Clinical Trials Assistant Resume Sample
Hal Steuber
155 Mona Flats,
Boston,
MA
+1 (555) 642 8786
Work Experience
Senior Clinical Trials Assistant
10/2015
-
PRESENT
Houston, TX
- Maintain ongoing communications with sites to provide information, track documentation and overall progress of clinical trials and adherence to established guidelines
- Maintain a working understanding of current applicable regulations, SOPs, WI and guidance documents, such as FDA Code of Federal Regulations (CFR), ICH Guidelines on Good Clinical Practices (GCP), and Alere’s Quality System
- Exhibit professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices
- Assist with information management for site, project, and team activities in established systems and spreadsheets with guidance according to applicable SOPs, guidelines, and study specific-requirements
- Assist with periodic review of study files for accuracy and completeness
- Relevant work experience in health care, biotechnology or diagnostics
- Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook, and Project)
Clinical Trials Assistant
02/2011
-
08/2015
New York, NY
- Support study start up, conduct and/or close out activities by communicating directly with sites, Site Management Organizations, Contract Research Organizations, central labs, and field CRAs to obtain, review and process Essential Documents independently
- Coordinate meetings, telecons, and Web/Ex. Prepare agendas, minutes, and track action items
- Ensure timely distribution of clinical trial related materials to sites, study team, field CRAs and vendors
- With increasing independence, support data cleaning activities, performing data listings review, and query generation
- With increasing independence, review Informed Consent documents
- Adhere to CFR, GCP/ICH, company policies, Clinical Development Operations and project specific quality documents (e.g. SOPs, work practices, training guides)
- Support CTLs by setting up and maintaining appropriate study tracking forms including: enrollment log/trial allocations forms, site and vendor contact lists, drug shipping logs, set up and maintenance of team membership and contact lists
- Provide vendor and budgets tracking and support. Manage and track US invoices for third party vendors
- Set up and maintain eTMF tracker in CREDI for all studies. Provide support to CTL to ensure timely completion of eTMF tracker for CSR
Clinical Trials Assistant
08/2008
-
01/2011
New York, NY
- Excellent oral and written communication skills, and strong organizational abilities
- Advanced skills in Microsoft Office to include Word, Excel, Powerpoint
- Excellent organization skills with exceptional attention to detail
- Assist Clinical Research Associates and Regulatory Study Start-Up with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
- Assist the clinical team in the preparation, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
- Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
- Act as a central contact for the team for designated project communications, correspondence and associated documentation
- Establish and maintain the eTMF/TMF and CTMS. Under supervision of the PL and/or CPM, review files/systems for compliance, addressing findings as needed and supporting the study team with study activities. Produce reports and status metrics as requested
Education
Upper Iowa University
2003 - 2008
Bachelor's Degree in Life Science
Professional Skills
- Strong Computer skills including proficiency in use of Microsoft Word Excel and PowerPoint
- Fluent written and verbal Danish communication skills including good command of English language
- Clinical research experience, or equivalent combination of education, training and experience
- Computer skills using database programs e.g. Excel, Access, Word
- Fluent written and verbal communication skills in Dutch and in French, including good command of English language
- Good written and verbal communication skills including good command of English language
- Good written and verbal communication skills including good command of Dutch and English language (required)
How to write Clinical Trials Assistant Resume
Clinical Trials Assistant role is responsible for english, clinical, research, command, microsoft, database, word, excel, powerpoint, organization.
To write great resume for clinical trials assistant job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Trials Assistant Resume
The section contact information is important in your clinical trials assistant resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Clinical Trials Assistant Resume
The section work experience is an essential part of your clinical trials assistant resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous clinical trials assistant responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular clinical trials assistant position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Trials Assistant resume experience can include:
- Support CTL in delegated aspects of trial data analysis and reporting, including attendance at all relevant study meetings (i.e. CTT and dose escalation meetings). Provide support in meeting scheduling and distribution of meeting agendas/minutes
- Scheduling of patient/research participants
- Working with the CSMs/CCSA, develop and maintain operational templates/tools based on the needs of assigned studies/tasks or processes
- Assist with data monitoring such as tracking/filing of protocol deviations, generating data listings and database metrics
- Support the Lead CTL and CTLs for imaging tracking and act as a liaison with sites for imaging deliverables, image reconciliation and associated logistics
- Assist in the planning, organizing and executing project-specific meetings
Education on a Clinical Trials Assistant Resume
Make sure to make education a priority on your clinical trials assistant resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical trials assistant experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Clinical Trials Assistant Resume
When listing skills on your clinical trials assistant resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical clinical trials assistant skills:
- Effective time management and good ability to manage competing priorities
- Experience with clinical study planning, execution, reporting or publishing activities
- Clinical experience in an academic hospital setting
- Packaging and lifting supplies for storage and shipping
- Supporting system end users and maintaining database applications; and
- Presenting to internal and external customers as required
List of Typical Experience For a Clinical Trials Assistant Resume
1
Experience For Senior Clinical Trials Assistant Resume
- Knowledge of applicable protocol requirements (as provided in company training)
- Assist with/Distribute Safety Reports to all sites, and internal NBI staff
- Establish collaborative relationships with colleagues in Clinical Development, Regulatory Affairs, Data Management and throughout the Company
- Location is San Francisco, CA Office
- Life Sciences Student
- 13 October 2016
- 09 Dec 2016
List of Typical Skills For a Clinical Trials Assistant Resume
1
Skills For Senior Clinical Trials Assistant Resume
- Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical
- Participating in planning, initiation, and reporting of clinical trials according to company procedures and international regulations
- Managing Clinical Trial Supplies logistics, including coordinating local secure destruction
- Mentor and assist with training of incoming CTAs
- Extensive keyboarding involving repetitive motions with fingers
- Support Lead CTL and CTLs for tracking molecular screening samples and data as required
- Prepare, handle and distribute of Clinical Trial Materials and maintenance of tracking information
- Assist Clinical Trial Management to ensure accurate, timely, and coordinated availability of clinical trial materials and documents
- Awareness of knowledge of applicable clinical research regulatory requirements; i.e.,Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
2
Skills For Clinical Trials Assistant, Dcri Resume
- Upper Intermediate Level of English language (mandatory)
- Life Sciences Student (preferably but not exclusive)
- Meticulous and able to work in a fast-paced environment
- Organizational skills and the ability to get along with people would be essential. Ability to work independently and proactively in a large, busy hospital setting
- A general knowledge of applicable clinical research regulatory requirements; including GCP and ICH guidelines
3
Skills For Clinical Trials Assistant Resume
- Exelente habilidade de organização e atenção a detalhes
- Boa comunicação oral e escrita
- Extensive use of telephone and face-to-face interactions, which require accurate perception of speech
- Accurately update and maintain clinical systems within project timelines
- Prepare, handle, distribute, file, and archive clinical documentation and reports; review of study files periodically for accuracy and completeness
- Track and manage Case Report Forms (CRFs), queries and clinical data flow
4
Skills For Senior Clinical Trials Assistant Resume
- Performing general administration including filing, organising mail and couriers, invoice processing, document preparation and set-up and maintenance of files (electronic and paper)
- Assist CTL with preparation and distribution of study tools needed at study start up and throughout trial as appropriate
- Support the Lead CTL and CTLs for both PK and biomarker sample tracking in collaboration with the Clinical IT Specialist and act as a liaison with sites for sample shipment, sample reconciliation and associated logistics
- Execution of high quality programs within budget and timelines from the support perspective
- Accurate maintenance of trackers and databases to ensure key metrics and status of studies
- Transmits and distributes protocol information, including protocol amendments, to clinicians, technicians and other involved personnel. Serve as a source for protocol and clinical research information about the projects
- Assists with samples collection, including blood and urine collection and animal restraint for sample collection
- Assists other personnel in verifying patient eligibility for Oncology studies by comparing patient history and clinical laboratory results with protocol requirements. Ensures that patients are registered in appropriate databases and that all relevant data points are captured
5
Skills For Clinical Trials Assistant, Dcri Resume
- Assist the Clinical Trials Coordinator in creating and maintaining databases, spreadsheets and research charts
- Regularly compiles and/or reviews research data to insure the completeness, accuracy and timeliness of data collected. Meets regularly with Clinical Trials Research Coordinator/PI to review data accuracy and overall study progress
- Assist in preparing reports on individual patients or the study as required by the principal investigator
- Prepares for and participates in audits of studies, both by internal and external parties in conjunction with the principal investigator
- Under the direction of the principal investigator, prepares new study requests and protocol/consent modifications to be sent to the IACUC and VHHRC
6
Skills For Clinical Trials Assistant Resume
- Assists with the annual protocol renewal requests and termination reports for the principal investigator
- Assist with study planning, budgeting and grant preparation. Schedules and coordinates meetings and facilities for research teams to facilitate clinical trial initiation, completion and/or results reporting. Composes research correspondence, memos, reports and minutes of research meetings
- Supporting finance processes associated with investigator site payments
- Awareness of knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- Collaborate with Clinical Project Manager (CPM), CRAs/iCRAs and RSU on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files and completeness
- Contribute to study team meetings by providing study updates and writing meeting minutes
- Collaborate with CRAs/iCRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
7
Skills For Senior Clinical Trials Assistant Resume
- Regularly compiles and/or reviews research data to insure the completeness, accuracy and timeliness of data collected.Meets regularly with Clinical Trials Research Coordinator/PI to review data accuracy and overall study progress.
- Under the direction of the principal investigator, prepares new study requests and protocol/consent modifications to be sent to the IACUC and VHHRC. Assists with the annual protocol renewal requests and termination reports for the principal investigator
- Support CSMs/CCSA by ensuring trial tracking systems and tools are updated so they comply with regulations, internal policies and ICH -GCP, when applicable
- Assist with the review and tracking of safety procedures to ensure they are being followed, escalated and resolved as necessary
- Support management of the secure document exchange and SUSAR reporting process during the conduct of the study, as required
- Perform monitoring and co-monitoring visits, as necessary
- Support local study teams by providing study reports and trackers (e.g. regulatory/ethics approvals), as required
- Manage shared study areas (e.g. TouchPoint), according to Roche standards
- Support Study Manager/Director by independently performing assigned clinical operations tasks from study start-up through study execution and closeout
8
Skills For Clinical Trials Assistant, Dcri Resume
- Develop and maintain/oversee study tracking reports and study tools
- Track enrollment and follow up on outstanding information
- Oversee study tracking to ensure documents are accurate, current and complete
- Assist with overseeing tasks performed by Clinical Trial Assistant(s)
- Support document management, quality review checks and completion of country-level Trial Master File(TMF)
- Order study-related supplies, as delegated by the role supported, and as required
9
Skills For Clinical Trials Assistant Resume
- Support CSMs/CCSA on startup activities
- In collaboration with the CSMs/CSSs, coordinate local investigator and local study team meetings and departmental project/portfolio meetings, where required
- Provide required local customs documentation to meet country requirements for importation/exportation, as applicable
- Support management of investigator, site and providers payments, if applicable
- Associates based in TCO Shanghai, support local CTA submission including validation of translation of protocols, amendments, ICFs, IBs etc. for TCO trials with sites in China
- Assist Clinical Research Associates (CRAs) and Regulatory-Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
- Assist with finance activities related to invoices, payment handling
10
Skills For Senior Clinical Trials Assistant Resume
- Participate in vendor management/oversight
- Assist with resolution and communication of investigational site Protocol Deviation Forms
- Establish collaborative relationships with colleagues in Clinical Development, Regulatory Affairs and throughout the Company
- Assist study teams with all aspects of the clinical trial (from start-up to closeout) for assigned studies
- Create and Maintain Study Status Documents (e.g.: contact lists, enrollment, CRA Travel Schedule, CRA Site Assignments and Visit Reports)
- Prepare and distribute Regulatory Binders, Study Reference Manuals and other study supplies to sites
- Schedule and set up study team and vendor meetings
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