-based programs.

Key Initiatives:

●Successfully led improvements with continuous communication of complex data sets with the multidisciplinary team while monitoring of all data sets.

●Instituted multidisciplinary clinical trials and treatments at all levels of the client’s lifespan ecological systems.

●Successfully achieved project objectives through the utilization of pattern predictions from data analysis and ongoing research-based clinical trials.

●Analyzed time-dependent complex data that successfully cleared any delays in progress and identified growth opportunities.

●Project managed teams and directly involved in the creating, planning, implementing, managing, and monitoring both teams and projects.

●Successfully organized and lead team training programs as well as national instated guidelines and new and promising evidence-based therapies.

●Collaborated with all healthcare providers, academic advisors to implement large-scale goals reaching the board-certified analysts and national goals as well as single lead-initiated projects to assist in this project initiative.

●Executed research-lead evidence-based procedures to improve upon current therapies and modalities as well as initiated collaborated empathetic insights to assist the families with my own skills and talents.

●Expertly communicated with all stakeholders, board certified analysts and families to manage and plan the behavioral projects as well as expertly lead the monitoring across the council board members.

Single Lead Accolade: Project managed multiple sites for the client therapeutic programs in both the community, in home for multiple Analysts.

CAREER HIGHLIGHTS CONTINUED

Centria Healthcare April 2016 – August 2019

Grand Rapids, MI

Behavior Therapist

Utilized nonviolent crisis prevention intervention (CPI) approved procedures to de-escalate problem behaviors and ensure safety during crisis situations.

Key Initiatives:

●Provided therapy for the direct implementation of applied behavior analysis (ABA) interventions.

●Addressed problematic behaviors in accordance with Positive Behavior Support techniques.

●Successfully tracked data for skill acquisition and problem behaviors daily.

●Collaborated with all healthcare providers, academic advisors to implement large-scale goals reaching the board-certified analysts and national goals as well as single lead-initiated projects to assist in this project initiative.

●Executed research-lead evidence-based procedures to improve upon current therapies and modalities as well as initiated collaborated empathetic insights to assist the families with my own skills and talents.

●Expertly communicated with all stakeholders, board certified analysts and families to manage and plan the behavioral projects as well as expertly lead the monitoring across the council board members.

Grand Valley State University January 2013 – April 2016

Grand Rapids, MI

Clinical Research Assistant

Served as a Clinical Research Assistant for a translational research grant project focused on the assimilation of healthy eating behaviors and exercise behaviors in refugee adolescents who participated in a workshop twice a week with exposure to factors modeling optimal behaviors.

Key Initiatives:

●Executed protocol management initiatives and worked on a research project that analyzed the impacts that a nutrition enrichment class had on physical exercise and overall well-being in a group of refugees for Dr. Vogelzang.

●Collaborated with leadership to design, administer, coordinate, and monitor the clinical trials for the research project.

●Interviewed research participants, collected data, and performed outcome evaluations of participants’ progress in behavior education research.

●Assisted in the analysis and evaluation of complex data gathered during participant interviews and research trials.

●Managed / monitored clinical sites, project managed all aspects of the research project, and lead clinical research trials.

●Commended for ensuring the staff, site, supplies, and devices followed the research design, regulations, and clinical objectives.

●Aided in the implementation of the study education plan that resulted in the successful expansion of the participants’ English language, health, and nutrition knowledge.

●Successfully trained, coached, mentored, and supervised clinical research staff.

EDUCATION

Master of Science, Complementary and Integrative Healthcare; National University, December 2020

Master of Science, Psychology, Behavior Analysis, Purdue University

Bachelor of Science in Allied Health Sciences, Grand Valley State University

CERTIFICATIONS

Certification In Reiki (Level I, II, and III / Master), Accredited Training Provider: Virtued Academy International, November 2022

Health and Nutrition Life Coach Certificate, CPD Course, Transformation Services, Inc. November 2022

Women’s Holistic Health Coach Teacher Trainer, Yacep Course, November 2022

Mindfulness And Meditation Teacher Certificate, Yacep Course, November 2022

Advanced Clinical Research Project Manager Certification, CCRPS, May 2022

200 HR Yoga Teacher (200 HR RYT), Yogarenew, December 2022

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