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Clinical Trial Assistant Resume Samples
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0-5 years of experience
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
0-5 years of experience
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
0-5 years of experience
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.
0-5 years of experience
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
0-5 years of experience
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
0-5 years of experience
- 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
0-5 years of experience
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
0-5 years of experience
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
10+ years of experience
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
0-5 years of experience
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
0-5 years of experience
- Scanned, indexed and filed clinical trial documents.
- Assisted with system testing and validation of software upgrades.
- Updated trial databases, provided customer service, and microfilm checks.
- Checked and shelved custom created folders/backers from vendor and maintained folders.
0-5 years of experience
- Assisted document management team at [company name], a clinical trials company
- Worked with a variety of teams on several clinical trial projects
- Organized and maintained clinical trial documents according to FDA standards
0-5 years of experience
- Performed site monitoring and quality reviews of regulatory files, drug supplies, source documents, and track and process retrieved site Case Report Forms (CRFs).
- Ensured site staff are performing the clinical study according to the protocol, federal regulations, and standard operating procedures.
- Performed manual data verification as needed.
- Attended investigator meetings.
- Participated in team meetings and generate minutes from meetings as requested.
0-5 years of experience
Contacted sites to identify their possible interest in participating in up coming clinical trials.
- Collected CDAs (Confidentiality Agreements) in order to release study related information to potential sites.
- Sent and obtained feasibility questionnaires to sites to determine their qualifications to participate in studies of various indications.
- Tracked documents into database essential to creating weekly reports that ultimately decided site selection.
- Distributed status updates to appropriate project team members.
0-5 years of experience
Provided administrative support to Director and Global Trial Managers
- Responsible for calendar management for Director and Clinical Trial Manager’s
- Arranged and coordinated both international and domestic travel plans
- Archived TMF’s (Trial Master Files) in accordance with the FDA requirements
- Collected and tracked of regulatory of Clinical Trials documents
- Reviewed Financial Disclosure forms for accuracy
- Tracked non-disclosure agreements and other clinical trial documentation
- Utilized Word, Excel, Power Point, ARIBA, and e-room shared drive
0-5 years of experience
Maintained and updated site demographics on computer database; logged forms received and filed as appropriate, prepared reports from data base to include weekly reports and other reports as requested.
- Sent queries to sites and sponsor, tracked query receipt and resolution, filed communications in trial files.
- Distributed and tracked safety reports to sites.
- Assisted Clinical Research Associates in general administrative activities as requested.
- Participated in sponsor and project-related meetings and appropriately interacted with client and team.
- Processed trial specific travel arrangements and expense documents, prepared, submitted and tracked expense reports forms using appropriate financial forms and coding systems.
- Scheduled and participated in trial team meetings/sponsor meetings.
- Prepared minutes for weekly and monthly project meetings
- Assisted with training staff.
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Clinical Trial Assistant
Last edited by: Gabriela Barcenas, CONTENT STRATEGIST -
Gabriela Barcenas
CONTENT STRATEGISTGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
