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Study Start Up Primary Clinical Research Associate Resume Example

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JC
Jessica Claire
, , 100 Montgomery St. 10th Floor (555) 432-1000, resumesample@example.com
Professional Summary

Focused and results driven SSU & Primary CRA with prior experience as a Sr. CRC. Specializing in Hematology, Oncology, Precision Medicine, Neurology, and Cardiology with 5+ years experience. Seeking a challenging and responsible position in SSU where I can contribute my knowledge, experience, and leadership in clinical research.

Skills
  • Study start up
  • Monitoring Visits
  • Conducting SIV's & SEV's
  • Patient Screening
  • QA following GCP, FDA guidelines
  • Completing case report forms/resolving queries
  • Preparing for and conducting monitoring/auditing visits
  • Strong presentation skills
  • Accomplished leader
  • Regulatory tracking
  • Compound synthesis
  • Western Blots
  • Informed consent
  • Specimen collections
  • Data collection & analyzation
  • Protocol adherence
  • Employee training
Professional Experience
04/2020 to Current Study Start Up/Primary Clinical Research Associate Massachusetts General Hospital | Lynn, MA,
  • Currently working for DOCS-Icon as an SSU CRA under Amgen FSP. Began as PCRA (primary) monitoring trials across the southeast US. Primary monitoring activities included performing SIV’s, off-site monitoring visits during the pandemic. Remote SDV/SDR for sites. Worked with pediatric oncology trials (Phase I), cardiovascular, neurology (migraine), and dermatology (CSU) trails also as well as adult oncology (MM). Other duties are activating sites, assisting sites with query resolution, investigator signatures, open issues and pages. Sites included universities, hospitals and research centers around the southeast as well as northeast sites.
  • As an SSU CRA, study start-up has included site evaluation visits, compiling site documents for activation, and site transitions to PCRA’s. Also collecting all required start up materials (IP and kit tracking, EDC access for staff) for sites and evaluating sites for possible selection.
08/2018 to 04/2020 Senior Clinical Research Coordinator Ascension Health | Sand Springs, OK,
  • Aflac Precision Medicine Program (APMP) Lead coordinator at both Egleston and Scottish Rite campuses. Spearheaded program and trial start up creating regulatory documents and processes. Assisted PI's in creating general flow algorithms and conduct of program. Conduct clinical trial using Next Generation Sequencing (NGS) via Ashion. Consent and enroll recurring and refractory solid tumor, Leukemia, and brain tumor patients to APMP after screening. Coordinate pathology specimen requests, processing specimens, and germline blood or saliva sample collection via clinic and inpatient unit. Genetic reports generated from Ashion analytics sent directly to me then disseminated to patients primary physicians, clinical team and families. Enter genetic data from reports into EDC. Organize and create agenda of patients to be discussed and mentioned at our Molecular Tumor Boards. Assist with program budgeting and payments of invoices as well as study amendments and SOP's. Adhere to standards in all areas, including data collection, research protocols and regulatory reporting. Successfully led key points in the development of program which resulted in a large number of enrollments beyond expectation and positive results during first year.
  • Coordinator for Pediatric MATCH (COG) Phase II Developmental Therapies trial and Compassionate Use Studies
01/2016 to 08/2018 Clinical Research Coordinator - Oncology Benaroya Research | Seattle, WA,
  • Hematology/Oncology Aflac Cancer & Blood disorders center; Maintained data pertaining to research projects, completing source documents/case report forms, performing data entry of patient abstracted information in to EMR systems; discussing and consenting patients for research studies, preparing research case reports in quantitative measures and narrative form; reviewing medical records and conduct screening for recruitment of study participants; assisting with quality assurance and tracking regulatory submissions; interfacing with study sponsors, monitoring and report Serious Adverse Events, resolving study queries; and collecting and processing study specimen including tissue, bodily fluids, and other pathological specimens according to research protocol; study start up and site visits for investigator initiated studies, set up monitoring visits and SIV's
  • Coordinated Solid Tumor/Rare Tumor Clinical Trials (COG) Phase II-III, Leukemia/Lymphoma Clinical Trials (COG) Phase III-IV, and Developmental Therapies Clinical Trials (Aflac) Phase I-II
02/2015 to 02/2016 Clinical Research Assistant Atlanta Center For Medical Research, ACMR | City, STATE,
  • Created and maintained screen books and charts for all assigned studies, Prepared and ran study visits, ensured accuracy of source documents and assessments, Filing of lab results, EKG results, and designated charts, Completed data entry for all eCRFs, as well as paper CRF completion and transmission, Completion of headers, Assisted Coordinators in assessments, blood pressure and urine drug screens, Assisted Coordinators with scheduling, copying, faxing, and other clerical tasks. Aided Coordinators in the facilitation of study monitoring visits
  • Conducted Medical as well as Psychology clinical trials Phase III-IV for respiratory, cardiovascular, and mental disorders
Therapeutic Experience

Oncology, US

Pediatric Cancer

  • Precision Medicine/Next Generation Sequencing (Phase I-IV)
  • Neuroblastoma (Phase I-IV)
  • Leukemia/Lymphoma (Phase I-IV)
  • CNS Brain Tumors (Phase I-IV)
  • Wilms Tumor (Phase I-III)
  • Rhabdomyosarcoma (Phase II-IV)
  • Retinoblastoma (Phase II-IV)
  • Osteosarcoma/Ewings Sarcoma (Phase I-IV)
  • HPV Vaccine Trials

Adult Cancer

  • Multiple Myeloma (Phase II)

Cardiology, US

  • ASCVD (Phase IV)
  • Dyslipidemia (Phase IV)

Neurology, US

  • Migraine (Phase IV)

Psychiatry, US

  • Schizophrenia (Phase III-IV)
  • Bipolar Disorder (Phase II-IV)

Respiratory, US

  • Asthma (Phase III-IV)

Infectious Disease, US

  • Influenza (Phase III)
Certifications
  • CCRP Certified Clinical Research Professional, 2020 SOCRA
  • BLS/CPR certified through American Heart Association, 2020
Education
Expected in 2015 Master of Science | Clinical Research Morehouse School of Medicine, Atlanta Georgia, GPA:

Cancer Prevention & Control Certification Program - 2015

Expected in 2012 Bachelor of Science | Biology-Chemistry Winston-Salem State University, Winston-Salem, GPA:
Affiliations/Memberships
  • Member, Society of Clinical Research Associates (SOCRA CCRP) (2017-present)
  • Member, American Association for Cancer Research (AACR) (2015-2017)
  • Member, Children's Oncology Group Member (2016-present)
  • Member, Kappa Alpha Psi Fraternity, Inc. (2011-present)

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Resume Overview

School Attended
  • Morehouse School of Medicine
  • Winston-Salem State University
Job Titles Held:
  • Study Start Up/Primary Clinical Research Associate
  • Senior Clinical Research Coordinator
  • Clinical Research Coordinator - Oncology
  • Clinical Research Assistant
Degrees
  • Master of Science
  • Bachelor of Science