Clinical Project Associate Ii Resume Example

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(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
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.
  • 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
  • Gilead ‘GThanks’ Award for Bioavailability/Bioequivalence Tracker.

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Resume Overview

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