Livecareer-Resume

Clinical Project Associate Ii Resume Example

Love this resume?

By clicking Build Your Own Now, you agree to our Terms of Use and Privacy Policy

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

Clinical research professional with over 4 years of clinical operations experience in managing & organizing phase I-III studies across multiple therapeutic areas which include Cardiology, Oncology, Virology, Genetic Disorders and Respiratory Diseases. Excellent Knowledge of clinical trial documentation, CFR Title 21, ICH-GCP, FDA, MHRA guidelines, Trial Master File structure and purpose. Effective Communication skills with great attention to detail and Collaborative demeanor.

Professional Talents
  • Cross-functional Collaboration
  • Good Documentation Practice
  • Trial Master File Training
  • Public Speaking
Education
Gahlot Institute of Pharmacy Mumbai, Expected in Bachelors of Science : Pharmacy - GPA :
Long Island University Brooklyn, NY Expected in Masters of Science : Drug Regulatory Affairs - GPA :
Work History
Synteract, Inc. - Clinical Project Associate II
San Francisco, CA, 07/2020 - Current
  • Authored study documents including Important Protocol Deviation (IPD) Plan, Trial Master File (TMF) Management Plan, EP ICON/GSI Early Phase Monitoring Manual.
  • Supported study teams with site activation, study start-up, and study management of global phase 1 studies.
  • Facilitated study team and SRT meetings, developed meeting agendas and minutes, ensuring all trial stakeholders were informed of recent study developments, and collaborated with cross-functional teams to meet study deliverables.
  • Managed electronic TMF in accordance to the DIA reference model and good documentation practices to maintain inspection-readiness and contemporaneousness.
  • Mentored an intern and new hire on CPA responsibilities - Created innovative training materials and performed a quality check on the interns project assignments.
  • Provided support to Study Leads for multiple studies across various therapeutic areas.
  • Served as a Study lead backup providing verbal and written communication with study personnel.
  • Obtained and reviewed essential regulatory documents for shipment of investigational drugs.
  • Presented ICH-GCP slides at the SIV.
  • Prepared and presented eTMF updates at Early Phase All-Hands meeting.
  • Maintained the TMF, including set-up, maintenance, review, and archival.
  • Tracked and prepared study-specific information utilizing databases, spreadsheets, and other tools.
Astellas Pharma Us, Inc. - Clinical Study Associate
Tampa, FL, 04/2019 - 05/2020
  • Extensively involved in set-up, maintenance, quality review and tracking of clinical TMF (paper and eTMF)
  • Collected information and coordinated with Regulatory Operations to post trial information on required public forums (eg. clinicaltrials.gov).
  • Supported Fair Market Value process in evaluating study budgets.
  • Reconciled the TMF document trackers generated by the CRO and proposed remediation plan.
  • Served as liaison for vendors and Clinical Operations team.
  • Supported clinical document control efforts in preparing for and participating in audit and/or regulatory inspection.
  • Drafted Clinical Study Oversight Plan with the assistance of the Study Manager.
  • Reviewed and tracked feasibility questionnaires and supported site selection process with the study team during study start-up.
  • Monitored and tracked monitoring visit reports (per CTMS) and ensured filing in TMF.
  • Participated in clinical teams, including scheduling, attending required meetings, and interacted in a positive, professional manner.
Planet Pharma - Clinical Trial Associate
Minnetonka, MN, 09/2017 - 03/2019
  • Assisted Clinical Project Manager in general administrative activities as requested.
  • Collected and reviewed regulatory documents from clinical sites; and communicated with sites regarding trial start-up, conduct, and close-out activities.
  • Ensured all documents are accurately processed in the TMF/eTMF in an efficient and timely manner and adhering to Clinical File Room procedures in the filing, retention, and archiving of essential TMF documents.
  • Setup and maintained clinical trial tracking systems and tools.
  • Facilitated Investigator Meetings, Presentations and Seminars.
  • Coordinated team vendor, budget management, contract negotiations.
  • Maintained vendor tracker and contact list.
  • Participated in sponsor and project-related meetings and appropriately interacted with client and team.
Study Experience
  • First-in-Human
  • Single Ascending Dose
  • Multiple Ascending Dose
  • Drug-Drug Interaction
  • Relative Bioavailability
  • Pediatric Bioequivalence
  • Food Effect
  • Renal/Hepatic Impairment
  • Proof of Concept
  • TQT
Accomplishments
  • Gilead ‘GThanks’ Award for Bioavailability/Bioequivalence Tracker.

By clicking Build Your Own Now, you agree to our Terms of Use and Privacy Policy

Disclaimer
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.

How this resume score could be improved?

Many factors go into creating a strong resume. Here are a few tweaks that could improve the score of this resume:

85Good

Resume Strength

  • Formatting
  • Length
  • Personalization
  • Strong Summary
  • Target Job

Resume Overview

School Attended
  • Gahlot Institute of Pharmacy
  • Long Island University
Job Titles Held:
  • Clinical Project Associate II
  • Clinical Study Associate
  • Clinical Trial Associate
Degrees
  • Bachelors of Science
  • Masters of Science