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Additional Medical Resume Samples
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.