A Clinical Trial Associate is responsible for organizing and administering clinical trials of current or new drugs so as to assess the risks and benefits of using them. A well-drafted Clinical Trial Associate Resume indicates the following duties and tasks – writing drug trial methodologies, identifying and briefing trial investigators; setting up and disbanding trial study centers; providing clinicians with instructions on conducting trials; collecting and authenticating data collection forms; writing reports; and monitoring progress throughout the trial.
Key qualifications needed for the post include the following – a logistical and inquisitive mind; commercial awareness; good organizational abilities; excellent numerical and communication skills; and confidence. To become a Clinical Trial Associate, one needs to hold a degree or postgraduate qualification in life sciences or nursing. Higher professional qualifications provide opportunities for career growth.
Summary : Currently serving as a clinical trial associate for a contract research organization that provides 2D and 3D imaging services during clinical trials.
Skills : Microsoft Office, Mac OS X, IntraLinks, CTMS.
Description :
Reviewed clinical sections of informed consent documents and alert sites about revisions to be made.
Re-evaluated consents after IRB approval to ensure Novartis-required language is incorporated.
Tracked status of regulatory readiness and inform Clinical Study Manager of any issues or challenges in preparing sites for site initiation.
Submited regulatory documents to Central IRB for review and approval.
Maintained enrollment logs, site and vendor contact lists, and drug shipment tracker.
Ensured all reporting systems are kept up to date.
Responsible for project management for non-treatment studies such as registries and studies closed to enrollment as assigned.
Experience
10+ Years
Level
Senior
Education
Bachelor Of Science
Sr. Clinical Trial Associate Resume
Summary : Human resources strategist with diversified skills include strong client/customer relations, employee/labor relations, process improvement initiatives, employee retention and development, full cycle recruitment, HR project management and Clinical Trial project management.
Maintained subjects (600) enrollment for phases I-IVoncology study.
Performed query management including review, creation and resolution of case report forms.
Participated in internal and external team meetings, as necessary.
Co-ordinated site selection and pre-study activities to identify and evaluate potential investigators.
Assisted in development of patient enrollment strategies Assisted in database setup including document creation and review data entry screen.
Generated mock case report forms for internal review and training.
Maintained quality control of the data, project deliverables and closeouts.
Experience
10+ Years
Level
Senior
Education
Biology
Jr. Clinical Trial Associate Resume
Objective : Over 2 years experience as a Clinical Trial Associate at a CRO and over 1 year as a Systems Support Associate at a large pharmaceutical company Experience with Electronic Data Capture (EDC) and Clinical Trial Management (CTMS) systems Experience co-monitoring at clinical sites.
Skills : Software: Microsoft Office (Visio, Excel, PowerPoint.
Description :
Responsible for include, but are not limited to the following Direct contact with participating sites study personnel, as well as direct .
Assisted in reviewing medical coding for validity and completeness, as needed
Maintained communication with study sponsors and study sites on a daily basis (via phone and email correspondence).
Assisted study sites in completing initial study applications, annual review reports and close out reports.
Facilitated the regular upkeep of study Trial Master Files.
Responsible for maintaining the status of regulatory documents.
Provided continuous support to CRAs and Clinical Team Leaders (CTL) with the day-to-day administrations of assigned clinical studies.
Experience
2-5 Years
Level
Junior
Education
Bachelor Of Arts
Clinical Trial Associate III Resume
Objective : Project management, leadership development and organizational effectiveness professional with over 11 years of corporate experience within the Biotechnology industry. Expertise in strategy development, process improvement, organizational effectiveness, change management, training, program management, cross-functional project management and senior- leadership interaction.
Skills : Microsoft Office, Management, Project Management, Administrative Support, Program Management, Project Coordination.
Description :
Developed and maintained positive relationships both internal and external to project, including site personnel.
Participated in clinical study core team meetings, and record, issue and file minutes of study-specific meetings.
Supported the CPM in collection of pertinent Regulatory documents from initial trial start-up through trial close out.
Ensured central and site file documentation is appropriately tracked and filed, and support the CPM in ensuring that documentation complies with ICH/GCP, BSC and project specific requirements.
Supported the CPM in development and execution of clinical study contracts and budgets.
Reported relevant status updates/metrics to the study team as per study-specific requirements.
Supported the CPM in initiating and tracking IRB/EC submissions, approvals and renewals.
Experience
2-5 Years
Level
Executive
Education
Child Psychology
Clinical Trial Associate II Resume
Objective : To be apart of a team/organization which plans, organizes, and conducts clinical research studies. Would like to utilize attention to detail and ability to multitask and triage while being involved in all operational activities and management for new and/or ongoing clinical research trials.
Skills : Skilled with Microsoft Office, Excel.
Description :
Participated in the development and revision of documents and study support materials (homecare training manuals, homecare visit forms, etc).
Tracked progress of projects and identify appropriate actions to achieve target objectives.
Served as a point of contact for Sponsors and Investigator Sites participating in the study.
Reviewed documentation/source documents for completeness and accuracy.
Reviewed and verify invoices for study-related services.
Maintained study files and trial tracking systems.
Initiated improvements to enhance the efficiency and the quality of the work performed on assigned projects.
Experience
2-5 Years
Level
Executive
Education
Bachelor Of Science
Clinical Trial Associate I Resume
Objective : Clinical Development Department, the Clinical Trial Associate (CTA) will be responsible to support clinical and operational activities.
Skills : Ability to multi-task and think on your feet.
Description :
Assisted in reviewing medical coding for validity and completeness, as needed.
Provided exceptional front-line technical support and set-up assistance to international clinical clients through service testing and training .
Ensured all study documents are archived based on the appropriate guidelines/policy.Ordered clinical trial supplies.
Registered clinical site personnel for study specific training Modules through ePharma Supported investigator meeting .
Worked closely with Independent Review Boards (IRBs), both Central and Local, to ensure study sites remain in good standing.
Compared database entries (DataFax) to CRF to insure data entry quality.
Performed database lock activities for a Phase I-IV clinical trial study for oncology and psychiatric 1600+ patients with Alzheimer's disease.
Experience
2-5 Years
Level
Executive
Education
Biology
Assistant Clinical Trial Associate Resume
Objective : Highly qualified Clinical Trial Associate with experience in the industry. Enjoy creative problem solving and getting exposure on multiple projects, and would excel in the collaborative environment on which your company prides itself.
Skills : Project Management, Clinical Research, Microsoft Office, Microsoft Project, CRM, Salesforce, Nautilus LIMS, Connexus.
Description :
Maintained working knowledge of Company standards/SOP and FDA/ICN guidelines and regulations.
Received, reviewed, tracked/inventoried, and filed all documents pertaining to applicable clinical research studies.
Prepared, maintained, returned/archived project master files as applicable.
Performed project master file reviews as outlined in project specific plan.
Requested, managed, distributed and tracked study supplies.
Updated and maintained study-specific trackers and systems under direction of Project Lead.
Coordinated, provided set up, and attended project meetings including: internal, CRA, client meetings and presentations.
Experience
2-5 Years
Level
Executive
Education
Pharmaceutical Sciences
Clinical Trial Associate/ Specialist Resume
Objective : Gastrology, Hepatology including Pediatric Hepatology, Infectious Disease, Nephrology, Neurology, Oncology, Respiratory including Pediatric Respiratory, Rheumatology, and Vascular.
Skills : Good organisational abilities, Effective Communication Skills.
Description :
Facilitated vendor payments for purchase orders Liaise with outside vendors as directed to ensure study deliverables are met.
Supported investigator meeting preparation and collection/distribution of materials.
Centralized group and the SM/SSM for issues and status related to oversight of the IIP process.
Responsible for maintaining study information on a variety of databases (other than OC), tracking this information and preparing status reports as required.
Reviewed for data inconsistencies within and across various databases.
Managed clinical, regulatory and study-related documents; review documents for completeness, accuracy and compliance with protocol and appropriate regulations.
Assisted the Clinical Team in the preparation, handling, distribution, filing, archiving, and tracking of clinical documentation and reports.
Experience
2-5 Years
Level
Executive
Education
Bachelor Of Health Science
Assistant Clinical Trial Associate I Resume
Summary : Maintains current project paper files as well as records for off-site file storage for outsourced Trial Master Files Assist in the setting up of the files for all clinical studies and ensures relevant documents are filed for assigned projects.
Skills : Proficient In Written And Conversational Spanish, Database Management, Management.
Description :
Completed extensive Pfizer and company training that demanded superior knowledge of global standard operating procedures, good clinical practices and multiple clinical database systems.
Served as a point of contact for all necessary study support as well as a liaison between internal and external stakeholders.
Developed effective and productive partnerships with global teams and external vendors to ensure project goals and objectives were met, and workflow remained efficient.
Facilitated reporting and tracking of study budget spending, including processing study invoices.
Liaised with 1000 plus global sites to resolve regulatory and financial document discrepancies.
Maintained legal, regulatory, and financial documents on a variety of databases according to federal regulations and company policy, tracking this information and preparing reports as required.
Assisted in the early stages of study development and protocol initiation.
Experience
7-10 Years
Level
Management
Education
Bachelor Of Arts
Clinical Trial Associate Resume
Objective : Ambitious, dedicated, and compassionate professional with diversified experience aspiring to utilize skills and knowledge in a new and rewarding setting.
Skills : Effective Communication Skills, Excellent numerical, written and verbal communication skills.
Description :
Received, reviewed, tracked, and appropriately submitted all clinical trial documentation to project master file.
Prepared, maintained, and returned/archived project master files for assigned clinical trials.
Requested, managed, distributed, and tracked study supplies.
Updated and maintained trial-specific trackers and systems under direction of Project Lead.
Coordinated, set up, and attended project meetings including internal, client meetings, and presentations.
Provided administrative support for project teams including mass mailings, mass e-mail distributions, and newsletters per contract specifications.
Maintained working knowledge of the company's standards, standard operating procedures, and FDA/ICH guidelines and regulations.
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