As a Clinical Trial Associate (CTA) am solely responsible for the collection, review, tracking, maintenance and archiving of essential study documents in the Trial Master File (TMF), ensuring that project specific administrative documents are maintained, and sites are supplied with all required clinical materials and supplies. Duties and Responsibilities
• Provide administrative support to the Clinical/Regulatory project team
• Assists the Project Manager (PM) with written and verbal communications to the study team and sites
• Reviews Clinical/Regulatory documents submitted to the Site Master File (SMF) by the study team for accuracy, completeness, and compliance with internal and Client quality standards to fulfill all federal and local regulations
• Ensure paper SMF documents are named according to standard naming conventions
• Assist the project team with reconciliation of the periodic SMF QC
• Assist in the close-out of projects by performing a final QC of the SMF, identifying items and issues for review and/or follow-up by the CRAs.
As a Clinical Trial Associate (CTA) am solely responsible for the collection, review, tracking, maintenance and archiving of essential study documents in the Trial Master File (TMF), ensuring that project specific administrative
documents are maintained, and sites are supplied with all required clinical materials and supplies.
Duties and Responsibilities
- Clinical Trial Associate at Advanced Clinical Contractor at Rexahn Pharmaceutical
- Clinical Trial Assistant at Tasly Pharmaceutical
- Clinical Trial Associate / In-House CRA at Protalex, Inc
- Clinical Trial Associate / Project Manager Assistant at AnGes, Inc
1 year, 6 months at this Job
- Bachelor of Science - Business Administration / Marketing
- Associate of Arts - AA, Administrative Assistant and Secretarial Science
• Assist the Clinical Trial Manager with accurate updating and maintenance of clinical systems that track site compliance and performance within project timelines
• Assist the study team by preparing, handling, distributing, filing and archiving clinical documentation and reports according to standard operating procedures. Performs periodic review of study files for accuracy and completeness
• Assist in the development of recruitment strategies and materials for clinical trials
• Assist with Investigator meeting planning and the coordination of vendors and other participants
• Prepare, handle and distribute clinical trial supplies and maintain 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 study team for designated project communications, correspondence and associated documentation
• Develop and implement systems that support the achievement of clincial trial oversight and data quality
• Perform assigned monitoring and administrative tasks to support team members with clinical trial execution IQVIA/DrugDev Start-Up Specialist II (contract/Joule Clinical)
• Lead Specialist closing out a 500 site global study
• Set up and maintain project related systems, dashboards and document templates
• Coordinate communications, distribute surveys, documents and clinical information to sites and client sponsors; follow-up in accordance with study requirements
• Perform quality review of project/regulatory documents with investigator sites
• Collect, upload, maintain and reconcile investigator site documents to eTMF
• Primary point of contact for investigator sites
• Create, run and distribute project reports
• Assist in preparation for regulatory and/or sponsor audits PRA (formerly RPS, Inc.), Blue Bell, PA Sr. Clinical Trial Associate/In-House CRA II
• Ensure required project specific role based curriculum training is completed per specified timelines and updated in the Learning Management System as required
• Mentor and on-boarding train new hire Clinical Trial Assistants
• Interviewing potential Clinical Trial Assistant candidates
• Generate and maintain databases, including CTMS and IWRS for appropriate study administration
• Prepare and perform a periodic review of the Trial Master File (TMF) including all GCP-related documents
• Prepare study site files, reviews for accuracy and completeness and sends to sites prior to study initiation visits, as required
• Administer all study and related documents before and during the course of the study (i.e. drug accounting documents, correspondence, monitoring reports, contact reports, and other organizational papers)
• Manage start-up Start-Up activities, including site feasibility, regulatory document collection & review, ICF review and IRB approval, SharePoint creation & maintenance, Clinical Trial Management Plans creation & finalization, distribution & filing
• Prepare and submit project status reports for the Sponsor
• Manage documentation, finalizing and distributing all project team/Sponsor meeting minutes and agendas
• Track Feasibility Status (i.e. Investigator Site Selection activities) and Site Agreements
• Order and track Clinical, Non-Clinical Supplies and shipment of Investigational Product (IP) for all sites
• Maintain/QC electronic tracking within TrakWare(TM) of regulatory documents, IND Safety Letters, CDAs and other clinical trial documents per contractual obligation, as required
• Maintain and track IND safety letter communication and shipment to sites (e.g. communication to sites in timely manner, acknowledgement of receipts, send for translation where applicable, send translated documents to sites for IRB submission, etc)
• Communicate with translation vendor(s) to send and receive documents for translations and obtain costing from translation vendor(s)
• Track study enrollment, IP, and study equipment logs, provide updates to the study team
• Preparation/attend Investigator/Kick Off meetings and CRA training meetings
• Update all study related logs (i.e. Enrollment Logs, Frequently Asked Questions, etc.) and distribute them to the Regional CRAs
• Responsible for filing/auditing/reconciling clinical trial documents including but not limited to agendas, meeting minutes, telephone contact reports and monitoring visit reports to be filed within the Trial Master File (TMF)
• Routinely forward batched copies of all final trip reports (i.e. electronically via email and/or hard copy) to the Sponsor as indicated per the Project Team's Monitoring Plan
• Routinely run status reports regarding investigator grant payments and other miscellaneous payments as needed (i.e. IRB fees, lab fees, etc.) within the contractual timelines
• Generate/Track check requests for Investigator, vendor payments and pass-thru payments
• Track reports for all incoming Invoices for pass-thru costs
• Initiate and maintain site and CRA communications and distribute study related information
• Ensure timely and accurate study related communication is distributed to the clinical study team
• Join CRAs at sites for support activities such as documentation review, SIV, and drug accountability
• Regulatory Affairs Activities: Reconcile and maintain study eTMF and sponsor SharePoint; manage vendor-maintained eTMF at study closeout and final study file transfer to sponsor company; Ensure critical regulatory documentation is reconciled/provided to the FDA
• Maintain study team access to various systems such as IWRS, RAVE, V-TMF, SharePoint and IntraLinks
• Run reports regularly to check for inconsistencies and resolve issues globally during all study stages, Start Up through Closeout
- Clinical Trial Associate at Endo Pharmaceuticals/KPS Life, LLC
- Project Manager at Almac Clinical Technologies
- Clinical Trial Support Specialist at Pfizer, Inc
- Project Associate II at PRA International
6 years, 5 months at this Job
- Bachelor of Business Administration - Business Administration
• Provides administrative support to clinical projects under direction of line manager, Clinical Research Specialist and/or other designated clinical team members. Assists with general administrative functions as required.
• Performs regular review of Trial Master Files for completeness.
• Assists 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.
• Assists 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.
• Assists CRS/iCRS, CRAs/CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assists with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Acts 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.
- Clinical Trial Associate at IQVIA
- Project Assistant at PPD
- Patient Care Coordinator at Hometown Urgent Care
- Registration Representative at Ohio State University Emergency Department
2 months at this Job
- Masters in Health Law & Policy - Health Law & Policy
- Bachelors in Exercise Science - Exercise Science
Receive, review, track/inventory and appropriately file within Trial Master File or deliver to sponsor all documents from internal team, sponsor and sites. * Reviews documents received from sites for accuracy and completeness. * Reviews Informed Consent modified by investigator site. * Coordinates central IRB submissions. * Review and approval of essential documents for IP release * Receive, review and track regulatory documents required for the study site activation and maintenance (FDA 1572, Investigator CVs, Financial Disclosures, IRB approvals, Informed Consent, credential checks, lab reference ranges, protocol signatures, Investigator Brochure, etc.) * Prepare, maintain, and return/archive Trial Master File as applicable. * Perform Quality Control Trial Master File reviews as outlined in project specific plan and applicable. * Request, manage, distribute and track study supplies. * Compile weekly/monthly data and financial reports. * Mentor, train and teach new hires on departmental tasks and provide guidance as needed. * Update and maintain study-specific trackers and systems under direction of Project Lead. * Coordinate, set up, and attend project meetings including: internal, CRA, client meetings and presentations. * Provide administrative support for project teams including: mail merges, mass mailings, mass email distributions, and newsletters per contract specifications. * Assist with distribution and processing of protocol amendments, IND Safety reports and investigator brochure updates to sites. * Assist in identifying and implementing best practices and continuous improvement plans within the department/company. * Maintain working knowledge of Theorem Clinical Research standards/SOPs and FDA/ICH guidelines and regulations.
- Clinical Trial Associate - II at Theorem Clinical Research
- Women's Shoe Sales Associate at Macys, Inc
- Clinical Trial Associate at Theorem Clinical Research
- Project Master File Coordinator at Omnicare Clinical Research
4 years, 11 months at this Job
- Bachelor - General Studies
- A. S. - Summa
Build clinical trial kits for clinical trials hospitals Execute quality control of kits built by other associates in order to insure proper delivery of the orders
Build clinical trial kits for clinical trials hospitals
Execute quality control of kits built by other associates in order to insure proper delivery of the orders
- Clinical Trial Associate at Q2 Solutions
- Visual Merchandiser at THE HOME DEPOT
- Ekg Technician / Unit Secretary at MOUNT SINAI HOSPITAL OPEN HEART SURGERY FLOOR
- Teller/Teller coordinator/Personal Banker/Assistant Manager/Manager at BANK OF AMERICA
9 months at this Job
- ASSOCIATE OF ARTS - MANAGEMENT
• Lead Project Manager in closing out research studies and study sites and ensuring necessary documentation and payments have been completed
• Assist in informed consent development and version tracking
• (CTMS), monitoring visits, enrollment, laboratory samples and clinical trial agents (drugs/biologics), data cleaning, other vendor tracking tools and training.
• Assist in the development of clinical trial documents including protocols, manuals, SOPs, trackers, policies.
• Assist in preparation and documentation of internal and external meetings by preparing agendas and minutes
• Provides administrative support to research disease programs
• Provides administrative support to associate director of clinical operations includes but is not limited to scheduling meetings and calls, preparing agendas, distributing materials for disease program meeting.
- Sr. Clinical Trial Associate, USOR at Mckesson
- Internship/Volunteer, Patient Coordinator at Hospice Plus
- Lead Research Coordinator at Research Specialists of Texas
- Lead CCRP at Clinical Trial Network
1 year, 8 months at this Job
- Bachelor of Science in Health - Health/HDFS
- Associates of Science
- Diploma in Vocational Nursing - Vocational Nursing
- - Business
- Diploma in Medical Assistant - Medical
• Managed the Global eTMF Reconciliation Team that performed critical review of the eTMF for Site and Study essential document reconciliation, identified discrepancies, oversights, and necessary action items, as well as coordinated with pertinent team members, to ensure a complete and accurate eTMF
• Set up and maintained project-specific tracking systems for a Global Study - e.g. Site Feasibility Information, Protocol and Investigator Brochure distribution, contract management, Case Report Forms tracking, Subject Logs, Drug Accountability, CRA Visit Calendar and Documentation Tracker, as well as Patient Level tracking in the eCRF
• Prepared project-specific support materials and templates in accordance with the study protocol
• Managed the content of the project Trial Master Files and ensured its accuracy and completeness, including paper files and the electronic Trial Master File (eTMF)
• Assisted in the preparation and management of regulatory and ethics applications for clinical research studies
• Managed study materials and supplies distribution and receipt at appropriate stages of the study
• Worked closely with Project Managers to implement effective start-up and close-out of clinical trials as well as provided regular progress updates on all tasks
• Collaborated with employees at various levels in the organization on the eTMF Best Practices Task Force
• Scheduled and participated in Project Team meetings as required and, where appropriate, prepared meeting minutes
- Clinical Trial Associate at EMAS PHARMA CRO (Contractor)
- Centralized Scheduling Coordinator/Insurance Verification Specialist at OVERLAKE MEDICAL CENTER
- Cocktail Waitress/Bartender/Server at Red Robin
- Patient Service Representative at OVERLAKE MEDICAL CENTER Department of Pulmonology
7 months at this Job
- Bachelor of Arts - Family and Child Studies
• Gathered and the preparation of documents for clinical trial applications for the submission and approval from the competent authority and ethical committees
• Assisted in updates of all clinical trials tracking tools for Trial Master File (TMF), monitoring visits, enrollment, and vendor tracking and training. Maintenance of program/study related files and electronic filing systems as requested.
• Maintenance of study team contact list, vendor contact lost, site contact list.
• Assisted with the review, tracking and processing of payments/ invoice related to investigators, consultants and service providers (including initiation and follow up queries)
• Assisted in preparation and documentation of internal and external meetings by preparing agendas and minutes.
• Assisted the Project Manager in communicating with the sites for various purposes, including site updates, and query resolution.
• Assisted in the production of slides, overhead, etc., as needed for project, departmental, and sponsor.
• Created Site Study Binder, assembly, and shipment.
• Receipt of Helpdesk calls from investigator sites, record the issues and resolution of the issue.
- Clinical Trial Associate at CurAccel, LLC
- Clinical Trial Assistant at CurAccel, LLC
- Credit & Returns Assistant at Phillips Pet and Food Supply
- Warehouse Associate at VF Majestic
1 year, 2 months at this Job
- Associate - Health Science
- High School Diploma - Hotel and Restaurant Management
Assist with study start-up activities including development of the first draft of the ICF. Maintain knowledge and act as team super user for related eTMF and EDC systems (e.g. TransPerfect eTMF, PhlexGlobal, Veeva Vault). Work with CRAs in proactively maintaining / up-dating essential documents as required Manage study specific PO Creation. Responsible to ensure Clintrials.gov is updated accordingly. Participate in creation and distribution of specific study aides/materials and communications. Provides input and coordinates the delivery of clinical trial supplies in collaboration with the clinical supply team. Collect & collate documents required for EC/IRB/HA submissions. Review background information of potential new sites Support SUSAR distribution. Assists study team with preparation for audits/inspections Coordinate the delivery of clinical trial supplies in collaboration with the clinical supply team. Responsible for the development of any mass site communication as appropriate. Manage tasks associated with study management such as site visits, CRA management, clinical document/ report review, ICF template generation and/or review, review IMP release packet prior to initiation, etc. Track and report on progress of the study including site activation, patient enrollment and monitoring visits. Assists the CTM in identification of potential risks to the enrollment targets based on feasibility analysis Working with external vendors under supervision Contact sites for data entry/data quality concerns and alert CRA of any issues prior to the next scheduled monitoring visit.
- Senior Clinical Trial Associate at Karyopharm Therapeutics
- Clinical Trial Associate at TESARO
- Clinical Trial Associate at McKesson Specialty Health/ US Oncology Research
- Clinical Research Coordinator at Dana-Farber Cancer Institute
1 year, 11 months at this Job
- Masters - Healthcare Administration and Management
- B.A. - Psychology & History
Utilize organizational and detail-oriented skills within a clinical research organization to ensure high-quality and timely goal completion. Contribute collaboratively to oncology and HIV clinical trial teams with a range of analytical, interpersonal, and technical skills within the fields of clinical trial management. Independently manage site load and organize project tasks. * Experience with Informed Consent Forms, Regulatory Compliance Review, translation requests, and Sponsor Transmittals. * Analyze clinical data, run study metrics reports, and create templates to streamline team efficiency. * Take meeting minutes and multi-task study responsibilities while allocated on numerous clinical trials. * Work extensively with eTMF, CTMS, and Microsoft Office systems for efficient document management and processing.
- Clinical Trial Associate at Pharmaceutical Product Development
- Full-Time Multiple-Subject Educator at Los Angeles Unified School District
- Native English Educator at Seoul Metropolitan Office of Education - English Program In Korea
10 months at this Job
- - Teaching
- Bachelor of Science in Environmental Sciences - Environmental Sciences