Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Angela Angstadt

Gettysburg,PA

Summary

Highly qualified Certified research professional skilled in all aspects of clinical trial coordination, protocols, and participant relationships. Experienced in both medical practice and clinical research environments. Demonstrate strong working knowledge of ICH-GCP, company standard operating procedures, regulatory guidelines, protocols and monitoring guidelines. Communicate effectively with medical personnel, colleagues, and study participants. Consistently perform at peak professionalism, adhering to code of ethics and business standards. Experienced in multiple study areas, including oncology, diabetes, hypertension, gastrointestinal, gynecology, autoimmune disorders, cardiovascular and renal. Recognized for initiative, organization, time and task management, sound problem solving skills and flexibility. Have worked with many EDC systems such as Medidata, Oracle, IBM, Trialmanager and Inform. Other platforms include Clario, ERT, Bioclinia, YPrime and Bracket. EMR experience include, EPIC, Cerner and Allscripts.

Overview

40
40
years of professional experience
1
1
Certification

Work History

Clinical Research Coordinator

Medix Staffing
01.2021 - Current

Cultivated productive relationships with patients, families, and healthcare professionals, optimizing patient progress in meeting short and long-term wellness goals.

Manage 12 Oncology trials all done remotely.

Actively engaged in professional development, deepening awareness of current developments in clinical research and healthcare.

Showed commitment to and performed consistently in high performance environment

Maintained patient/client focused approaches to work with the ability to interact professionally within a patient/client organization and provide presentations.

Possessed willingness to work in a diverse environment and value the importance of teamwork.

  • Streamlined data collection processes for increased efficiency and accuracy in study results.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
  • Collected, evaluated, and modeled collected data.
  • Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle

Clinical Research Manager

Meritus Health
11.2004 - Current

Maintained working knowledge of and ensured compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study specific procedures.

Creating and maintaining screen books and charts for all assigned studies

Prepare visits for the next day, ensuring accuracy of source documents and assessments

Filing of lab results, EKG results, and other communication in designated charts

Timely completion of data entry for all eCRFs, as well as paper CRF completion and transmission

Documented and conducted appropriate correspondence regarding adverse events, including multiple severe adverse events

Ensured study documents are tracked, file, maintained, and archived in audit-ready condition

Aided in the facilitation of study monitoring visits

Built relationships with investigators and site staff

Participated in Investigator and other external or internal meetings as required

Performed on-site facility inspection

  • Negotiated contracts with vendors, securing competitive pricing for critical study supplies and services.
  • Conducted thorough risk assessments for each project, implementing mitigation strategies where necessary to protect patient safety.
  • Facilitated training sessions for study staff, enhancing their understanding of protocol requirements and procedures.
  • Evaluated the performance of individual studies against established benchmarks, identifying areas for potential improvement.
  • Increased patient enrollment in clinical trials by developing targeted recruitment strategies and outreach programs.
  • Mentored junior staff members, providing guidance on best practices in clinical research management.
  • Coordinated efforts among investigators, sponsors, and regulatory agencies to ensure seamless execution of clinical trials.
  • Streamlined document management processes to facilitate faster review cycles and reduce administrative workload.
  • Followed informed consent processes and maintained records.
  • Gathered, processed, and shipped lab specimens.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.

Clinical Research Coordinator

Dr. Trent Nicols
06.1994 - 10.2004


Maintained working knowledge of and ensured compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study specific procedures.

Maintained compliance with required trainings in the Learning Management System (LMS/E-Learning).

Performed all tasks relevant to study participant selection, including written and oral consent, screening and educating subjects, caregivers, and referral sources on protocol specific details and expectations.

Expertly conducted full range of patient and protocol assessments, including safety and efficacy, vital signs and EKGs.

Active contributor in investigator/sponsor and coordinator meetings, sharing valuable study data and insight as requested.

Communicated professionally to internal and external study teams the performance of recruitment tactics.

Increased study engagement both with patients and site staff along with support study compliance requirements to meet sponsor goals.

Adapt to new and innovative solutions for patient recruitment challenges and fast-paced environments.

Maintenance of study regulator documents, including screening and enrollment logs, drug accountability logs, subject identification logs, site signature logs

Completion of case report forms (CRFs)

Coordinate and oversee clinical assessments of clients participating in clinical trial studies of major depression, hypertension and diabetic medications

Research Specialist

Gettysburg Hospital
03.1984 - 02.2004
  • Trained colleagues in specialized software programs, increasing departmental productivity through optimized workflows.
  • Championed the implementation of standardized procedures across all stages of the research process to improve consistency and comparability between studies.
  • Advised management on strategies for utilizing research findings in practical applications and product development.
  • Collaborated with cross-functional teams to design and execute innovative research projects.

Education

Bachelor of Science - Business Administration

York College of Pennsylvania
York, PA
12.1983

Skills

Competent in Written and Verbal English

MSOffice Products (word, excel, power point)

Fast Learner

Adaptable

Flexible

Extreme Attention to Detail

Ability to Travel without Limitations

Strong Knowledge of Medical Terminology

Electronic Medical Records

Documentation& Reporting

Strong Work Ethic

Time Management

Certification

ICH Good Clinical Practice (GCP) | Cardiopulmonary Resuscitation (CPR) Health Insurance Portability and Accountability Act (HIPAA) | Blood Borne Pathogens Certification

  • Certified Clinical Research Coordinator ACRP - 2005
  • GCP Training - 2015, 2023

Timeline

Clinical Research Coordinator

Medix Staffing
01.2021 - Current

Clinical Research Manager

Meritus Health
11.2004 - Current

Clinical Research Coordinator

Dr. Trent Nicols
06.1994 - 10.2004

Research Specialist

Gettysburg Hospital
03.1984 - 02.2004

Bachelor of Science - Business Administration

York College of Pennsylvania
Angela Angstadt