A Clinical Trials Coordinator manages clinical trials and assessing the medical device and drug’s benefits and risks. Some usual work tasks are listed on the Clinical Trials Coordinator Resume as – handling daily activities, writing reports, budgeting, interviewing and hiring staff, organizing meetings, overseeing the smooth running of clinical trials; collecting and analyzing data obtained from the research, managing research budgets, administering questionnaires, adhering to research regulatory standards, participating in subject recruitment efforts, ensuring that the necessary supplies and equipment for a study are in stock, and maintaining detailed records of studies as per FDA guidelines.
Qualifications required for this role include – financial skills, accuracy, healthcare management, prior work experience in healthcare, analytical mindset, attention to detail, exceptional interpersonal skills, outstanding written and verbal communication skills, and willingness to learn and self-educate. An Associate’s degree in Nursing or a related field is commonplace among job applicants.
Headline : To use acquired knowledge and experience to efficiently monitor clinical trials by enforcing ICH-GCP guidelines, executing policies and enforcing standard operating procedures, in order to provide exemplary results and uphold the integrity of clinical research.
Skills : Microsoft Office, Remote Monitoring.
Description :
Provided leadership and training for all multi-centered clinical research activities, primarily focusing on investigator-initiated phase 1 and phase 2 clinical trials.
Trained participating sites on all activities related to the research project such as eligibility criteria, enrollment instructions, reporting requirements, and monitoring plans.
Oversaw participating institutions to ensure that research and protocol activities comply with organizational guidelines and regulatory standards for multi-centered studies.
Developed educational in-services in addition to policies and procedures for the management of multi-centered studies.
Acted as a liaison for facilitating grants, contracts and financial tasks for multi-centered clinical research projects.
Developed, initiated, and supported clinical studies under the supervision of principal investigators.
Participated in the development of databases to use as the coordinating center.
Experience
5-7 Years
Level
Executive
Education
GED
Clinical Trials Coordinator Resume
Objective : Clinical Trials Coordinator with 3 years of experience in Preparing SAE and query summary reports for the CRAs prior to site visits, Reviewing data audit discrepancies provided by CRAs following site visits prior to submitting visit report to the sponsor.
Skills : MS Office, Clinical Skills.
Description :
Managed and support, travel itinerary, expense reports/purchase orders and other related activities for: Thomas Provencher, Senior Director of Global Monitoring, Christopher Brett, Senior Director of Global Trial Management and Monitoring and Peggy Zavala, Associate Director of Clinical Monitoring.
Supported study teams in administrative tasks and logistics (i.e. expenses, travel arrangements, meeting set-up including investigator meetings).
Managed study material and study supplies, as applicable Create and maintain Study Document Shared Locations for assigned study(ies) on the Central Repository File and maintain the study administrative files locally and send original documents to central TMF.
Supported Health Authority inspections and CQA audits as required Maintain and update data as appropriate in study management tools including CTMS, National Clinical Trial Databases, etc.
Provided general administrative and coordination support to the clinical operations department and the development and continuous improvement of departmental procedures.
Organized/maintained administrative activities/systems to support department members including compiling, analysis, tracking, filing and other functions as required.
Opened, sorted and distributed mail, fax documents, keep files, order office supplies and maintain supplies.
Experience
2-5 Years
Level
Junior
Education
Bachelors
Clinical Trials Coordinator Resume
Headline : As a Clinical Trials Coordinator, responsible for Assisting in the preparation of eligibility checklists, protocol abstracts, and protocol code lists as required for new or amended CTMS monitored protocols.
Skills : Microsoft Office Suite, Recruiting, Recruiting, Management, Medical Terminology, Medical, Customer Service, Customer Service, Problem Solving.
Description :
Coordinated Clinical Trials for biological specimen repository Performed duties of Inventory Manager and Inventory Technicians in their absence.
Interfaced with scientists and doctors in order to ship and deliver needed specimens.
Shipped, received, tracked, inventoried and created monthly account reports for worldwide biological specimens for international and national medical studies for John Hopkins University, NIH, Human Genome Sciences, BioGen, Bioreliance, Life Technologies and other local research facilities.
Created Clinical Trial reports for senior management and clients detailing delivery specifications including temperature controls, timing and monitoring of biological specimens.
Designed and developed detailed spreadsheets.
Performed database analysis, database maintenance, inventory record entry and barcode creation for all samples.
Ensured record entry accuracy by other employees.
Experience
5-7 Years
Level
Junior
Education
GED
Clinical Trials Coordinator Resume
Headline : Motivated clinical trials associate who possess over eleven years of professional experience in pharmaceutical methodologies, research analysis, business management, conflict resolution and exemplary customer service seeking to effectively utilize my oral, written and communication skills to develop new skills both within and outside of my academic and professional specialization.
Skills : Microsoft Office, Electronic Medical Records, Phlebotomy, Medical Terminology, Data Entry, EKG, Research, Vital Signs.
Description :
Assistant to the General Manager Conducted day-to-day execution of clinical research protocols including obtaining informed consent, completing study procedures, and dispensing, accounting for study drug, and documenting drug compliance.
Responsible for recruiting prospective research subjects for clinical trials.
Responsible for clinical communication with central and local IRBs and maintaining ethical approval for studies, from initial study approval through study amendments, annual continuations, and finally termination.
Documented and conducted appropriate correspondence regarding adverse events, including multiple severe adverse events.
Responsible for clinical tasks including venipuncture, vital signs, body measurements, ECG, and Produced kits for research sample collection and storage in environments without refrigeration, computers or Internet access.
Responsible for 20,000+ entry database of human tissue samples including daily intake, processing, diagnostics and sample retrieval.
Worked with other interns in extensive data-mining operation to create a complete and accurate computer database of all extant research patients and samples.
Experience
5-7 Years
Level
Executive
Education
Bachelor Of Science
Clinical Trials Coordinator Resume
Objective : Experienced research project manager and clinician with expertise in designing and implementing innovative programs and studies aimed at improving health and human service outcomes across diverse populations.
Skills : Implanted Port Access And Flush, Dressing Change.
Description :
Initialized Start-up procedure for new trials and develop pricing of new Clinical Trials tests.
Generated Cerner Millennium Migration Authorization Code (MAC) request for upcoming trials to LIS department.
Updated or wrote new procedures for upcoming trials and In-Service staff regarding those procedures.
Performed internal and external audits and work with different departments head for a corrective actions plan.
Ensured compliance with corrective action and preventive action plan (CAPA) throughout the laboratory.
Generated CORE PICG monitor, monthly metrics and statistics for Clinical Trials.
Reviewed Status report, Correction report, Exception report and QC report and follow-up accordingly.
Experience
2-5 Years
Level
Executive
Education
MS
Clinical Trials Coordinator Resume
Headline : Providing backup support to the Senior Data Management Coordinator for the following Tracking severe adverse events (SAEs) reported to CTEP AERS using the CTMS SAE Tracker and/or system updates. Interface with site personnel regarding CDS guidelines as related to reporting SAEs.
Skills : Planning Skills, Coordinating Skills.
Description :
Collaborated with Clinical Research Organization (CRO) to complete site initiation, interim monitoring, and close-out visits.
Participated in Investigator meetings and responded to CRO inquiries.
Responsible for completing and submitting required regulatory documents including CRF's and SAE's.
Reviewed contract reimbursement for services outside of standard care and submitted budget for approval, assuring coverage of trial-related expenses.
Identified prospective trial participants and followed through on all screening requirements, consent forms, and enrollment.
Educated staff on study requirements and patients on responsibilities as participant.
Effectively coordinated patient treatments, follow-up visits, and radiology and lab tests while assuring compliance with protocol.
Experience
5-7 Years
Level
Executive
Education
GED
Clinical Trials Coordinator Resume
Objective : To work in a Clinical Trials Coordinator position that gives me personal and professional satisfaction using my background and skills in clinical research.
Skills : Excel, PowerPoint, Lanier Dictation, Meditech, FoxPro, Etc.
Description :
Overall researched skills included accurately updating and maintaining the regulatory documentation for clinical studies within project timelines from start-up through closeout.
Submitted new studies, amendments, and yearly updates to the Institution Review Board (IRB).
Assured accuracy of study binders throughout the study with respect to protocols, amendments and consent forms.
Populated site signature delegation logs for each study and obtained appropriate staff signatures.
Performed ongoing QA of documents relative to the study trials.
Created, edited, and updated source documents appropriate to each protocol and amendment.
Cross-trained as backup data coordinator to enter patient demographics, visit schedules, and procedures.
Experience
2-5 Years
Level
Executive
Education
GED
Clinical Trials Coordinator Resume
Objective : Performing study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site.
Skills : Project Management, Records Management, Clinical Research, Volunteerism, Microsoft Office.
Description :
Coordinated of Phase II-III clinical trials in several European countries as part of international studies.
Coordinated in Spain of International Phase III trials and Observational, Phase IV studies.
In charged of the data management team (Data Reviewers and Data Entry Clerks) to coordinate CRF review, double data-entry, congruency checks.
In charged of the company's IT systems.
Designed of the company's network.
Designed and programmed of databases used for project management, business development and data-entry databases.
Monitored - extensive experience in Spanish and European Hospitals.
Experience
2-5 Years
Level
Executive
Education
MS
Clinical Trials Coordinator Resume
Summary : Dedicated and cross-functional Clinical Trials Coordinator professional with solid proficiency and substantial experience in providing and coordinating surgical care, outpatient care, outpatient surgery, and clinical trials. Dependable and proactive team player recognized for achieving positive results in a fast-paced work environment both inside and outside the Nursing arena. Solid writing and interpersonal skills.
Skills : Clinical Skills, Designing Skills.
Description :
Prepared pre-study subjects, discuss studies in depth with the eligible patients, prepare all source documents and work closely with study sponsors to assure data quality and regulatory compliance.
Taken medical histories, perform clinical assessment for adverse events, determine dose limiting toxicities and evaluate tumor response under supervision.
Maintained screening logs, preparing patient calendars, capturing data both electronically & on paper, answering queries and reporting serious adverse events to sponsors & institutional review board (IRB) along with conducting weekly team meetings and journal club discussions.
Reviewed research study protocols, Design and manage nursing implementation guidelines regarding protocol activity and patient care, provide nursing education, training and orientation to the clinical trials unit.
Worked with appropriate departments to coordinate patient care as well as proper protocol implementation.
Created and provided appropriate treatment visit types related to each protocol.
Additionally handled IRB submission and reporting, adding value to coordinator role.
Experience
7-10 Years
Level
Management
Education
MS
Clinical Trials Coordinator Resume
Headline : Highly qualified Clinical Trials Coordinator with experience in the industry. Enjoy creative problem solving and getting exposure on multiple projects, and I would excel in the collaborative environment on which your company prides itself.
Skills : Clinical Skills, Leadership.
Description :
Responsible for recruitment, consenting, and scheduling of subjects for two large NIH funded clinical trials; setup and maintenance of clinical trial postings on Clinical Trial.gov; multi-focal data collection of medical device focused clinical trials; and financial & operational management of the laboratory.
Effectively collaborated with the research team in the development & maintenance of a complex double-blind study protocol and outcome metrics on clinical trials focused on medical device delivery and behavioral training.
Ensured compliance to IRB protocol at all stages of the research by owning continuous reviews, accurate documentation, and writing amendments.
Led the scheduling of subjects involving multiple visits and double-blinding with four Audiologists.
Enabled comprehensive, accurate data management by designing, implementing and managing multiple databases.
Recruited subjects for carotid, SFA, and AV fistula stenting and consult on trial procedures, purpose, and processes.
Obtained Informed Consent forms to verify accuracy and confirm eligibility and advise patients on potential side effects.
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