Clinical Trials Assistant Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the clinical trials assistant job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

CHOOSE THE BEST TEMPLATE - Choose from 15 Leading Templates. No need to think about design details.

USE PRE-WRITTEN BULLET POINTS - Select from thousands of pre-written bullet points.

SAVE YOUR DOCUMENTS IN PDF FILES - Instantly download in PDF format or share a custom link.

Create a Resume in Minutes

L Conn

Laisha

Conn

4858 Schowalter Fords

Detroit

+1 (555) 813 8925

4858 Schowalter Fords

Detroit

Phone

p +1 (555) 813 8925

Experience Experience

Dallas, TX

Clinical Trials Assistant

Dallas, TX

Pagac, Boyer and Doyle

Dallas, TX

Clinical Trials Assistant

Meeting scheduling and logistics (including call/web conference activation, resolution of technical issues)
Acting as a central contact for the clinical team for designated project communications, correspondence and associated documentation
Tracking and management of Case Report Forms (CRFs), queries and clinical data flow
Maintaining study timelines in MS Project
Supporting CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
Copying, scanning, filing
Assist with review of clinical trial related invoices

New York, NY

Clinical Trials Assistant, Dcri

New York, NY

Krajcik, Jast and Cronin

New York, NY

Clinical Trials Assistant, Dcri

Assist with development and implementation of project-specific forms and work instructions as directed
Assist with developing, disseminating, and filing enrollment posters and newsletters
Share best practices with peers and make recommendations to trial supervisor for process improvements
Provide administrative assistance for designated project meetings as directed by trial supervisor
Perform initial review of in-coming documents for completeness, accuracy and consistency with established guidelines
Provide data entry guidance and training on trial-specific information management systems to other team members
Assist with integration of new team members

present

Los Angeles, CA

Senior Clinical Trials Assistant

Los Angeles, CA

Huels-Cronin

present

Los Angeles, CA

Senior Clinical Trials Assistant

present

Perform assigned administrative tasks to support team members with clinical trial execution
Assisting in the provision of professional and patient materials
Assist in the preparation and follow-up of company-sponsored site quality audits and regulatory authority inspections
With increasing independence, support data cleaning activities, performing data listings review, and query generation, etc
Work independently and within a team environment to meet study objectives and timelines
Adhere to CFR, GCP/ICH, company policies, Clinical Operations and project specific quality documents (e.g. SOPs, work practices, training guides)
May perform site, SMO regulatory monitoring

Education Education

Bachelor’s Degree in Life Science

Michigan State University

Bachelor’s Degree in Life Science

Skills Skills

Strong attention to detail
Good written and verbal communication skills in Finnish language including good command of English language
Attention to detail and the ability to prioritize
Good written and verbal communication skills including good command of English language
Very good 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 and Dutch language
Ability to establish and maintain effective working relationships with co-workers, managers and clients
 Ability to establish and maintain effective working relationships with coworkers, managers and clients
Strong communication skills
Polished and professional demeanor

Create a Resume in Minutes

11 Clinical Trials Assistant resume templates

Read our complete resume writing guides

Clinical Trials Assistant Resume Examples & Samples

Bachelor's Degree in Biological Sciences
Demonstrable leadership skills $
Prior experience in the pharmaceutical industry

Clinical Trials Assistant Resume Examples & Samples

Associate's Degree or comparable work experience in similar role
Experience in CTMS Systems and document scanning and archiving
Microsoft Office/Suite proficient(Excel, PowerPoint, etc.)
SharePoint experience
Experience in Clinical Research / Regulatory processes, including FDA IND regulatory requirements

Clinical Trials Assistant Resume Examples & Samples

Perform a variety of research, data base and clerical duties of a complex and technical nature in support of multi-center clinical trials to assist investigators in organizing, gathering and compiling clinical research data
Maintain and update site demographics on computer data base
Log forms received and file as appropriate
Prepare reports from data base to include weekly reports and other reports as requested
Supervise the receipt and dissemination of study related regulatory documents and correspondence from assigned sites
Screen documents for completeness and compliance with protocol and appropriate regulations; investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of data
Maintain ongoing communications with sites to provide information,track documentation and overall progress of clinical trials and adherence to established guidelines
Ensure that study materials and drug kits are shipped and resupplied as requested
Respond to questions related to study protocol independently or refer to others as appropriate
Document all conversations in the data base
Assist Clinical Trials Coordinators in general administrative activities as requested to include, but not limited to, providing input on adverse trends or problems noted and/or input regarding study modifications, development of Standard Operating Procedures for clinical trials and revision of data collection forms and worksheets
Discuss unusual requests or indications that a site is not in compliance with established guidelines
Communicate regularly with regional data monitors as needed to provide information before and after visits to participating sites
Review the monitor's post visit reports and follow up on problems identified as appropriate
Communicate and coordinate with other study personnel as required to include data entry and randomization personnel, pharmacy, laboratories, study sponsors and others as needed for study implementation and problem resolution
Attend routine weekly meetings and other meetings related to the clinical trial
Stay abreast of information and any changes to study protocol
Perform other related duties incidental to the work described herein

Clinical Trials Assistant, Dcri Resume Examples & Samples

Manage information with some guidance for site, project, and team activities in established systems and spreadsheets according to applicable SOPs, guidelines, and study specific-requirements
Track dissemination, receipt and approval status of study-related documents. Maintain investigator database with all required information for assigned clinical trial sites
Collect and track required site information and documents prior to shipment of regulatory packet and study materials
Maintain required paper and electronic documents for investigator and regulatory files according to SOPs and study-specific requirements
Prepare and disseminate status reports on regulatory documents, patient enrollment, and data activities for assigned sites
Notify designated contacts for site activation and shipment of study supplies as directed. Provide follow up as directed
Assist with development, compilation, dissemination, collection, tracking and report generation of regulatory and other essential trial documents with some guidance
Develop and edit spreadsheets and tools as directed
Receive and collect required documents prior to shipment of regulatory packets. Prepare, send, and track out-going regulatory packets. Promptly collect and accurately track all versions of in-coming documents and communications
Perform initial review of in-coming documents for completeness, accuracy and consistency with established guidelines
Maintain accurate and complete regulatory and investigator files according to SOPs and established trial-specific guidelines
Distribute safety reports to sites and track as directed
Generate and distribute standard study reports
Assist with preparation of study files for audits
Maintain security of electronic and paper study documents throughout all work activities
Support clinical operations team members through communication with sites, collection and entry of current site status into systems prior to site visits and meetings, regular updates to teammates and trial supervisors, and other project activities with some guidance
Assist monitors with preparation and follow-up activities associated with all types of monitoring visits by providing current subject status reports, site status reports, and other related pre- and post-visit support
Process study supply request forms from sites, order study supplies, enter study supply requests and shipment data into tracking system and generate reports
Assist with in-house site evaluation, source document collection and close-out activities as directed
Assist with routine review and upkeep of site and project files to maintain complete and current versions of all essential documents
Assist with completion, submission and tracking of expense report forms using appropriate financial forms, coding systems, and organizational and trial-specific guidelines
Provide regular updates to trial supervisor and project team without prompting
Provide data entry guidance and training on trial-specific information management systems to other team members
Achieve objectives for independent projects as directed by supervisor
Assist with integration of new team members
Assist with development and implementation of project-specific forms and work instructions as directed
Assist with the collection and tracking of completed data forms, data queries and source documents as directed
Send queries to sites as directed, assist with routine query resolution, track query receipt and resolution, and file communications and resolutions in trial files
Review data submission status reports to identify late or missing data for assigned sites
Follow up with site personnel to collect outstanding data and provide site education and reinforcement as directed
Assist with requests, collection, and tracking of source documents for assigned sites
Provide administrative assistance for designated project meetings as directed by trial supervisor
Assist with meeting preparations, generation and distribution of minutes, and filing specified information for designated project meetings
Assist in compiling and assembling packets for investigator meetings, study-related meetings and national conventions
Attend and support regular trial team meetings and other internal meetings as directed
Assist with travel arrangements and other trip preparations related to various professional activities
Share best practices with peers and make recommendations to trial supervisor for process improvements
Assist with routine site communication. Communicate and coordinate with other study personnel to support flow of information and trial activities with some guidance
Communicate with sites to assist with routine study questions in an assertive, business-like manner which fosters cooperation
Assist sites with essential document completion and revision; follow up on missing and incomplete documents
Assist with developing, disseminating, and filing enrollment posters and newsletters
Communicate with sites to determine adequacy of study materials and supplies
Communicate with other departments as directed to facilitate trial activities

Clinical Trials Assistant Resume Examples & Samples

Assist with the creation and maintenance of documents and plans for assigned clinical studies including but not limited to training materials, study binders, plans, presentations, and reports
Establish and maintain the CTMF and CTMS. Under the supervision of the PL and/or CPM, review the CTMF/S for compliance. Produce reports and status metrics as requested
Communicate directly with sites and CRAs to obtain Essential Documents
Schedule/set-up/open meetings, telecons, and Web/Ex. Prepare meeting agendas, minutes, and track action items as assigned
Maintain and distribute up-to-date site, vendor and study contact information
Ensure timely distribution of clinical trial related materials to sites, study team, CRAs and vendors
Under supervision of the PL, may assist with data cleaning activities such as CRF review, listings production and review, and query generation
Assist in preparation and follow-up of company-sponsored site quality audits as well as regulatory authority inspections
Assist with investigational product distribution and study-wide accountability
Assist with review of clinical trial related invoices
Assist with reconciliation of planned versus actual visits as related to site payments
BS/BA or equivalent preferred and a minimum of 1 year clinical trial experience, preferably within the pharmaceutical or biotechnology industry
Basic knowledge and understanding of CFR and GCP/ICH
Proficiency with Microsoft Office Products–Word, Excel, PowerPoint, SharePoint (preferred)
Fundamental understanding of filing systems and organizational tools
Able to multi-task and prioritize work under limited direction and on own initiative
Highly responsive and proactive, a team player

Senior Clinical Trials Assistant Resume Examples & Samples

Initiate and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training materials, study binders, plans, study registration and other process descriptions, presentations, and reports
Establish and maintain the CTMF and CTMS. Under supervision of the PL and/or CPM review the CTMF/S for compliance, addressing findings as needed and supporting the study team with study activities. Produce reports and status metrics as requested
Communicate directly with sites, Site Management Organizations, Contract Research Organizations and field CRAs to obtain updated information, Essential Documents, etc. to assist with driving start up, study conduct, and/or close out activities
Coordinate meetings/telecons/ Web/Ex. Prepare agendas, minutes, and track action items
Distribute clinical trial related materials to sites, study team, CRAs and vendors
With increasing independence, support data cleaning activities, performing data listings review, and query generation, etc
Under supervision of the PL review Informed Consent documents and regulatory documents
Increase basic knowledge of scientific, medical and therapeutic information
Assist in the preparation and follow-up of company-sponsored site quality audits and regulatory authority inspections
May perform site, SMO regulatory monitoring
Adhere to CFR, GCP/ICH, company policies, Clinical Operations and project specific quality documents (e.g. SOPs, work practices, training guides)

Clinical Trials Assistant Resume Examples & Samples

Assist the clinical team in 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 for completeness
Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
High or Secondary School diploma/certificate or country’s educational equivalent and 3 years administrative support experience; or equivalent combination of education, training and experience

Senior Clinical Trials Assistant Resume Examples & Samples

Assume responsibility for completing assigned tasks in a timely manner, requiring minimal ongoing direction and supervision
Provide senior level support in the preparation, handling, distribution, filing and archiving of clinical documentation, and assisting with periodic file audits
Assume responsibility for processing study supply requests from internal and external contacts, and the shipping and tracking of all study supply shipments
Coordinate and manage the assembly, tracking, maintenance and distribution of lab kits
Contribute to, and participate in, study dry runs, pre-study planning activities, departmental and project specific meetings; ability to take, finalize and file meeting minutes
Function as the central Clinical Affairs contact for department wide communications and events
Responsible for remaining current with all applicable departmental and corporate SOPs (standard operating procedures), WI (work instructions) and procedures
Demonstrate commitment to the implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies
Perform other duties & projects as assigned
A minimum of 3-4 years’ experience in clinical research or a related field, with particular skills and knowledge of clinical study activities
Strong attention to detail and the ability to QC own work
Ability to balance conflicting priorities and manage multiple projects and timelines
Ability to safely handle and work with human specimens including blood, blood related products and urine

Senior Clinical Trials Assistant Resume Examples & Samples

BS/BA or equivalent or minimum 2 years clinical trial experience within the pharmaceutical or biotechnology industry
Basic knowledge and understanding of CFR and GCP/ICH required
Proficiency Microsoft Office Products—Word, Excel, PowerPoint, SharePoint (preferred) Proficiency with filing systems and organizational tools
Able to multi-task under limited direction and on own initiative
Able to recommend and implement process improvements

Clinical Trials Assistant Resume Examples & Samples

Prepare, track, and ship study start-up packets to clinical sites
Prepare, track, and ship site initiation visit materials, ensuring version control for documents
Manage study supply inventory
Update contact information ensuring accuracy
Data entry for tracking of documents
Prepare clinical documents for filing
Assist with meeting preparations and binder assembly
Mass mailing distributions
Copying, scanning, filing
Support to field Clinical Operations personnel
Coordinate special projects as needed
Schedule meetings
Minimum 1-2 years of clinical study start-up experience
Requires a high school diploma with two or more years of college with math/science courses preferred. Minimum of two year’s previous office experience or equivalent combination of education and work experience. Knowledge of the biotech/pharmaceutical/healthcare industry preferred
BS in life science preferred
MS Word, Excel, in-depth knowledge of other presentation programs a plus
Attention to detail and the ability to prioritize
Ability to work independently as well as within teams
Self-direction and motivation are mandatory
Typical office hours

Clinical Trials Assistant Resume Examples & Samples

Assisting Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
Assisting the clinical team in 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 for completeness
Supporting CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
Tracking and management of Case Report Forms (CRFs), queries and clinical data flow
Acting as a central contact for the clinical team for designated project communications, correspondence and associated documentation

Senior Clinical Trials Assistant Resume Examples & Samples

Coordinate, prepare, review and track documents for the application process
Interface with investigators, external service providers and CRAs during the collection process
Main contact for CRAs and the Study leaders during study team meetings, monitor meetings and investigator meetings until finalization of the study
Ensure payments are made in compliance to regulation and paid in a timely manner
Set-up, populate and maintain information in tracking communication tools, and support with usage of the systems in each study
Set-up the local Trial Master File (eTMF) with reviewing, approving and uploading of documents following the ICH/GCP compliance and local requirements and support CRA in ISF activities
Maintain study documents by localizing templates with version compliance
Contribute to applications and submissions for effective publishing and delivery to regulatory authorities, such as, local ethics committees and the MHRA
Create and import clinical-regulatory documents into the Global Electronic Library (GEL)
Assisting in the provision of professional and patient materials
Manage initial set up and access requests for trial site staff to various study systems
Tracking patient recruitment, withdrawal and sample collection

Clinical Trials Assistant Resume Examples & Samples

Assist Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
Assist CRAs/iCRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
Very good written and verbal communication skills in Dutch and in French, including good command of English language
Bachelor/Master in life science related study program or country’s educational equivalent and administrative support experience; or equivalent combination of education, training and experience

Clinical Trials Assistant Resume Examples & Samples

Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintainingclinical systems that track site compliance and performance within project timelines
Assist the clinical team in 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 for accuracy and completeness
Assist CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
Provide administrative support to team members with clinical trial execution

Senior Clinical Trials Assistant Resume Examples & Samples

Establish and maintain the CTMF and CTMS.Under supervision of the PL and/or CPM review the CTMF/S for compliance, addressing findings as needed and supporting the study team with study activities. Produce reports and status metrics as requested
Coordinate meetings/telecoms/ Web/Ex. Prepare agendas, minutes, and track action items
Assist in the preparation and follow-up of company-sponsored site quality audits and regulatory authority inspections. May perform site, SMO regulatory monitoring

Clinical Trials Assistant Resume Examples & Samples

Assist in the generation, receipt and filing of required study documentation, including but not limited to study logs, study binders, and regulatory documents according to applicable SOPs
Assist with screening potential study sites, coordinating site questionnaires, and compiling site data for review by the clinical study lead or designee
Prepare and send CDAs, and other study related materials to clinical study sites. Follow up on regulatory approval (IRB/Ethics Committee) status
Coordinate compliant shipments of biological samples, investigational devices and other applicable study supplies
Inventory, ship, track and log all supplies and devices in support of clinical studies. Facilitate final accountability of all clinical supplies and devices
Inventory the receipt of biological samples and populate a database to track the disposition of samples
Coordinate in-house blood draws and internal sample collection studies. Maintain internal sample study administration in accordance with IRB requirements, HIPAA privacy and all applicable regulations
Maintain clinical study activities in spreadsheet templates, consistent with company timelines and objectives
Construct in-house and study site clinical files
Support all clinical affairs activities as needed

Clinical Trials Assistant Resume Examples & Samples

Bachelor's degree (or advanced student) in a health care or other scientific discipline
6 – 18 months clinical research experience, or equivalent combination of education, training and experience
Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Strong therapeutic and protocol knowledge as provided in company training
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
Strong organizational and problem-solving skills

Clinical Trials Assistant Resume Examples & Samples

 Assist Clinical Research Specialist (CRS)/In-house Clinical Research Specialist (iCRS), Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
 Assist the clinical team in 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 for completeness
 Assist CRS/iCRS, CRAs/iCRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
 Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
 Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
 May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval
 May perform assigned administrative tasks to support team members with clinical trial execution
 Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
 Knowledge of applicable protocol requirements as provided in company training
 Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
 Good written and verbal communication skills including good command of English and Dutch language
 Effective time management and organizational skills
 High or Secondary School diploma/certificate or country’s educational equivalent and 3 years administrative support experience; or equivalent combination of education, training and experience

Senior Clinical Trials Assistant Resume Examples & Samples

Coordinate meetings/telecoms/ WebEx. Prepare agendas, minutes, and track action items
Proficiency Microsoft Office Products—Word, Excel, PowerPoint, SharePoint (preferred)
Proficiency with filing systems and organizational tools

Clinical Trials Assistant Resume Examples & Samples

Work independently and within a team environment to meet study objectives and timelines
Provide in-house support in the preparation, handling, distribution, filing and archiving of clinical documentation, and assisting with periodic file audits
Responsible for completing assigned tasks in a timely manner, requiring minimal ongoing direction
Assist study teams by coordinating the ordering, tracking, and accountability of clinical supplies, including investigational product materials, equipment, and special-order items as requested
Coordinate with the clinical trial managers (CTM) and all other Clinical team members on the planning of study supplies needs (i.e., lab supplies, barcodes, binders, etc) and placing orders
Assist CRAs in processing study supply requests from internal and external contacts, and the shipping and tracking of all study supply shipments
Organize and arrange department wide communications, meetings and events
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
A minimum of 0-2 years’ experience in clinical research or a related field, with particular skills and knowledge of biotech activities preferred
Demonstrated computer skills including proficiency with Microsoftâ Office programs: Outlook, Word, Excel and PowerPoint
Ability to apply training and knowledge to every day work load
Demonstrated ability to foster and maintain effective working relationships with co-workers and project team members and, demonstrated professionalism with all internal and external contacts
Ability to balance priorities and manage expectations

Clinical Trials Assistant Resume Examples & Samples

Degree in Healthcare career
1-year experienced in Clinical Research environment
Upper Intermediate Level of English language
Ability to establish and maintain Effective working relationships with coworkers, managers and clients

Clinical Trials Assistant Resume Examples & Samples

Establish and maintain the CTMF and CTMS.Under the supervision of the PL and/or CPM, review the CTMF/S for compliance. Produce reports and status metrics as requested
Schedule/set-up/open meetings, telecoms, and Web/Ex. Prepare meeting agendas, minutes, and track action items as assigned
Ensure timely distribution of clinical trial related materials to sites, study team, CRAs and vendor

Clinical Trials Assistant Resume Examples & Samples

Meeting scheduling and logistics (including call/web conference activation, resolution of technical issues)
Distribution of agendas and generation of meeting minutes
Study file maintenance (electronic and/or hard copy)
Document tracking and signature/approval follow-up, where applicable (including Confidential Disclosure Agreements (CDAs), contracts, proposals, payments, invoices, and other study documentation required in the study file)
Creating and maintaining study/project contact lists and tracking tools for budget, enrollment, samples, site supplies, and other study specific needs
Maintaining study timelines in MS Project
Study Regulatory Binder design, development, production and distribution (including study specific form creation)
Microsoft Office support for study, program, and department documents (Word, Excel and PowerPoint)
Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions
Other duties and project support as assigned
General administrative support to the Clinical Project Teams
Assist project teams with study specific tasks

Senior Clinical Trials Assistant Resume Examples & Samples

Assist Clinical Research Specialist (CRS)/In-house Clinical Research Specialist (iCRS), Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
Collaborate with Clinical Project Manager (CPM), CRS/iCRS, 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
Collaborate with CRS/iCRS, CRAs/iCRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
Perform assigned administrative tasks to support team members with clinical trial execution
Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

Clinical Trials Assistant Resume Examples & Samples

Enter and maintain current data in clinical systems (i.e., enrollment as requested, EDC access maintenance, etc.)
Coordinate printing of Investigator Study File (ISF) and other study materials and distribution to the sites at study start and as needed during the study
Review proof copy of study material and coordinate correction of errors prior to printing complete package
Assist with preparation of training material
Assist with compliance review of clinical documentation as requested by CTDM
Coordinate test article reconciliation and resolution of issues with LCSM
Assist Site Development as requested by manager

Download Clinical Trials Assistant Resume Sample as Image file