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clinical research operations manager ii for the pediatric trial network ptn resume example with 20+ years of experience

Jessica Claire
  • Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
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Professional Summary

A CCRC certified clinical research coordinator offering 8+ years of experience in clinical research coordination. Demonstrated ability to support the management and coordinate the tasks of multiple clinical research studies. Expert in liaising between different departments.

Certifications and Licenses
  • Registered Nurse Practitioner in the State of Kansas and Missouri
  • CCRC Certified Clinical Research Coordinator
  • CPN Certified Pediatric Nurse
  • BLS
,
Skill Highlights
  • Network Management - Pediatric Trial Network NICHD
  • HIPPA Compliance
  • GCP
  • Clinical Data Collection
  • Protocol Development
  • Clinical Study Monitoring
  • IND/IDE Application and Maintenance
  • Case Report Development
  • Investigator Initiated Studies
  • Study Feasibility Assessment
  • Regulatory Submission and Maintenance - IRB
  • Audit Preparation
Professional Experience
Clinical Research Operations Manager II for the Pediatric Trial Network (PTN), 03/2012 - Current
Ascension Health Chesterfield, MO,

Clinical Research Operations Manager for the Pediatric Trial Network (PTN) Department of Research Development and Clinical Investigation


  • Collaborates with professional staff to plan, supervise and evaluate all aspects of the clinical and research operations conducted by the NICHD-sponsored Pediatric Trial Network.
  • Provides programmatic direction and general programmatic supervision of all departmental clinical research coordinators, and staff in cooperation with the Chief Scientific Officer (CSO) who serves as the site Core Director of the Pediatric Trial Network (PTN).
  • Acts as research liaison with outside institutions, and mentors internal departments regarding research activities related to the PTN.
  • Assist in the development of appropriate training operational tools, resources and capabilities that foster consistency, efficiency, and strong relationships between internal and external partners, research sites, and the PTN.
  • Overall trial management of the PTN through interfacing and or collaboration with Medical Research Administration and mentoring of assigned research coordinators to ensure that tasks are performed with quality, on schedule, within budget, and in compliance with applicable regulatory requirements, in accordance with PTN policies.
  • Assuring compliance with applicable Internal Review Board (IRB), Institutional Bio Safety Committee (IBC), and HIPAA Privacy and Security requirements.
  • Provides programmatic direction and general programmatic supervision of all departmental clinical research coordinators, and staff in cooperation with the Chairman of the Department of Medical Research who serves as the site Core Director of the Pediatric Trial Network (PTN).
Clinical Research Operations Manager I for the Pediatric Trial Network (PTN), 01/2011 - 03/2012
Crystal Clinic Orthopedic Center Wadsworth, OH,
  • Collaborates with medical staff, nursing staff and support services to determine staffing standards.
  • Monitors scheduling practices based on service requirements and established productivity guidelines.
  • Provides management oversight for the CMH Central Research Coordinator "pool".
RN-Clinical Research Coordinator, 10/2006 - 01/2011
Children's Mercy Hospital City, STATE,
  • Coordinates pediatric clinical trials on a contractual basis within the hospital.
  • Responsible for IRB submission, trial budget preparation, recruitment, informed consent, documentation, drug accountability and study maintenance.
Rheumatology Nurse Manager, 10/1996 - 10/2006
Children's Mercy Hospital City, STATE,
  • Directed staff in the delivery of outcome focused care.
  • Responsible for nursing personnel management, day-day operations of clinic, coordination of physician scheduling, continuous quality improvement, development of programs, and services, fiscal management for clinic.
RN Rheumatology Clinic Staff Nurse, 11/1993 - 10/1996
Children's Mercy Hospital City, STATE,
  • Responsible for direct care of clinic patients, educated patients and their families on Juvenile Rheumatoid Arthritis, Lupus, Dermatomyositis and other auto immune diseases.
  • Provided medication teaching; side effects and administration, including parent injection and patient self injecting of medications. Administered IV medications, IVIG, Cytoxan and Remicade in the outpatient clinic setting.
  • Documentation of patient care and teaching.
  • Coordinated care for patient with other clinics and ancillary services
RN-Staff Nurse Inpatient Adolescent Unit, 04/1990 - 09/1993
Children's Mercy Hospital City, STATE,
  • Involved in direct patient care, assessed patient; identifying physiological, safety and educational needs.
  • Documented assessments, interventions and evaluations in the medical report.
  • Demonstrated competencies in clinical skills for assigned areas.
  • Planned, provided and evaluated teaching, including discharge instructions.
  • Managed and operated equipment safely. Utilized standard precautions.
  • Demonstrated ability to manage time and prioritize work.
RN- Day Charge Nurse Inpatient Adolescent Unit, 01/1990 - 09/1993
Children's Mercy Hospital City, STATE,
  • Responsible for assigning nursing staff to patient care for day shift, provided adequate staffing for night shift staff according to patient census and work load.
  • Worked in collaboration with nursing supervisor regarding admissions and discharge of patients.
  • Participated in physician rounds and communicated plan of care to appropriate staff.
  • Participated in staff annual performance appraisal process.
Student Nurse Technician, 05/1989 - 04/1990
Children's Mercy Hospital City, STATE,
  • Assisted nursing staff in the care of all patients, including bathing, dressing changes and feedings.
  • Provided quality patient care.
Education and Training
Master of Science: Nursing, Expected in 2012
-
University of Mary - Kansas City, Missouri
GPA:
Status -

January 2011-2012 Master of Science in Nursing University of Mary Master in Business Administration Kansas City, Missouri

Bachelor of Science: Nursing, Expected in 1993
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Webster University - Kansas City, Missouri
GPA:
Status - August 1992-1993 Webster University Kansas City, Missouri Bachelor of Science Nursing
Diploma of Nursing: Educational, Expected in 1989
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St. Luke's School of Nursing - Kansas City, Missouri
GPA:
Status -

August 1986-1989 St. Luke's School of Nursing Kansas City, Missouri Diploma of Nursing

Professional Affiliations

ACRP - Association of Clinical Research Professionals


RAPS - Regulatory Affairs Professional Society

Skills
  • Clinical Research, Operations
  • Pediatric RN
  • Rheumatology
  • Personnel Management
  • Budgets
  • Teaching
  • Clinical Trials Maintenance
  • Recruitment
  • Trial Management

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Resume Overview

School Attended

  • University of Mary
  • Webster University
  • St. Luke's School of Nursing

Job Titles Held:

  • Clinical Research Operations Manager II for the Pediatric Trial Network (PTN)
  • Clinical Research Operations Manager I for the Pediatric Trial Network (PTN)
  • RN-Clinical Research Coordinator
  • Rheumatology Nurse Manager
  • RN Rheumatology Clinic Staff Nurse
  • RN-Staff Nurse Inpatient Adolescent Unit
  • RN- Day Charge Nurse Inpatient Adolescent Unit
  • Student Nurse Technician

Degrees

  • Master of Science
  • Bachelor of Science
  • Diploma of Nursing

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