2 (Site Monitoring)
• Assist Clinical Research Specialist (CRS)/In-house Clinical Research Specialist (iCRS), Clinical Research Associates
• Updating and maintaining clinical systems for site tracking of compliance and performance.
• Assisting with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Collaborating with study team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Conducting periodic review of study files and completeness
• Acting 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. Trial Master File (TMF) Specialist (Site Monitoring)
• Acted as a Subject Matter Expert (SME) supporting the management and oversight of TMF (Trial Master File) activities for paper, electronic and customer TMF systems to ensure delivery of a high quality TMF.
• Conducted review of documents with compliance to Quintiles or customer file plans and SOPs.
• Served as a TMF contact for documentation to the project team, and cross functional departments to ensure high quality TMF deliverables are met on time.
• Monitored, identified and recorded quality problems, suggest, initiate, recommend or provide solutions as appropriate.
• Managed documentation associated with assigned clinical trials.
• Facilitated collecting, processing and disposition of various project-related records for paper & electronic documents to sponsor.
• Provided support & involvement with internal quality or audit process's as relevant.
• Reports TMF health findings at required frequency
• Alerted Project team and TMF Quality PM to any potential TMF Health issues
• Collaborated on TMF Quality for assigned sponsor trials Clinical Trial Assistant (Global Functional Resourcing- Lilly)
• Collaborated with Project Team Lead (PTL) on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Supported milestones achievement through all phases of study: SSU, Maintenance, and COVs.
• Acted as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• Performed assigned administrative tasks to support team members with clinical trial execution.
• Assisted with information management for site, project, and team activities in established systems and spreadsheets.
• Acted as Monitoring log report reviewer.
• Assisted with preparation of study files for audits.
• Supported Project Team Leads with entry of current site status into management system prior to site visits and meetings
• Assisted with development and implementation of project-specific forms and work instructions.
• Provide Project Team Lead (PTL) and Clinical Research Associates (CRA) with weekly and/or monthly data management reports with consist of Open/Answered Queries, Missing Items, Blank Forms and Missing PI Signatures.
• Assisted (PTL) during database lock (DBL) to ensure all data management issues are resolved by communicating with the CRAs and LMs.
• Assisted with meeting preparations, generation, and distribution of minutes, and filed specific information for designated project meetings.
• Provided project study team leads with multiple reports on a weekly and/or monthly metrics and reports which consist of: Global Deviation Reports, Monitoring Interval Report, Issue Escalation Report, eTraining Compliance Report.
• Created, maintained and initiated study team e-Trainings as directed
• Initiated PI status reviews and filed correspondence.
• Assisted with Start-up process; adding files in eTMF, site & PI information into CTMS
• Supported Quality team with audits by providing monitoring documentation for their review
• Ensured accuracy of entries of completeness and maintenance of internal systems, databases and tracking tools with project specific information.
• Provided updates to the PTLs, LMs and CRAs on project specific activities: statuses, accesses and other updates as requested. Additional Tasks
• Assisted in training CTAs and mentoring new CTAs.
• Lead role Site Initiation Visit Rejuvenation Report
• Lead role for the eDC access for all Quintiles/Sponsor employees
• Updated guidance documents
• Supported eTMF Folder generation
• Trained PTLs, LMs and CRAs on monitor log completeness and correctness.
• Attended On the Job Shadowing Site Manager Roles and CRA co-monitoring visits
- Clinical Trial Assistant at IQVIA
3 years, 11 months at this Job
- Bachelors - Public and Non Profit Adminstration
- AAS - Clinical Trial Research I
Started as volunteer in the Hospital, in oncology department for few months, dealing with patients, doctors order/ drug administration, Noticing patient blood counts daily and administrating blood according to their level.
• Performed start up project duties including selection and assignment of employees to specific tasks, delegation of responsibilities, review of timelines, risk management and ensuring timely completion of assigned studies.
• Used Clinical Trial Management System (CTMS)
• Maintained quality by ensuring SOPs, GCPs, and compliance with company guidelines
• Established strategies to ensure deliverables that delivered quality, timeliness and resources
• Facilitated team communication and attended applicable meetings
• Applied strong analytical thinking to resolve arising issues and guarantee excellence of project studies
• Conducted contingency planning, scenario analysis and propose strategies
• Understood detailed clinical development/trial execution
• Awarded additional bonus in recognition of extra ordinary work upon successful completion of comprehensive clinical trial
- Clinical Trial Assistant at Everest Clinical Research Corporation
- House Officer (Medical Doctor) at Institute of Medical Sciences
- Hands on research assistant Research Internee at Environmental Analytical Laboratory
11 months at this Job
- Bachelor of Medicine and Bachelor of Science - Biochemistry and Pharmacology
-Maintain knowledge of GCP/ICH guidelines -Mentor incoming CTA’s -Set up, organize, and maintain clinical study documentation including preparation for internal/external audits, final reconciliation and archival. -Assist in quality control audits of clinical study documentation - Run metric reports needed for PM/CTM - Submit Flat file to IT to get uploaded into ICOTrial - Receive invoices and review with contract -Facilitate ordering and distributing supplies/materials to sites -Assist project team in preparation for Site Monitoring Visits. -Assist project team in preparation for Close Out Visits. -Maintain and manage data entry into clinical tracking systems to ensure that the project information is current, accurate and complete.
- Sr. CLINICAL TRIAL ASSISTANT at ICON Clinical Research
- CLINICAL TRIAL ASSISTANT at ICON Clinical Research
- FINANCIAL CARE COUNSELOR at DUKE UNIVERSITY HEALTH SYSTEMS
- SURGICAL TECHNOLOGIST at DUKE UNIVERSITY HOSPITAL SYSTEMS
1 year at this Job
- Certificate - Clinical Trial Research Associate
- ASSOCIATES - SURGICAL TECHNOLOGY
Responsibilities: To process a knowledge of ICH GCP, appropriate regulations, relevant ICON SOPs, ICON internal tracking systems, and Client SOPs/ Client Systems. To assist the project teams with the set-up, organization and maintenance of clinical study documentation and guidelines including preparation for internal/external audits, final reconciliation and archival To assist in the processing of Data Collection Forms To share responsibility in the quality control audits of clinical study documentation to ensure study files are inspection ready at all times To facilitate and coordinate ordering/dispatch and tracking of trial materials To assist project teams with trial progress tracking by updating the Clinical Trial Management systems To run, review and anazlye study reports To contact and serve as a contact for clinical sites for basic requests To assist in the tracking and distribution of safety reports To assist and attend the Project team with meeting coordination, activities preparation, generation of meeting minutes To work in collaboration with internal and external colleagues to meet project objectives and timelines
- Clinical Trial Assistant at ICON plc
- Workers Compensation/Scheduling Coordinator at Elite Sports Medicine
- Office Assistant at Jessup Eye Care
- Front Desk Receptionist at Massage Envy
8 months at this Job
- Master's - Health Care Administration
- Bachelor of Science - Psychology
• Assisted with Trial Master Files (TMF) and archived clinical trial documents in accordance to related SOPs.
• Created and sent clinical trial materials to study sites such as regulatory binders, labels and maintaining gift cards.
• Received, inspected and conducted inventory of clinical trial supplies to ensure appropriate quality, quantities and storage conditions of materials or supplies as well as completing relevant documentation and communicating to Clinical Teams.
• Performed picking, packing and shipping clinical trial supplies and/or clinical samples insuring accuracy of items and quantities with appropriate packing materials and shipping conditions (e.g., frozen, refrigerated and ambient), as well as shipping instructions to insure compliance with shipment guidelines and local and federal regulations.
• Completed additional duties as requested by trial manager or designee.
- Clinical Trial Assistant at Roche Molecular System, Inc
- Clinical Contracts and Finance Associate at Gilead Sciences, Inc
- Clinical Project Assistant at Grail, Inc
- Clinical Trial Coordinator (CTC) Supervisor at Penumbra, Inc
2 months at this Job
- Bachelor of Science - Biology
• Supports a phase four study focusing in CLL
• Communicates directly with sites, Contract Research Organizations (CROs) and field CRAs to obtain updated information, essential documents, etc. to assist with study conduct
• Successfully maintain, review and track trial management file (TMF) documents such as clinical trial agreements, financial disclosure forms, medical licenses, and CVs, along with update CT.gov posting relating to the trial
• Handles incoming and outgoing clinical trial related materials shipments to site, study team, CRAs and vendors, as needed
• Participates in clinical teams, including attending required meetings, and teleconferences/WebEx.
• Track, review and process CDAs, feasibility questionnaires and clinical trial agreements in the site selection process
- Sr. Clinical Trial Assistant at Pharmacyclics, LLC
- Clinical Research Coordinator at Seattle Children's Hospital
- Clinical Trial Assistant at Seattle Genetics, Inc.
- Research/Production Technician at Diagnos-Techs
3 months at this Job
- other - Clinical Trials
- B.Sc. - Molecular
• Provides administrative and project tracking support to Project Managers and Clinical Trial Managers
• Collect and process forms from study team, in addition to, initiating, maintaining, and reconciling Trial Master files
• Maintain knowledge of ICH GCP and regulations, ICON SOPs and internal tracking systems, and client systems and SOPs
- Clinical Trial Assistant at ICON plc
- NURSING ASSISTANT at Penn Medicine Vascular and Plastic Surgery
- NURSING ASSISTANT at St. Mary's Medical Center Cardiovascular Critical Care Unit
- PATIENT CARE TECHNICIAN at DaVita
10 months at this Job
- Post Baccalaureate Certificate, Pre - Med - Philadelphia P.A
- Bachelor of Science - Psychology
- Bachelor of Arts - English
• Provide central study support to project team members, management and sponsors
• Work with PM, PL, CL, CRAs, Regulatory and Start-Up (RSU) team members
• Maintain and manage Trial Master File (eTMF), CTMS and Investigator databases
• Support protocol amendment, ICF review and IRB approval activities
• Assists to perform file review, QC and approval of essential document package
• Responsible for regulatory IRB/IEC tracking and submissions
• Responsible for site monitoring and tracking for multiple clinical studies (start-up, maintenance & close-out)
• Central contact for the clinical team for designated project communications
• Collaborate with clinical team on the preparation, handling, distribution, filing of clinical documentation
• Assist in training and mentoring new team members
- Clinical Trial Assistant at IQVIA
- Senior Scientist at Oncimmune (USA), LLC
- Lead Scientist at Catalent Pharma Solutions
- Scientist at Quest Diagnostics, Toxicology
7 months at this Job
- Ph.D. - Biological Sciences
- Master of Philosophy - (M.Phil.), Neuroendocrinology
- Master of Science - (MS), Biological Sciences
•Utilize the Clinical Trial Management System (CTMS) and create trackers to ensure regulatory documents are accurately tracked and meet specified trial needs
• Serve as a key contact with regional and global sites on trial details, submissions & approvals, respond to issues and recommend corrective actions, as well as discuss recruitment issues
• Collect and review regulatory documents from clinical sites
• Initiate, maintain, and reconcile electronic and paper Trial Master Files
• Review IRB/IEC submission documents for discrepancies and monitoring visit reports for protocol deviations
• Assist in site selection and review feasibility for participation in Clinical Trials
• Review subject data and assist in following up on action items defined during monitoring visits until closure/resolution
- Clinical Trial Assistant at SGS - Life Sciences
- Intern at OpGen
- Department Manager at Harris Teeter
1 year, 5 months at this Job
- Bachelor's Degree in Biotechnology - Biotechnology
- Bachelor of Sciences in Biology - Sciences
With the GTM, prepare, distribute, manage, track and file clinical documentation and reports, from study start-up through final Trial Master File (TMF) archiving.
• Assist with accurately updating and maintaining relevant clinical study trackers, such as study start-up trackers, protocol deviation trackers, and clinical trial supplies trackers.
• Ensures all clinical study documentation is accurate, complete and in compliance with Good Clinical Practices (GCP), Good Documentation Practices (GDP), Code of Federal Regulations (CFR), SOPs, and sponsor protocol.
• Ensures that all clinical study documentation, such as DMP, Protocol, Investigator Brochure, informed consent, eDC completion guidelines, IDMC charter, CTA's etc., is appropriately filed in the TMF accordance with SOPs and the study-specific TMF Management Plan.
• Assists with the routine QC review of the study TMF, for accuracy and completeness.
• Participates in team meetings, including regional monitor meetings, sponsor meetings and internal team meetings as appropriate.
• Establishes and maintains a strong working relationship with the entire trial team, including sponsor representatives, Clinical Research Associates (CRAs), and investigational site staff as appropriate.
• Supporting investigative sites toward completion and appropriate submission of all required clinical trial documents, such as, confidentiality agreements, site feasibility questionnaires, site personnel CV's, medical license, ICH GCP training, and Clinical trial agreements prior to site initiation.
• Coordinating Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.
• Supporting overall progress of clinical trials by regularly attending clinical trial team meetings, reviewing team communications and sharing pertinent information with clinical trial team members and investigative sites, as requested.
• Assisting assigned clinical trial teams to ensure that each clinical trial maintains audit/inspection readiness at each site and internally throughout the duration of assigned clinical trials.
• Enter and maintain required documentation in study specific databases related to purchases, contracts, study document management, and other areas as required
• Responsible for the set-up of the Trial Master File, investigator study file binders and regulatory document collection.
• Co-monitor internal or external Clinical Study Site
• Data entry into eDC as needed.
• Responsible for maintaining and communicating project metrics via study trackers
• Assist in preparation of regulatory binders, study and/or pharmacy manuals
• Handling IP release activities on small, straightforward projects or support review for larger projects
• Set-up, populate and accurately maintain information in tracking and communication tools (e.g. IMPACT, SharePoint etc.) and support others in the usage of these systems
• Perform other duties as assigned by the GTM to support the clinical conduct of assigned studies.
• Responsible for startup of three trials, 20 sites total to PSIV, initiation of 6 sites in total.
- Clinical Trial Assistant at InClinica Inc
- Regulatory/ Site Contracts Coordinator at Clinical Research Center of Reading LLC
- Clinical Research Coordinator at Mid Atlantic Retina /Wills Eye Hospital
- IRB Coordinator at Saint Joseph Medical Center
1 year, 8 months at this Job
- Licensed Practical Nurse - Nursing