Clinical Trial Assistant Resume Samples

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S Lebsack

Sandrine

Lebsack

345 McDermott Meadows

New York

+1 (555) 552 3166

345 McDermott Meadows

New York

Phone

p +1 (555) 552 3166

Experience Experience

Detroit, MI

Clinical Trial Assistant

Detroit, MI

Dibbert-Wolff

Detroit, MI

Clinical Trial Assistant

Serve as part of the Project Team and work on cross functional teams on the implementation and management of client projects
Assist with site management, initiating collection, reviewing and tracking of essential documents
Assist with project and site level set up in the Clinical Trial Management System
Assist the clinical team with updating and maintaining clinical systems that track site compliance and performance within project timelines
Assist project managers, LCRA’s and CRA’s with mailings to sites, faxes, regulatory documents
Facilitate/track site shipments and assist with sample handling and management
Liaise with partners, vendors and support groups such as ancillary supplies management, and establish good communication lines with various departments

Detroit, MI

Temp-clinical Trial Assistant

Detroit, MI

Wehner, Zemlak and Ullrich

Detroit, MI

Temp-clinical Trial Assistant

Assists with vendor management
Assists with reviewing monitoring visit reports
Applies knowledge of company policies and standard practices to resolve problems
Participates in tracking and reporting study data for management reports
Assists CSTL or other study team members with requesting, collecting, and reviewing site regulatory documents
Assists with study specific document writing and review – (Protocols, ICFs, Source Docs, etc)
Assists in the writing, collection, distribution and filing of meeting agenda and meeting minutes

present

San Francisco, CA

Clinical Trial Assistant, Role Will be Based

San Francisco, CA

Auer-Kutch

present

San Francisco, CA

Clinical Trial Assistant, Role Will be Based

present

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 with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
Assist CRS/iCRS, CRAs/iCRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
May perform assigned administrative tasks to support team members with clinical trial execution
Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
Assist project managers and CRA’s with developing/printing TMF binders

Education Education

Bachelor’s Degree in Life Sciences

Arizona State University

Bachelor’s Degree in Life Sciences

Skills Skills

Strong attention to detail
Strong written and verbal communication skills including good command of English language
Good written and verbal communication skills including good command of English language
Demonstrated ability to work independently with exceptional organization and attention to detail
Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA) specifically for FDA and EMA
Participate in review of all supporting documents for a clinical study – Protocols, Statistical Analysis Plans, CRFs, Data Management Plans, Clinical Study Reports, etc
Ensures adherence to standard operating procedures, good clinical practice, and FDA regulations with strong understanding of inspection readiness
Tracks study status, enrollment, regulatory documentation, and site start‐up status for assigned clinical projects including review and approval of regulatory package for release of clinical supply
Clinical study team member: works closely with the Study Manager and Clinical Project Manager and is responsible for coordination, tracking, and management of logistics in support of clinical trials
Fluent in Good Clinical Practice (GCP) and is able insure implementation within any clinical study

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Clinical Trial Assistant Resume Examples & Samples

Set-up, maintenance and archiving of trial master files
Update and maintenance of clinical trial systems
Creation and maintenance of study manuals
Compiling regulatory submission documents
Creation and maintenance of study-related tracking documents
Acquisition and distribution of clinical trial related materials
Assist with QC of key documents such as ICF, protocols, manuscripts and study reports
General assistance with study logistics as required
Prior experience in a clinical operations environment, within the pharmaceutical industry is preferred
Good working knowledge of ICH-GCP is preferred
Good written and verbal communication skills are required
A minimum of a Bachelor’s degree in Life sciences is required
Strong computer skills, proficient with Microsoft office programs (Word, Excel, PowerPoint, Outlook) are required
The ability to multi-task, prioritize, and work collaboratively in a highly confidential environment is required
The ability to adapt to the demands of a fast paced environment is requiredClinical Research non-MD

Clinical Trial Assistant Resume Examples & Samples

Exhibit general computer literacy, spreadsheet software competency and good typing skills
Ideally previous experience working with Essential Documents in Clinical Trials
University/college degree graduates in any of the life sciences, or with a certification in a related allied health profession from an appropriately accredited institution

Clinical Trial Assistant Resume Examples & Samples

Provide technical support by tracking and reporting of trial budgets, invoices, and related financial documentation activities (e.g. purchase orders)
Organize and maintain both paper and electronic Trial Master Files (eTMF) and assist with eTMF administrative support activities
Provide technical support by tracking ancillary clinical supplies and other trial-related documents and materials
Perform and/or maintain data entry in internal Quality systems (e.g. Veeva Vault)
Assist in communication with investigative sites and external vendors (e.g. Central Lab)
Assist in the preparation of trial updates and presentations
Assist in internal meetings by distributing agenda and minutes
Coordinates and provides technical oversight for both internal/external meetings (e.g. WebEx)

Clinical Trial Assistant Resume Examples & Samples

Responsible for reconciliation of monthly invoices/PO management. Also responsible for investigator and vendor payments for in-house studies
Work directly with study managers to ensure milestones are completed for invoiced items
Tracking of invoices received and approval signatures
Reconciliation of expenses and site payments
Protocol review to ensure seamless integration between clinical objectives and study performance
Participate in CRO review, selection, and negotiation for each study
Participate in review of all supporting documents for a clinical study – Protocols, Statistical Analysis Plans, CRFs, Data Management Plans, Clinical Study Reports, etc
Works closely with Study Manager and legal to review and approve confidentiality agreement, clinical trial agreements and site specific study budgets
Tracks study status, enrollment, regulatory documentation, and site start‐up status for assigned clinical projects including review and approval of regulatory package for release of clinical supply
Responsible for set‐up, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files along with internal working file, as needed.Coordinates TMF transfer with CROs
BA/BS preferably in nursing, biology, biochemistry, or related areas is preferred but not required
2 years of experience in clinical research operations preferred
Experience supporting one or more clinical studies in the following therapy areas is desirable: anemia, chronic kidney disease, dialysis, and/or oncology
Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA) specifically for FDA and EMA
Demonstrated ability to work independently with exceptional organization and attention to detail

Clinical Trial Assistant Resume Examples & Samples

Excellent English and Spanish language skills
Working skills across all of the Microsoft packages
Two years experience in a similar role (CTA or Project Coordinator)
Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency
Strong interpersonal skills and high attention for detail, with proven ability to handle multiple tasks efficiently and effectively

Clinical Trial Assistant Supervisor Resume Examples & Samples

Contacting external and internal individuals; you will collate relevant study information and assist with study payments. You should be prepared to take on any additional tasks assigned as and when required
Around 5 years of Clinical Administrative support experience, ideally as a CTA
Desirable previous direct report experience

Clinical Trial Assistant Resume Examples & Samples

Assist the clinical teams with accurately updating and maintaining clinical systems that track compliance and performance within project timelines and budget
Assist the clinical teams in the preparation, handling, distribution, filing, and archiving of clinical documentation, tools, templates and reports according to the scope of work, international regulations and guidelines, and standard operating procedures
Assist with periodic review of study files for completeness
Perform assigned administrative tasks to support clinical team members with clinical trial execution
Ensure detailed corresponding reports and administration
Actively contribute to result oriented department goals
Liaise with partners, vendors and support groups such as ancillary supplies management, and establish good communication lines with various departments
Provide assistance in preparation, conduct and documentation of internal, external, investigator, vendor or country operations meetings: practical arrangements, presentations, minutes.
Life sciences degree, or relevant work experience in clinical research field
Meticulous and efficient with strong emphasis on accuracy, and good with administrative tasks
Excellent computer skills including working knowledge of Microsoft Word, Excel, PowerPoint, Outlook and Microsoft Project
Good written and verbal communication skills including good command of English and Dutch language
Effective time management and strong organizational skills
Ability to establish and maintain effective working relationships with coworkers, managers, partners, vendors and other third parties as needed
Interpersonal skills and ability to work in a team environment
Good understanding of the clinical research processes, the ICH/GCP (international good clinical practice guidelines and harmonization)
Knowledge of national and international clinical trial regulations (FDA, EMA) is an asset
Ability to work unsupervised taking responsibilities for own actions
Ability to work in a quickly changing environment

Clinical Trial Assistant Resume Examples & Samples

Support Clinical Operations Lead (COL) by planning of meetings including logistics and minute taking, follow-up of deliverables of team members
Cooperate with Clinical Project Managers (CPMs) and/or Associate Clinical Project Managers (ACPMs) on all aspects of clinical trials and provide support with administrative duties
Participate in Clinical Study Team meetings and/or other trial-related meetings as appropriate. If not outsourced to CRO/Partner, prepare, distribute and file agenda, minutes and meeting materials as required
Set-up, maintain and manage TMF in collaboration with the ACPM/CPM and TMF personnel; responsible for assisting with ongoing and final QC checks of TMF; providing CRO or Partner with queries/feedback to assure correctness and completeness of documents and of TMF overall. Provide oversight of the TMF maintenance and management duties performed by the Partner
Draft and/or assist with the preparation of trial-related documents, tools and templates if not outsourced to CRO, including newsletters as applicable. Provide study specific review and file documents in the Trial Master File (TMF) in cooperation with CPMs and/or ACPMs
For studies not using the standard SP metrics, create and maintain designated trial tracking systems in accordance with trial requirements to ensure accuracy and completeness of information gathered. Contribute to the update of trial status report(s) and overviews

Clinical Trial Assistant Resume Examples & Samples

Bachelor’s degree in life science or related field and 6-18 months clinical research experience, or equivalent combination of education, training and experience
Knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and local regulations
Ability to establish and maintain effective working relationships with coworkers, managers, Project teams and site staff

Clinical Trial Assistant Resume Examples & Samples

School diploma/certificate or educational equivalent; or equivalent combination of education, training and experience; BS/BA preferred
Must possess a general knowledge of applicable clinical research regulatory requirements; including GCP and ICH guidelines
Strong Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint

Clinical Trial Assistant Resume Examples & Samples

Assist with preparation, planning, execution and close-out of clinical trials
Serve as document control coordinator and assist with maintenance of the Trial Master File
Assist with site feasibility collection and data entry
Assist with project and site level set up in the Clinical Trial Management System
Create Investigator Site Binders
Assist with IRB submissions and annual review as needed
Assist CRA with collection/review of essential documents as needed
Maintain spreadsheets to support study progress including files and logs to track samples
Assist with ordering clinical supplies and facilitate preparation of specimen collection kits
Facilitate/track site shipments and assist with sample handling and management
Participate in team meetings and generates meeting minutes
Provide Monitor Listings to external vendors/sites as requested
Perform quality control functions on clinical trial documents
Assist CRA with monitoring visit activities as needed
Additional project and tasks as determined by department and organizational needs
Work under close to normal supervision
Basic knowledge of clinical trial practices
2 years of experience in a relevant medical/scientific field or equivalent

Clinical Trial Assistant Resume Examples & Samples

Organize and maintain project working files and track critical documents. Report discrepancies to the appropriate clinical team member in a timely manner
Support the Clinical Trial Management/operational study teams in the execution and delivery of studies
Reconcile and transmit all essential documentation to the Trial Master File
Collect and track patient enrollment information and update study management reports as necessary
Bachelor degree or higher preferred
One to Three years of relevant experience in pharmaceutical industry or CRO
Experience supporting clinical trials preferred

Temp-clinical Trial Assistant Resume Examples & Samples

Essential Functions required for the job. List both technical and managerial requirements if applicable
Supports CSTL or other study team members with study start up, execution and close-out activities
Assists in the writing, collection, distribution and filing of meeting agenda and meeting minutes
Supports the scheduling and coordination of project team meetings
Assists CSTL or other study team members with requesting, collecting, and reviewing site regulatory documents
Tracks site study start up status and activities
Initiates, maintains and reconciles study TMF with CSTL guidance
Organizes and maintains data in CTMS
Maintains site monitoring visit schedules
Submits required material to internal review committees (RCRC) and may attend review meetings on behalf of the study team
Participates in tracking and reporting study data for management reports
Ensures lab reports are delivered to the medical monitors for timely review
Assists with vendor management
Uses judgment to escalate issues to the appropriate team members for consideration and resolution

Clinical Trial Assistant, Role Will be Based Resume Examples & Samples

May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval
Knowledge of applicable protocol requirements as provided in company training
Effective time management and organizational skills

Clinical Trial Assistant Resume Examples & Samples

Set up and maintain clinical investigator files and documentation
Prepare investigator budget payments and tracking systems; generate tracking reports as assigned
Data entry and maintenance of selected study tracking databases
Prepare monitoring visit documentation for Clinical Research Associates and above, as requested by supervisor
Prepare study-related documents and other materials for delivery to archives, at appropriate intervals
Provide clerical support to project team (e.g., assemble study documents, arrange meetings, shipment of study files, proofreading and editing correspondence, etc.)
Italian/German/English
French/German/English

Clinical Trial Assistant Resume Examples & Samples

Responsible for drivingthe FMCNA culturethrough values and customer servicestandards
Accountable for outstanding customer service to all externaland internal customers
Develops and maintains effective relationships througheffective and timelycommunication
Takes initiative and action to respond, resolvesand follows up regarding customer service issues with all customers in a timelymanner
General Administrative dutiesincluding: phone, fax, scanning, mailing, preparation of presentations
Obtains and updates licensure and regulatory documents for specificstudies, study sites, field personnel, as necessary. Assists with obtaining and processing documents and field level approvals for Investigator Initiated trials as necessary
Communicates with Institutional Review Boards, study sponsors, other CROs, dialysisfacility and FKC field staff as appropriate
Monitors study activity by tracking enrollment across sites
Keeps entries in Clinical Trial Management System (CTMS) up to date for all ongoing studies
Tracks payments associated with clinical trial agreements, if applicable
Generates expense reports as requested
Provides general supportfor research projectsas directed by Department Directors
Supports annualcompliance audit, if applicable
Contacts are typically with individuals within own department and with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation
Assists with various projects as assigned by direct supervisor

Clinical Trial Assistant Resume Examples & Samples

Updates and maintains tracking logs and CTMS system
Tracking if ICH/GCP and/or FDA 21 CFR essential study documents using the applicable tracking tools
Records and compiles minutes from team meetings
Stores and ships ancillary supplies to sites
Assist project managers and CRA’s with developing/printing TMF binders
Assist project managers, LCRA’s and CRA’s with mailings to sites, faxes, regulatory documents
Assists as directed in file audits
Completes IRB submission; Review submission package for completion and accuracy before submission to the IRB, ensures that the submission is done and that any issues resulting from these submissions are followed-up in a timely way
Submitting Safety Updates (SUSAR’s and SAE’s) to the investigators and the Central IRB
Collaborates with internal project team members to assure timely site initiation process
Reviews Clinical Trial Management System (CTMS) information to ensure documents are current and update as needed. Inform CRA regarding expiring documents
Scan and upload documents to the eTMF system if applicable, ensure documents are of good quality prior to upload
Assist in the planning and execution of Investigator Meetings
Reviews regulatory documents for completeness and accuracy
Preparing the archiving of the study documents and/or return of the documents to the sponsor of the trial, per the agreement with the sponsor and the applicable SOP
Writing letters, faxes, emails and telephone reports
BS (or equivalent) in science related field is preferred but not required
Working knowledge in Microsoft Office Suite (Word, Excel, Outlook, Power Point)
Ability to work independently and initiative are required
Strong organizational skills to cope with multi-tasking which result in a goal-oriented approach without losing the attention to detail

Clinical Trial Assistant Resume Examples & Samples

CTA experience from within the pharmaceutical or medical device industry highly regarded
Experience with CTMS and Oracle Clinical highly regarded
Experience with electronic Contract Management Systems and payment systems such as eCATS
Familiarity with ICH-GCP, ISO 14155 and ANZ Regulations and Guidelines
Ideally you will have tertiary qualifications in medical/ science/ nursing/ administration or equivalent field along with relevant work experience

Clinical Trial Assistant Resume Examples & Samples

Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
Collaborate with CTL 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 for accuracy and completeness
Collaborate with CTL on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
Assist in training and orienting new staff. May act as a mentor for less experienced CTAs
Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
School diploma/certificate or equivalent combination of education, training and experience

Stage Clinical Trial Assistant Resume Examples & Samples

Core competencies of clinical trials conduction
Ability to work in teams and in a complex matrix organization
Organizational and management skills, problem-solving, risk analysis
External relationships capabilities
Scientific degree or Master in Clinical Research
Strong Office IT skills, confident/advanced user of Microsoft Office (Word, Excel, PowerPoint as proficient user)
Self-starter and fast learner, with the ability to work independently as well as collaboratively

Clinical Trial Assistant Resume Examples & Samples

Monitors clinical studies and sites for adherence to protocol, GCP and company SOPs
Ensures timely enrollment against plan
Ensures quality of data generated from clinical sites and assists in resolving patient eligibility and protocol deviation issues
Maintains multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample tracking
Assists in the structure development of the TMF and filing system and is responsible for filing and maintaining up to date study documents
Assists in the design, format and content of CRFs study guides and subject instructions
Prepares, packages, and sends documents and materials to clinical trial sites and vendors as needed
Tracks and coordinates CRO and third-party vendor activities
Receives and reviews all regulatory documents from sites for accuracy and compliance to company SOPs and federal guidelines, tracks all information for reference, and maintains documentation as required
Ensures that regulatory documents are updated in a timely and appropriate manner
Assists with the development of site tools and clinical trial start up activities
Secures, with guidance from study lead, clinical trial insurance to support study start up
Coordinates Contracts Approval Process, including obtaining appropriate approvals and signatures for all clinical Agreements in accordance with corporate policies to ensure compliance and standardization of process
Prepares, requests, and tracks Purchase Orders for contracted services across the clinical study (ies)
Reviews subject visit schedules, site budgets, and clinical database to approve site payments
Confirms the accuracy of administrative data
Provides general support to the Clinical Operations team
Performs other related duties and tasks, as required
Assists with the organization, management and conduct of internal
1-2 years’ experience within the Pharmaceutical/CRO industry or equivalent site experience
6-12 month contract

Clinical Trial Assistant Resume Examples & Samples

Maintaining Trial Master File (TMF) and Clinical Trial Management System (CTMS) in an inspection-ready state, assisting with site management, initiating collection, reviewing and tracking of essential documents throughout the life of the trial
Contribute to the production and distribution of study materials and site/study communications
Assisting with tracking, logging and emailing / shipping site materials (syringes), following up on shipments and helping to both send, track and maintain feasibility questionnaires,
Working to support daily study activities providing project tracking support, review clinical study documents for completion, accuracy, expiration and submitting into the TMF
Assist with site management, initiating collection, reviewing and tracking of essential documents
BA Degree – required; preferred area life sciences
Computer skills – electronic skills important
Prefer an associate with 3 years of ICH – GCP experience
Oncology preferred if available
16 - 20 hours per week to start – Preference is office based will consider home based professional with demonstrated skills

Clinical Trial Assistant Resume Examples & Samples

Minimum Bachelor’s Degree from a 4-year college or university
Knowledge of clinical development phases and processes
Superior written and spoken communication skills in English
Knowledge of or experience in the Life Sciences industry (pharmaceutical, biotechnology or CRO experience preferred)
Has knowledge of technology within the industry
Work well with people from a variety of different backgrounds and cultures
Build relationships with clients and co-workers
Can work independently and as part of a team
Take active measures to solve problems and commit to a high level of service