The main duty of a Clinical Research Specialist is to provide clinical research expertise by participating in the designing and implementation of clinical research projects. A well-drafted Clinical Research Specialist Resume mentions the following core duties and responsibilities – developing objectives and designing research projects and proposals; formulating and conducting scientific experiments, and research results; evaluating and refining research strategies and recommending improvements and testing; proposing techniques to enhance research quality and team productivity, and developing and following standard operating procedures and adhering to company policies and safety guidelines.
To ensure success in this field, the person should have research-related expertise; knowledge of research principles, concepts, practices, and methods; excellent interpersonal and written and verbal communication skills; and strong analytical skills. The most common qualification includes a degree in science or a related field.
Headline : Seeking a position in Clinical Research as a Research Nurse/Coordinator or a Clinical Research Associate. Customer-focused and strong communicator with the ability to effectively interact with others. Quick learner with management potential.
Skills : Medical Terminology, Organized, Multi-Tasking, Detail-Oriented.
Description :
Experienced in both in-house and field PMA (e.g. 15 sites, 200+ patient) and 510(k) clinical studies.
Hands-on experience supervising clinical sites during PMA studies.
Trained practitioners on the use of products.
Designed case report forms (CRF).
Worked with sites to ensure study documentation was correctly completed and captured relevant information from each study.
Audited sites on a periodic basis to ensure conformance to protocols and proper data entry.
Cataloged the stored information in a coherent manner for future analysis.
Wrote parts of response letters to FDA questions in conjunction with Regulatory Affairs.
Experience
5-7 Years
Level
Executive
Education
MS in Nursing
Clinical Research Specialist Resume
Summary : Experienced medical and pharmaceutical professional with a proven track record in creating and implementing innovative methods to engage in clinical research and perform functional operations. Demonstrated a talent to effectively lead cross-functional teams to comply with all regulatory guidelines and achieve organizational goals.
Skills : Medical Terminology, Microsoft Office.
Description :
Established and retained functional relationships with sponsors to effectively communicate the progress of clinical trials and patient/study-related issues.
Scheduled and coordinated site evaluation visits.
Conducted and facilitated training sessions; ensuring proper documentation and archiving of documents and materials.
Pioneered all recruitment processes, assuring full compliance with governing consent regulations while also adhering to institutional protocols.
Confirmed eligibility prior to enrolling any study patient - verify source for all criteria, time frames, and windows.
Recorded, document, and report protocol deviations.
Assisted with audit preparation and follow-up.
Extracted data from source documents and complete CRFs.
Reviewed incoming subject SAE information.
Experience
10+ Years
Level
Senior
Education
Bs in Medicine and Surgery
Clinical Research Specialist Resume
Headline : Meticulous clinical research professional with 4 years experience in oncology research including bone marrow transplant, breast, and ovarian. Highly organized, self-motivated, and proficient with computers.
Skills : Clinical Research, Business Development, Strategic Planning, Communications, Heath Education, Microsoft Office.
Description :
Designed a clinical trial scorecard to report and track quality metrics for the coronary and renal denervation clinical department.
Fully accountable for trending metrics for the entire global department and developed action plans when quality fell below expectations.
Performed gap analysis of SOPs across multiple geographies to create a universal SOP that could be implemented across all geographies while still being compliant with the local and international clinical regulations.
Managed 38 sites in long-term follow up of a coronary stent study and coordinated closeout activities for all 100 sites.
Performed on-site qualification visits to provide feedback to management regarding site selection.
Created a clinical project cost analysis tool that was implemented across the entire department.
Assisted with annual progress reports as well as a final study report for another trial.
Performed site initiation visits and on-site study training, as well as coordinated all activities at investigator sites.
Experience
5-7 Years
Level
Executive
Education
MS in Health and Exercise Science
Clinical Research Specialist Resume
Objective : Clinical Research Specialist is responsible for the design, execution, and analysis of clinical research studies. This includes preparing and managing study protocols, conducting patient recruitment for clinical trials, maintaining the database of trial participants, and monitoring the progress of trials.
Skills : Microsoft Office, Detail Oriented, Customer Service.
Description :
Recruited and screened subjects for Maryland's Healthy Transitions Initiative (HTI).
Collected information provided by provider organizations in order to review consents and schedule interviews.
Scheduled and conducted interviews and recorded responses concisely and accurately using manual methods.
Performed clinical research including data collection, data entry, data verification, data analysis, compliance, and clinical relevance of data.
Presented information orally to internal and external parties.
Prepared for internal audits conducted by the IRB or sponsors-monitors.
Conducted library research and contributed to the preparation and writing of research findings for publication of journal articles.
Performed administrative duties such as providing training and guidance to other students or clinical staff and maintained accurate and timely study activity expense logs.
Assisted the Principle Investigator with the management of budget and financial reporting.
Experience
2-5 Years
Level
Junior
Education
Ph. D. in Communication & Culture
Clinical Research Specialist Resume
Headline : Seeks to secure a position where previous experience and education will enhance in a career-oriented position. Organized problem solver who creates solutions. Maintains a flexible schedule and responds quickly to emergency service calls.
Skills : Phase 1- 4 Clinical Trial Management, Microsoft Office, Microsoft Project.
Description :
Responsible for the resourcing, supervision, and evaluation of regional Clinical Research Associates (CRA).
Worked closely with the management team to ensure adequate staffing.
Reviewed and approved 80 timesheets for all Clinical Research monitoring staff.
Interviewed potential new employees.
Assisted with training and orientation of new employees.
Managed studies in association with the lead CRA to ensure all project expectations and milestones are met.
Worked with all departments to improve and streamline SOPs and Work Instructions to ensure adherence to GCP.
Participated in business development and study startup.
Conducted all types of site visits to assist with new hire mentoring and assist during staff changes for temporary site management.
Experience
5-7 Years
Level
Executive
Education
BS in Health Administration
Clinical Research Specialist Resume
Objective : High-energy business planning and strategy consultant with strong critical thinking, problem-solving, and change management expertise: Strategic, operational, and scenario planning & monitoring Process improvement and product training Focus group and review board moderation Launch and business simulation workshop facilitation.
Skills : Healthcare, Informatics, Presentation, Problem Solving, Customer Service, Fast Learner, Internet Research, Knowledge Of Medical Terminology, Training, Teaching.
Description :
Coordinated the lead site of a multisite clinical research study "Markers for the Identification, Norming, and Differentiation of TBI and PTSD" (MIND).
Maintained regulatory binders and participant data, collaborated with on- and off-site staff, and maintained regulatory compliance for staff.
Recruited veterans across the nation and organized lengthy site visits.
Administered CAPS interviews, collected and prepared blood, urine, and saliva specimens for storage, shipment, and analysis, and created and maintained a database for efficient data entry, storage, and analysis.
Coordinated all recruitment, study administration with various staff, data entry and storage, at the lead study site, as well as collaborated with two other WRIISC study sites.
Created and maintained database using both Microsoft Excel and Microsoft Access 2007 for efficient data entry, storage, and analysis.
Collected data and assisted with manuscript writing and publishing.
Navigated DC Veterans Affairs Medical Center administrative tasks for shipping, scheduling appointments, paying for visits, and working with clinicians in various disciplines, as well as using electronic medical records onsite (CPRS).
Experience
2-5 Years
Level
Junior
Education
BS in Nursing
Clinical Research Specialist Resume
Objective : Effective at training fellow lab members in advanced laboratory techniques, experimental methods, and instrumentation. Capable of effective written, oral, and visual communication skills in both English and Spanish.
Skills : Bilingual, Dual Background, Global Experience, Computer: Word, Excel, Powerpoint, Ms. Project, Inform, RAVE, Clinical Trial Management System.
Description :
Oversaw the studies conducted and reported to the Project Manager.
Assisted in the design and implementation of the Monitoring Plan.
Assisted in startup activities including regulatory authority submission Performed different types of monitoring visits e.g.
Ensured REC / IRB approval has been obtained.
Prepared and reviewed consent forms, as required Clinical Trial Lead Responsibilities.
Supervised a team of CRAs & CTAs (12 in total) in assigned territory.
Supported GTL (Global Trial Lead) in ensuring all operational trial deliverables are met according to timelines, budget, operational procedures, and quality standards.
Managed the trial master file in the assigned territory Managed trial allocation and coordination of activities leading to site initiation.
Supported Medical Lead by generating periodic data cleaning reports as assigned.
Experience
2-5 Years
Level
Junior
Education
PhD In Anatomy & Cell Biology
Clinical Research Specialist Resume
Objective : Clinical Research Specialist now seeks to obtain a position as a clinical research professional at a pharmaceutical/ clinical research/ healthcare organization to expand existing skills and professional growth in the field of clinical research within the healthcare industry. Dedicated/self-motivated work ethic and strives to consistently exceed expectations on deadlines and duties.
Skills : Macintosh Computers, WordPerfect.
Description :
Developed multiple site start-ups for a newly formed site management organization.
Trained research coordinators in all the sites.
Prepared/developed research site SOPs and source documents.
Responsible for budget development and negotiation of industry-sponsored clinical trials for all sites (serve as the central contract/budget management center).
Prepared and attended site qualification and initiation visits in the different sites.
Facilitated the contractual phase of all clinical studies by working in close collaboration with the legal department Approve/Reconcile invoices for all the expenses incurred by the execution of the clinical trials in the sites.
Developed a registration system for research patients to ensure proper billing and avoid issues of non-compliance.
Participated in corporate meetings in support of the company's progress regarding productivity, clinical excellence, and business metrics.
Experience
2-5 Years
Level
Junior
Education
PhD in Public Health
Clinical Research Specialist Resume
Summary : Seeks to find an entry-level position with the opportunity for growth. Possess substantial laboratory experience in molecular biology, immunology, microbiology, and has significant clinical lab experience.
Skills : Sales, Medical Devices.
Description :
Engaged with Key Opinion Leaders (KOLs)/customers for the development and management of a global registry designed to collect safety, effectiveness, and outcomes data for Acclarent's commercially approved balloon sinus dilation system.
Trained physicians, other medical staff, and Acclarent personnel on the proper use of Acclarent products.
Certified to work in the operating room environment and possess Reptrax, VCS, and Vendormate credentials.
Assisted with Principal Investigator Training meetings for clinical studies at sites.
Led the Otology clinical department through an FDA inspection, which resulted in no clinical findings.
Generated market data analysis reports assessing device efficacy, patient satisfaction, and overall health outcomes in order to identify improvements for products and/or treatment procedures.
Conducted research on newly identified adverse events and presented potential root causes and possible mitigation strategies to Research & Development and Quality team members.
Experience
10+ Years
Level
Senior
Education
MS in Global Medicine
Clinical Research Specialist Resume
Objective : Seeks to obtain a challenging managerial level position in clinical research that utilizes a unique combination of public health and business education and experience in an academic research setting to improve and enhance the success of an organization.
Skills : Teaching, Writing, Translating, Interpreting, Planning, Monitoring, Policy Development, Forms Design And Development, Program Design, And Evaluation.
Description :
Responsible for leading the population control enrollment team, significantly increasing control enrollment to 278 participants annually.
Involved in the recruitment of new study staff, in addition to their training and supervision of daily staff and study activities.
Oversaw all research operations in coordination with the Principal Investigator.
Performed quality control of collected data through regular monitoring and evaluation of study data and activities.
Managed administrative and regulatory aspects of the study including Institutional Review Board (IRB) submissions, sponsor communications.
Worked on fund requests for participant payments, the fulfillment of data requests from sponsors, and the development of study progress information for semi-annual and annual reports.
Worked closely with Principal Investigator to ensure budgeting, regulatory compliance, and regular data reporting were accurate and in line with study and sponsor needs.
Prepared regular reports and assembled findings for presentation to PI and study sponsor, and participated in regular sponsor site visits.
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