LiveCareer-Resume

manager project services resume example with 10+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
Summary

Expert clinical researcher and people manager with proven abilities overseeing project operations for multi-component and multi-site programs. Well versed in project and data management, specimen collection and processing, database and Standard Operating Procedures (SOP) creation, and staff training and development for over a decade. Extensive knowledge in clinical trial and cohort study start up, maintenance, and close out with specialty in pulmonary and critical care research. Interests in creating and managing a strategic framework and building collaborative networks to improve public health.

Skills
  • Lean Six Sigma
  • Expert Leadership and Management skills
  • Proficient in all phases of a clinical trial and IDS
  • Experienced with International Council for Harmonization (ICH), Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPAA), Investigational New Drug Application (IND), Nondisclosure Agreement (NDA)
  • Proficiency in Microsoft Office 365 and Smartsheet
  • Clinical Research Regulatory Compliance
  • Skilled with REDCap database creation, data entry, and data exporting.
  • Equipment maintenance
  • Proficient with EPIC/Citrix and PowerChart electronic Medical Record (eMR) systems
  • Project, Operations, and data management
  • Training and staff development
  • Research subject recruitment and retention
  • Staff recruitment and retention
  • Expert communicator and organizer
  • SAS and EPI Info software experience
  • Customer Relationship Management
  • Consultant, Protocols
  • Project planning
  • Schedule management
  • Database, study, and project monitoring
Education and Training
Certificate, Biomedical Focus And Good Clinical Practice: , Expected in 01/2021
CITI Program Training - Online Training,
GPA:
Master of Public Health: Prevention Science, Expected in 08/2020
Rollins School Of Public Health (Emory University) - Atlanta, Georgia,
GPA:
Bachelor of Science: Biological Sciences, Expected in 05/2007
University Of South Carolina - Columbia, South Carolina,
GPA:
: , Expected in
Emory University Continuing Education - Atlanta, Georgia,
GPA:

Project Management: Risk Tools & Techniques (11/1/20)

Introduction to Project Management Certificate (11/17/20)

Project Management: Scheduling Tools & Techniques (12/6/20)

Coaching Effectively (12/11/20)

Experience
Manager, Project Services, 09/2021 to Current
Ihmc RoboticsPensacola, FL,

This position involves extensive mentoring and professional development of direct staff within the Customer Delivery for clinical laboratory research.

  • 40 hours per week
  • Responsibilities include planning, assigning, and directing work; mentoring and training staff; performance management, including appraising performance and guiding professional development, rewarding and disciplining employees as applicable.
  • Supervises a 15+ team of Project Managers and Project Coordinators across the North, South, and Central Americas region.
  • Serves as Lead Manager for 4 Clinical Research Organizations (CRO)/sponsored accounts.
  • Supports and provide guidance to project management team who manages the lab aspects of global clinical trials.
  • Represents the company at Investigator/ Monitor meetings, internal and external authorities of regulatory bodies, and other Face to face meetings.
  • Recruits and hires qualified candidates to fill open positions.
  • Assigns tasks to associates to fit skill levels and maximize team performance.
  • Drives continuous improvement of project delivery process by providing strong leadership.
  • Develops and encourages a culture of delivering “best-in-industry” customer service by ensuring rapid identification of issues and problems and ensuring timely communication of resolution outcomes to both internal and external customers.
  • Ensures studies are planned and executed in accordance with FDA, ICH, and/or EMEA guidelines and that Good Clinical Practices are followed at all times.
  • Participates in initiatives to improve employee engagement to positively impact operational results, customer satisfaction, and employee retention.
  • Serves as liaison between Project Services, internal departments, external vendors, and the sponsor during the life cycle of projects.
  • Leads communications and activities that further enhance the Client Delivery Team results and further strengthen the Client Governance structure.





Associate Director of Research Projects COVID-19 , 10/2020 to 09/2021
Emory University (RADx Tech ACME-POCT)City, STATE,
  • 40 hours per week.
  • Worked closely with Principal Investigator, Co-Principal Investigators, Program Director, and other leadership members to support the program.
  • Provided expertise in project management, scientific theory, clinical research, specimen collection, database creation and management, data entry, and data analysis.
  • Exercised independent judgment in overseeing day-to-day operations of the program.
  • Oversaw weekly schedules, training, and improvement plans for 20+ team members.
  • Directed overall project operations of a multi-component research program conducted at 10 locations, as well as, sporadic community events depending on COVID-19 hotspots throughout North Georgia.
  • Conducted all Institutional Review Board submissions for COVID-19 Point of Care Devices.
  • Maintained regulatory documents for the program.
  • Created program-related materials including but not limited to protocols, informed consent forms, study brochures and videos, advertisements, training materials, and SOPs.
  • Maintained authority over the conduct of the project, including protocol adherence, human subjects, personnel management, and budget oversight.
  • Authorized purchases for supplies and equipment maintenance in excess of $1,000,000+.
  • Coordinated research implementation activities between the institutions and within the collaborative teams and partner settings.
  • Provided leadership in the planning and development of survey instruments, guidelines, procedures, and protocols to recruit participants and collect and manage required data.
  • Coordinates status updates from each functional area.
  • Hired and supervised program staff (20+ team members).
  • Managed operational transitions initiated by changes in regulatory requirements to mitigate negative impact and ensure compliance.
  • Actively engaged in strategic development to optimize program productivity, integrity, and process efficiency.
  • Addressed gaps in technology, capacity, and sourcing.
  • Actively built internal and external relationships to create a collaborative force to diagnose and identify the various COVID-19 variants in the metro Atlanta area.
  • Created and maintained mechanisms for research subjects to make COVID-19 testing appointments and receive results within 24-48 hours.
Clinical Research Coordinator, 01/2013 to 10/2020
Emory University Pulmonary And Crit. Care MedicineCity, STATE,
  • 40 hours per week
  • Worked at the following facilities: Grady, EUH, EUHM, Emory Saint Joseph.
  • Completed regulatory duties of 21+ research studies to include cohort studies and clinical trials.
  • Screened, recruited, and organized documents on all study patients.
  • Collected, processed, and shipped specimens for all patients enrolled into studies.
  • Led and coordinated weekly lab meetings and manage the Research Scholars program, which consists of up to 20+ scholars/medical graduates at a given time.
  • Trained and provided guidance to less experienced staff.
  • Oversaw data management and assisted with protocol creation for research projects.
  • Interfaced with research participants and resolved issues related to study protocols.
  • Authorized purchases for supplies and equipment maintenance in excess of $500,000.
  • Determined effective strategies for promoting/recruiting research participants and retaining participants in clinical trials.
  • Conducted IRB submissions and responded to requests and questions to ensure compliance with applicable regulations; provided leadership in identifying and implementing corrective actions/processes.
  • Created training materials, process guidelines, and SOPs.
  • Provided leadership in determining, recommending, and implementing improvements to policies/processes.
  • Assisted with research study budgets and billing.
  • Scheduled and conduct meetings with study sponsors and study personnel.
  • Collaborated with a multitude of diverse individuals (principal investigators, research coordinators, sponsors, nurses, doctors, laboratory staff, and administrative staff) to ensure all studies are implemented, maintained, and close out in an effective and efficient manner.
Activities and Honors
RADxeMR
  • Led the initiative of testing Over the counter COVID tests for FDA approval. (2020-2021)
  • Institutional Review Board Member (2019-2021)
  • Co-Chair on the Board of Directors of Little Miracles Learning Academy (June 2019-Present)
  • 5 years of Service Award from Emory University (February 2018)
  • PowerChart Access Coordinator (August 2015- December 2021)
  • Southeastern Critical Care Summit (annually 2013-2019)

By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy

Your data is safe with us

Any information uploaded, such as a resume, or input by the user is owned solely by the user, not LiveCareer. For further information, please visit our Terms of Use.

Resume Overview

School Attended

  • CITI Program Training
  • Rollins School Of Public Health (Emory University)
  • University Of South Carolina
  • Emory University Continuing Education

Job Titles Held:

  • Manager, Project Services
  • Associate Director of Research Projects COVID-19
  • Clinical Research Coordinator

Degrees

  • Certificate, Biomedical Focus And Good Clinical Practice
  • Master of Public Health
  • Bachelor of Science
  • Some College (No Degree)

By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy

*As seen in:As seen in: