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.
• Collects, distributes and tracks receipt of regulatory documents and other trial related documents through the life cycle of the clinical trial as needed.
• Compiles key study information from various systems into a report format for tracking and trending metrics for study team.
• Creates and maintains logs of trial related documents. Distributes and tracks reports to clinical trial sites and CRAs.
• Distributes and tracks protocol deviations. Distributes, tracks, collates and summarizes feasibility information and provides to study team as needed.
• Generates potential site information from investigator database. Maintains trackers for essential trial related documents as needed.
• Provides administrative support to study team as needed for trial related tasks.
• Ensures that clinical trial documents are filed/uploaded accurately and within expected timelines. 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.
- 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
10 months at this Job
- Bachelor of Science - Business Administration / Marketing
- Associate of Arts - AA, Administrative Assistant and Secretarial Science
Support a team of 4 CRAs in a phase 2 Open - label study of Follicular Lymphoma and phase 1B Open - label Marginal Zone Lymphoma and phase 2 study in subjects with Myelofibrosis.
• Conduct co-monitoring visits.
• Conduct work activities in compliance with all relevant code of Federal regulations, ICH-GCP regulations and local regulatory guidelines.
• Prepare and load documents in Veeva vault. Documentation of all documents in appropriate folders.
• Maintain and update all clinical systems and monitor all study within timeframe,
• Review and evaluate all training documents, regulatory and essential documents submitted before loading in eTMF.
• Prepare all documents for site visits and maintain effective receipt of all regulatory documents from study site.
• Assist with monitoring visit report review to maintain oversight of clinical monitoring quality and adherence to protocol.
• Assist with filing and archiving project documentation in eTMF within the timeframe.
• Plan various study meetings and participate in associate meetings to provide support and documents all clinical study reports electronically.
• Attend CRO teleconferences / meetings when applicable.
• Coordinate with various study sites and evaluate same on periodic basis to ensure accuracy.
- Clinical Trial Associate - Oncology at Med Clinical Research LCC
- Clinical Trial Research Intern at Med Clinical Research LCC
- Quality Control Analyst at Stepan Lipids Nutrition
- Laboratory Technician at Safety-Kleen Systems, Inc
1 year, 10 months at this Job
- Bachelor of Science - (B.S.), Chemistry
• Support the Clinical Operations department in the planning, execution and management of in-house or outsourced clinical trials.
• Review, track and file study specific documents as well as create and update study specific reports.
• Exercise discretion and judgment in handling confidential information and follow FDA regulations, ICH guidelines and GCP in all tasks.
• Collect, file and/or track clinical trial associated regulatory documents.
• Coordinate and track the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF’s, monitoring visits reports etc.
• Maintain and ensure all documentation is in a state of audit readiness.
• Create and maintain of the Trial Master File and electronic Trial Master File (TMF and eTMF) according to ICH-GCP, and company SOPs.
• Assist in the preparation of study related documents, i.e. ICF, clinical trial tools, trackers & templates etc.
• Support drug supply planning and defining supply logistics.
• Coordinate and track or supervise drug supply.
• Coordinate and track clinical trial equipment and supplies.
• Review and track vendor invoices against contracts and coordinate approval.
• Assist with site budget process.
• Act as central point of communication for trial team as well as study sites and vendor personnel.
• Responsible for sending and tracking all safety letters to Investigators according to timelines provided by Manager, Clinical operations.
• Support the trial team to produce and distribute study newsletters as needed.
• Assist in the coordination of Investigator Meetings.
• Create agendas and record team meeting minutes and tracking of action items under the direction of the Manager, Clinical Operations.
• Assist the Manager, Clinical Operations with timeline maintenance.
• Perform administrative tasks to support Clinical Operations Department and team members as needed.
• Develop knowledge of sample collection and analysis process at the study level and may perform reconciliation and/or tracking of these activities.
• Under the guidance and direction of the Project Manager and/or Clinical Operations management, interfaces with other BeiGene functions to coordinate relevant and timely exchange of information / materials to support clinical trials delivery within the drug development process
• Assist with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations
- Senior Clinical Trial Associate at BeiGene
- Contract- Clinical Trial Lead/ Senior Clinical Research Associate at T2Biosystems
- Contract - Senior Regional Site Manager- home based at Allergan/ Planet Pharma
- Senior Clinical Research Associate II- home based at ICON
at this Job
- Bachelor of Science - Health Science/Interdisciplinary Studies
Lead the development and design of FIH Phase I/II trial in Huntington Disease patients, including the submission of an IND.
• Developed and Finalized Clinical Trial Documents, including a Clinical Trial Protocol, Investigator's Brochure, and ICF for a Phase I/II trial.
• Lead regular cross-functional Clinical Program Team meetings and Clinical Trial Team meetings to drive program development.
• Selected and managed a variety of vendors, including CRO's, Central Labs, Medical Writers, and others.
• Collected site feasibility data to drive site selection for a Phase I/II trial and participated in Site Qualification Visits.
• Supported site feasibility, site selection, and vendor development to initiate a PhIIb/PhIII trial.
• Participated in neurologist, neurosurgeon, and patient advisory boards to enrich program development.
• Aided in the development of EDC systems for multiple projects.
• Supported the management of the Trial Master File (TMF), i.e. set up and maintenance in line with ICH/GCP.
• Supported study finance processes.
• Collected and collated the data from the different departments needed in the management reports.
• Delivered routine reports, reviewing for accuracy and potential escalation items.
• Supported in the preparation of Ethics Committee submission packages within set timelines.
- Sr. Clinical Trial Associate at uniQure Inc
- Clinical Monitoring Associate at PAREXEL International Corporation
- Hematology Technician at Tufts Medical Center
- Research Assistant at Northeastern University Biology Department
1 year at this Job
- Masters of Science in Drug Discovery Skills and Pharma Management - Drug Discovery Skills and Pharma Management
- Bachelor of Science degree - Health Science
• Works to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines and government regulations.
• Participates in study start-up, conduct, and closeout activities.
• Collects and reviews site regulatory documents for accuracy and completion (1572, Financial Disclosure documents, CLIA waivers, etc).
• Assembles and distributes regulatory binders to clinical sites.
• Drafts and/or assists with the preparation of trial-related documents, tools and templates (start-up forms, ICFs, screening scripts, source documents, study logs).
• Supports project management activities including taking meeting minutes/providing agendas to the clinical team, tracking screening/enrollment across all sites, and maintaining study status trackers.
• Assembles and/or reviews regulatory packages for trial-related submissions to IRB/IECs, in accordance with ICH GCP, applicable regulations and Company SOPs.
• Maintains the Trial Master File for all clinical projects.
- Clinical Trial Associate at Ora Inc
- Clinical Research Associate at Accutest Research Laboratories (I) Pvt Ltd
3 months at this Job
- Master's - Clinical Research
- Bachelor's - Pharmacy
• Planning and coordination of clinical trials. Initiation, execution and close out of global clinical studies complying with international Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs).
• Responsible for supporting the Clinical Operations teams to achieve quality results in a cost-effective and timely manner.
• Coordinate the preparation, collection and execution of confidential disclosure agreements (CDA);
• Distribute, collect and review Financial Disclosures;
• Set-up, update and maintain clinical trial-related trackers such as regulatory documents, trial master file, startup progress, screening/enrollment, study invoices/payments, project budgets and others as necessary;
• Prepare, maintain, and archive trial master files (TMF);
• Perform trials master file reviews to ensure completeness and audit-readiness;
• Request, manage, distribute and track study supplies (Regulatory Binders, Study Reference Manuals & ancillary supplies);
• Provide detail reviews for protocol, informed consent form (ICF), case report form (CRF) design, etc.;
• Support audit/inspection readiness;
• Assist study sites with IRB/EC submissions and annual reports;
• Assist with compiling regulatory submissions;
• Coordinate, provide set up, and attend project meetings including: internal team, CRO / vendor meetings, support presentations, etc.;
• Regularly review documents to ensure adherence to Clinical Operations and/or project specific quality requirements (e.g. SOPs, work practices, training guides) as applicable;
• Assist with identifying and implementing best practices and continuous improvement plans within the company;
- Clinical Trial Associate at Bristol-Myers Squibb
- Clinical Research Coordinator at Health and Human Sciences, Purdue University
- Teaching Assistant, METU at General Biology, Physiology, Biochemistry Laboratory
- Graduate Assistant at Graduate School of Natural and Applied Science
2 months at this Job
- MS - Clinical Nutrition
- Master's - MS Nutrition Science
- - Research Assistant
- - MS Biochemistry
- - Research Assistant
- BS - Food Engineering
Responsibilities include: assisting the operational lead in the day-to-day management of complex or large full-service
studies or small multi-study programs; supporting design, overseeing implementation, and delivery and reporting of projects; accountable for time, cost and quality targets as well as resource and budgetary control throughout the duration
of projects; coordinate and direct cross-functional task leaders from all contracted services within ICON both locally and internationally and oversight of contracted third parties; anticipate and manage risks and issues within sites; ensure
compliance with ICON SOPs, study contract and international regulatory requirements
• Clinical Research therapeutic areas include: Oncology - Anaplastic Large Cell Lymphoma, Hodkin Lymphoma - Phase I; Hepatocellular Carcinoma - Phase II Endocrinology - Hypogonadatropin Hypogonadism - Phase II
- Clinical Trial Associate at Icon Clinical Research PLC
- Research Intern at Medstar Washington Hospital Burn and Surgical Laboratory
- Pre-Med Volunteer Program at Abington Jefferson Memorial Hospital
- at Skin Smart Dermatology
1 year, 3 months at this Job
- Bachelor of Science - Biology
• Executes clinical operations project management for multiple early phase projects within the Oncology portfolio (pre-clinical, translational medicine, clinical research, etc.).
• Collaborates directly with the US clinical site staff to ensure management and alignment on BMS business processes and execution of study timelines.
• Drives the collection and review of site regulatory documentation directly from US sites in accordance to SOPs, GCP and regulatory guidelines.
• Report program status updates (to include operational, data management, regulatory affairs, financial, achievement/risks/delays and mitigation plans) to management.
• Provide critical operational input for external site management, including clinical development strategy that is feasible in catchment areas.
• Provide leadership and oversight to new hires while overseeing my assigned day-to-day coordination, management & operational aspects of clinical sites to secure the successful completion of industry requirements, relevant guidelines (ICH, GCP, Ethics & company SOPs) within prescribed timelines, budget parameters for assigned program. In addition provided leadership to trial managers to ensure appropriate oversight of 19 protocols and external vendors (Clinical Research Organizations (CROs).
• Ultimately responsible for all clinical documents including protocol, investigators brochure, clinical study report, and informed consent form
• Works in collaboration with stakeholders to coordinate development and research tasks.
• Assist with process improvement and process document creation
• Study Start-up SME
- Clinical Trial Associate at Bristol-Myers Squibb via DOCS Global
- Regulatory Specialist at Moffitt Cancer Center
- Data Collector at University of South Florida College of Nursing
2 years at this Job
- Masters of Medical Science - Medical Science
- Bachelor of Science in Chemical Engineering - Chemical Engineering
• Perform general administrative tasks to support team members with clinical trial execution, e.g., assist with the development and formatting of documents, review and reconciliation of study-specific information, etc.
• Collect, disseminate, and/or track regulatory documents, as required.
• Assist with filing documents in the Trial Master File.
• Track and prepare study-specific information utilizing databases, spreadsheets, and other tools.
• Manage and track study-specific contracts and clinical study payments in applicable systems.
• Create and track purchase orders for clinical trial programs.
• Manage and track clinical and non-clinical supplies, including purchase and shipping.
• Assist with the development and distribution of site binders.
• Set-up and coordinate meetings, take and distribute meeting minutes.
• Authorize investigational product release.
• Assist in the preparation of Investigator and Study Coordinator Meetings.
• Communication for defined tasks and tracking of information between the study team and specified vendors.
• Set-up and maintain tracking systems (e.g., CTMS), tools and report study metrics to support the clinical trial programs.
• Participate in special projects, as assigned.
- Clinical Trial Associate at Ultragenyx Pharmaceutical, Inc
- Sr. Clinical Trial Associate at Precision Oncology, LLC
- Clinical Trial Associate at
- Team Leader at Soda Tax Policy, San Jose State University
7 months at this Job
- B.S. - Health Science
• Worked as clinical team member during study set-up, conduct, and close-out.
• Responsible for coordinating and managing contracted ambulant care services in support of sponsored pharmaceutical and biotech studies. Involved in phase II-IV studies in a variety of therapeutic areas, including oncology.
• Functioned as a liaison between Sponsor, CRO, Vendors (e.g. Central Lab), Country Coordinators, and Study Sites.
• Responded to Sponsor and Investigator queries.
• Reviewed ambulant care source documents provided by Country Coordinators and Service Providers.
• Resolved data inconsistencies with Country Coordinators and Service Providers.
• Updated and maintained electronic study data trackers.
• Attended Country Coordinator and Service Provider trainings.
• Participated in project teleconference calls and meetings.
• Inventoried study supplies.
• Provided 24/7 patient assistance for study sample collection and shipment to the Central Lab.
• Complied with ICH/GCP guidelines, patient data protection laws (HIPAA, GDPR), GlobalCare SOPs, and study requirements.
- CLINICAL TRIAL ASSOCIATE at GlobalCare Clinical Trials
- RESEARCH ASSOCIATE II at Baxter International Inc
- PhD CANDIDATE at Catholic University of Leuven
- INTERN at Pharmacy Villani
2 months at this Job
- PhD - Biomedical Sciences
- MSc - Pharmaceutical Chemistry and Technology