Clinical Trial Assistant Resume Samples

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Clinical Trial Assistants are responsible for managing the administrative portions of clinical trials during all stages of a trial's process. Skills displayed on example resumes for Clinical Trial Assistants include assisting in initial study-specific team training, conducting clinical team meetings as needed, and contributing to the creation of new platform features with the global development team. Clinical Trial Assistants list bachelor's degrees in health sciences and other related fields on their resume, though having a degree is not a firm requirement for the position.

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1

Clinical Trial Assistant

Maintained the Trail Master File for internal & external audits

  • Tracked & reconciled vendor purchase orders
  • Coordinated multiple calendars
  • Compiled & distributed meeting minutes on a weekly basis
  • Planned & facilitated meetings for over 200 individuals including coordination of international travel, hotel, audio/visual needs, meals, transportation, registration & other necessary details
  • Corresponded regularly with global sites & investigators on trial details, submissions & approvals
  • Created spreadsheets, trackers presentations & documents to meet the specified trial needs
Candidate Info
2
years in
workforce
2
years
at this job
BS
Fashion Merchandising Management
2

Clinical Trial Assistant

Communicated with sites regarding trial start-up, conduct, and close-out activities

  • Collected and reviewed regulatory documents from clinical sites
  • Initiated, maintained, and reconciled Trial Master Files
  • Organized and maintained tracking systems and tools to support the conduct of a clinical study from start-up to close-out
  • Maintained accurate tracking and reporting of study metrics
  • Coordinated communication of tracking information between Clinical Operations and vendors
  • Performed job duties with minimal guidance
Candidate Info
1
year in
workforce
1
year
at this job
BA
Finance
3

Clinical Trial Assistant

Verified accuracy of all eCRF, adverse events, concomitant medication documents, medical histories and operative reports.

  • Tracked data entry, reviewed and resolved queries to comply with study guidelines.
  • Maintained the clinical system within project time-lines.
  • Prepared, processed and filed clinical documentation and reports.
  • To assist in the tracking and distribution of safety reports.
Candidate Info
2
years in
workforce
2
years
at this job
4

Clinical Trial Assistant

Verified accuracy of all eCRF, adverse events, concomitant medication documents, medical histories and operative reports.

  • Tracked data entry, reviewed and resolved queries to comply with study guidelines.
  • Maintained the clinical system within project time-lines.
  • Prepared, processed and filed clinical documentation and reports.
  • To assist in the tracking and distribution of safety reports
Candidate Info
2
years in
workforce
2
years
at this job
5

Clinical Trial Assistant

Accountable for study metrics and tracking systems for clinical studies in the Oncology therapy area complying with ICH/GCP guidelines and Durata SOPs.

  • Provided support to Clinical Operations Management and CRAs
  • Reviewed ICFs and monitoring visit reports for protocol deviations and study status
  • Assisted with study archival of training records for FDA audit preparation
Candidate Info
6
years in
workforce
8
months
at this job
AS
Business Administration
BS
Professional And Leadership Studies
6

Clinical Trial Assistant

  • Assisted with audit reports and organized site visits for senior associates
  • Conducted account reviews and reconciled financial reporting
  • Planned and implemented procedural changes to increase effectiveness and productivity
  • Reviewed trip reports and assisted in resolving conflicts
  • Responsible for ensuring monitor completes project related activities and redesigned filing structures
Candidate Info
5
years in
workforce
2
years
at this job
BA
Psychology
JD
Juris Doctor
Entertainment & Media Law Summer Program
7

Clinical Trial Assistant

Managed all start-up activities for device study, which included contract negotiation, document preparation, collecting, reviewing, and storing all regulatory documents.

  • Processed and tracked all invoice for sites and vendors, opened purchase orders
  • Coordinated regulatory process with sites to ensure all documents and procedures are completed correctly in order to meet FDA requirements
  • Created SOPs and other regulatory documents as necessary
  • Submitted protocols and other documents to Institutional Review Boards (IRB), also followed up and communicated with the IRB until protocols were approved
  • Completed file reviews for compliance and completions for in house purposes and to prepare for any FDA audits
  • Prepared administrative logs or reports in order to track site/patient data and documents
  • Prepared, handled and distributed clinical trial supplies
  • Acted as liaison for the clinical team for designated project communications, correspondence and associated documentation
Candidate Info
11
years in
workforce
2
years
at this job
BS
Political Science
MS
Public Administration
8

Clinical Trial Assistant

Provided logistical support for multiple clinical studies

  • Organized and prepared files related to study tracking, reporting and submitted to sponsor(s) TMF within established guidelines
  • Reconciled TMF on multiple clinical studies
  • Maintained and organized clinical study documents (i.e. 1572s, CVs, IRB-IEC documents such as approvals, renewals, membership list and other study agreements)
  • Prepared and submitted SAE reports and letters to opened sites
  • Maintained eRoom structure with appropriate naming convention
  • Uploaded external and internal clinical documents into eRoom database
  • Assisted CPM with site management activities such as review of monitoring reports, tracking of site visits, communication with CRAs, and other activities as assigned
  • Prepared and distributed agenda and minutes for internal team meetings
Candidate Info
17
years in
workforce
6
months
at this job
AA
Health Care Administration
BA
Health Care Administration
9

Clinical Trial Assistant

Preparation, management and distribution of clinical documentation and reports

  • Assisted with coordination and distribution of clinical trial supplies
  • Assisted with project meeting organization
  • Performed study start up document review and processing.
  • Received, processed and filed regulatory documents
  • Communicated with project teams as needed.
  • Created and distributed monthly News Letter
Candidate Info
11
years in
workforce
11
years
at this job
BA
Bachelor of Arts
MS
Health Administration
10

Clinical Trial Assistant

Assisted in selection of investigators and study sites

  • Served as a contact for sites, responding to issues and recommending corrective actions, as well as discussing recruitment issues
  • Monitoring and tracking clinical trial progress while providing status update reports
  • Participated in budget negotiations
  • Participated in the planning of investigator meetings and assisting in making presentations
  • Provided site staff education on protocol and protocol amendments
Candidate Info
3
years in
workforce
7
months
at this job
BS
Bachelor of Science

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