Summary
Overview
Work History
Education
Skills
Timeline
AdministrativeAssistant

Jessica Speece

Lewisville,NC

Summary

Detail-focused Senior Clinical Research Coordinator with strong experience in clinical trial management. Strong ability to coordinate and manage both site activities and project requirements concurrently, ensuring regulatory compliance at all times. Strengths include high-level organizational skills, exceptional communication abilities, and a solid understanding of medical terminology. Have made significant contributions by streamlining processes for improved efficiency in previous roles. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.

Overview

26
26
years of professional experience

Work History

Sr. Clinical Research Coordinator

Accellacare
Winston-Salem, North Carolina
05.2022 - Current
  • Managed clinical trial lifecycle at a site level from beginning to end of the study (feasibility stage to closeout).
  • Experienced with a variety of research technologies in areas of Training, EDC, IWRS, eCOA, CTMS, Central Labs, SAE, IRB, Recruitment, and Decentralized platforms.
  • Coordinated multi-therapeutic trials in the areas of internal medicine, endocrinology, vaccine, pediatrics, neurology, dermatology, device, urology, gynecology, and gastroenterology.
  • Experienced with clinical trial subject recruitment and retention strategies.
  • Provided technical support to investigators regarding data entry and query resolution into electronic case report forms.
  • Maintained accurate records of study documents including source documents, CRFs, informed consents, laboratory results, and regulatory documents.
  • Ensured that all research activities were conducted according to protocols and in compliance with local laws and regulations as well as GCP guidelines.
  • Created detailed reports summarizing study status, patient recruitment efforts, enrollment trends.
  • Coordinated patient visits, including scheduling appointments and collecting informed consent forms.
  • Developed and maintained regulatory documents for clinical trials.
  • Performed quality control checks on eCRF data by reviewing discrepancies reported by Data Management staff or generated from database queries.
  • Monitored study progress and documented adverse events in accordance with protocol guidelines.
  • Reviewed source documentation for accuracy of data entered into eCRFs.
  • Served as a liaison between sponsors, investigators, vendors throughout the duration of the study.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
  • Collected, processed and delivered specimens from trial participants.
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
  • Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
  • Took vital signs and collected medical histories as part of study protocols.
  • Placed orders for supplies and medications to be used in studies.
  • Conducted screening interviews to determine eligibility of possible subjects.
  • Educated participants on studies and anticipated outcomes.
  • Monitored subject enrollment and tracked dropout details.
  • Participated in Site, Sponsor, FDA, and IRB audits.
  • Organized investigator meetings, prepared agendas, collected presentations, and took minutes at meetings.
  • Experienced with MS Office applications (Word, PowerPoint, Excel, Outlook, etc.)

Manager of Clinical Operations

Accellacare
Winston-Salem, North Carolina
05.2017 - 05.2022
  • Maintained relationships with key stakeholders in order to facilitate effective communication between them and the organization.
  • Organized training sessions for staff members on topics related to clinical operations procedures.
  • Participated in strategic planning initiatives aimed at optimizing organizational resources while maintaining high standards of care delivery.
  • Developed strong working relationships with physicians, nurses, administrators, and other healthcare providers across multiple locations.
  • Resolved escalated issues from patient concerns or complaints.
  • Formulated strategies for improving clinical operations, including process optimization and workflow design.
  • Utilized active listening and interpersonal communication skills to build professional relationships with patients, clinical staff and other stakeholders.
  • Provided onboarding and coaching to new hires to help each feel comfortable in job positions and prepared to handle various responsibilities.
  • Established solid relations with leadership and staff by attending board meetings and coordinating interdepartmental information exchanges.
  • Maintained communication and transparency with Leadership, Investigators, Sponsors, CRA's, and medical staff.
  • Recruited individuals bringing talent, well-developed skills sets and passion for helping others, effectively building exceptionally gifted team of personnel.
  • Developed and implemented operational policies to ensure compliance with all applicable regulations.
  • Reviewed employee performance and provided ongoing feedback and coaching to drive performance improvement.

Assistant Manager of Clinical Operations

Accellacare
Winston-Salem, North Carolina
07.2016 - 05.2017
  • Completed feasibilities questionnaires to build a healthy pipeline of clinical trials across multiple therapeutic areas of research.
  • Assisted management with creating & presenting a variety of reports, training, staff meetings, and staff resourcing.
  • Organized training sessions for new hires to familiarize them with the workplace environment.
  • Assisted in the development of operational strategies to ensure efficient and productive operations.
  • Collaborated with management on developing strategic plans for achieving business goals.
  • Planned and led team meetings to review business results and communicate new and ongoing priorities.
  • Assigned work and monitored performance of project personnel.

Sr. Clinical Research Coordinator

PMG Research
Winston-Salem, North Carolina
03.1999 - 07.2016
  • Manage the clinical trials from site selection, enrollment, follow-up, and completion.
  • Maintained accurate records of study documents including CRFs, informed consents, laboratory results.
  • Provided technical support to investigators regarding data entry and query resolution into electronic case report forms.
  • Ensured that all research activities were conducted according to protocols and in compliance with local laws and regulations as well as GCP guidelines.
  • Conducted pre-study site visits to demonstrate our site capabilties and compliance with protocols and applicable regulations.
  • Reviewed source documentation for accuracy of data entered into eCRFs.
  • Served as a liaison between sponsors, investigators, vendors throughout the duration of the study.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
  • Collected, processed and delivered specimens from trial participants.
  • Took vital signs and collected medical histories as part of study protocols.
  • Placed orders for medications and supplies to be used in studies.
  • Conducted screening interviews to determine eligibility of possible subjects.
  • Educated participants on studies and anticipated outcomes.
  • Monitored subject enrollment and tracked dropout details.
  • Trained new team members on the principles of Good Clinical Practice and ICH regulations.
  • Coordinated patient visits, including scheduling appointments and collecting informed consent forms.
  • Performed quality control checks on eCRF data by reviewing discrepancies reported by Data Management staff or generated from database queries.
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
  • Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.

Education

Bachelor of Science - Exercise Science

Appalachian State University
Boone, NC
05-1994

Associate of Arts - General Studies

Wilkes Community College
Wilkesboro, NC
05-1991

Skills

  • Clinical trial management
  • Site management
  • Informed consent process
  • Medical writing
  • Patient recruitment
  • Data collection
  • IRB submissions
  • Clinical research ethics
  • Trial management
  • Dispensing oversight
  • Adverse event tracking
  • Trial oversight
  • Meeting coordination
  • Investigational product management
  • Good clinical practice
  • Documentation management
  • Records maintenance
  • Report preparation

Timeline

Sr. Clinical Research Coordinator

Accellacare
05.2022 - Current

Manager of Clinical Operations

Accellacare
05.2017 - 05.2022

Assistant Manager of Clinical Operations

Accellacare
07.2016 - 05.2017

Sr. Clinical Research Coordinator

PMG Research
03.1999 - 07.2016

Bachelor of Science - Exercise Science

Appalachian State University

Associate of Arts - General Studies

Wilkes Community College

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Jessica Speece