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Sr. Clinical Trials Assistant Resume Example

Resume Score: 70%

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SR. CLINICAL TRIALS ASSISTANT
Profile

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 AssistantApr 2012 to Current
Company Name - City, State

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 AssistantNov 2010 to Apr 2012
Company Name - City, State

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 Sep 2009 to Nov 2010
Company Name - City, State

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 TechnicianJan 2009 to Nov 2009
Company Name - City, State
  • 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 Dec 2007 to Jan 2009
Company Name - City, 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.
Education
Bachelor of Arts, Chemistry 2008University of Missouri-Kansas City - City, State

Graduated with Departmental Honors

Bachelor of Arts, Spanish2008University of Missouri-Kansas City - City, State

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


Interests

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

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Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.

Resume Overview

School Attended

  • University of Missouri-Kansas City

Job Titles Held:

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

Degrees

  • Bachelor of Arts , Chemistry 2008
    Bachelor of Arts , Spanish 2008

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