Sr Clinical Trials Assistant resume example with 13+ years of experience

Jessica Claire
  • Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
  • Home: (555) 432-1000
  • Cell:

Detail-oriented professional with 3 plus years of clinical research experience and a track record of efficient management of clinical trials in accordance with ICH, GCP, and FDA guidelines.

Professional Experience
Sr. Clinical Trials Assistant, 03/2012 to Current
Guardant Health, Inc.San Diego, CA,

Key Responsibilities

  • Effectively manage over 85 US clinical sites as the main Study Team and Investigator/Site Personnel Contact
  • Mentor new hire CTAs during their onboarding and first six months of employment
  • Lead CTA on a high profile Phase III Hypercholesterolemia trial with 120+ sites while overseeing 2 other CTAs and working as the main point of contact between the Study Team and the CTA team.
  • Member of the FAST Force team, a newly developed team of CTAs with a proven track record of site response that is responsible for all Feasibility and Site Interest for all studies.
Clinical Trials Assistant, 10/2010 to 03/2012
Nuvance HealthFishkill, NY,

Key Responsibilities

  • Act as a central contact for the clinical team and site personnel for designated project communications, correspondence, and associated documentation during various study stages
  • Manage the collection, review, and processing of essential documents from multiple research sites for submission to investigational product shipment authorization parties
  • Coordinate key feasibility activities, including the processing of confidentiality disclosure agreements, site interest surveys, and other questionnaires
  • Maintain various clinical systems that track site compliance and performance within project timelines
  • Assemble and distribute study binders, CRF’s, and other supplies to participating clinical sites

Therapeutic Area Experience

  • Hypercholesterolemia, Phases II, III
  • Ulcerative Colitis, Phase III
  • Non-Small Cell Lung Cancer, Phase III
  • Multiple Early Development Trials, Phase 1
Clinical Research Coordinator , 08/2009 to 10/2010
Cornerstone Healthcare GroupShawnee, OK,

Key Responsibilities

  • Recruited and coordinated the trial subjects covering informed consent, screening and inclusion of the subjects, adhering to safety and compliance issues
  • Coordinated and managed the clinical trial through direct communication with the sponsor and other authorities, visit coordination, biological sampling, time management and product accountability.
  • Collected and managed data utilizing source documents and case report forms, registered and managed AEs and SAEs, filed and archived various study documents, managed monitoring visits
  • Close-out of the clinical trial, audit preparation, assisted in the final study report.

Therapeutic Area Experience

  • Allergic Rhinitis, Phase II, III, IV
  • Asthma, Phase II, III
Patient Care Technician, 2009 to 10/2009
Baptist HealthBenton, AR,
  • Served as an integral member of the primary patient care team, working along side doctors, nurses and other healthcare professionals to provide direct patient care in a post-surgical environment.
  • Performed clinical procedures including, but not limited to the following: Obtaining Vitals ((temperature, heart rate, pulse ox, blood pressure and weight), Performing ECGs, Placement, Removal, and care of indwelling Catheters, Application of basic dressings, Drawing blood and obtaining any other specimens ordered by provider
  • Provided outstanding patient care under the supervision of the Registered Nurse and other Health Care team members.
Information Associate , 11/2007 to 2009
Saint Luke's HospitalCity, STATE,
  • Performed clerical duties related to transcription of physician orders, maintaining the patient record, direct admitting process and bed allocation, maintaining unit supplies, assessing patient charges, and other duties as assigned.
  • Served as receptionist for visitors and patients.
  • Coordinated all communications on unit.
Bachelor of Arts: Chemistry , Expected in 2008
University of Missouri-Kansas City - Kansas City, MO

Graduated with Departmental Honors

Bachelor of Arts: Spanish, Expected in 2008
University of Missouri-Kansas City - Kansas City, MO

Study Aboard in Xalapa, Mexico (2008)

Study Aboard in Granada, Spain (2007)

Relevant Training
  • InFORM 4.6 Comprehensive Training
  • Introduction to Medidata RAVE
  • EDC: Impact on Monitoring
  • Managing Site Recruitment as a CRA
  • Adverse Event Workshop, Part 1 and 2
  • CRA Shadowing Visit
Certifications and Awards

Barnett Accreditation - Fundamentals GCP EXAM for support staff, 97%, 2012

Certified Clinical Research Professional, Society of Clinical Research Associates, 93%, 2011


Photography, Traveling, Reading, Blogging, Volunteering for a Local Animal Rescue Group

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Resume Overview

School Attended

  • University of Missouri-Kansas City
  • University of Missouri-Kansas City

Job Titles Held:

  • Sr. Clinical Trials Assistant
  • Clinical Trials Assistant
  • Clinical Research Coordinator
  • Patient Care Technician
  • Information Associate


  • Bachelor of Arts
  • Bachelor of Arts

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