A Clinical Study Coordinator manages clinical trials and assesses drug and medical device benefits and risks. Usual work activities are listed on the Clinical Study Coordinator Resume as – handling day-to-day activities, implementing policies, writing reports, interviewing and hiring staff, implementing policies, budgeting and organizing meetings; budgeting, overseeing the smooth running of clinical trials; collecting and analyzing data obtained from the research, administering questionnaires, monitoring research participants to ensure adherence to study rules, and maintaining a detailed record of studies as per FDA regulations.
Those seeking this career must embrace the following skills – the ability to adhere to ethical standards, prior work experience in clinical care or healthcare; analytical mindset, exceptional mindset, outstanding written and verbal communication skills, and healthcare management. A college degree in a relevant field is required. Case management expertise and ethics are crucial.
Headline : To obtain a position in the Clinical Study Coordinator where I can utilize my skills as detail oriented, motivated, strong communication, analytical and organizational skills for clinical research and medical advancement.
Skills : Basic Research, Clinical Research.
Description :
Reviewed and comprehend all study protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
Conducted and/or participated in the informed consent process/discussion with research participants, including answering any questions related to the study.
Obtained appropriate signatures and dates on forms in appropriate places per the research SOP.
Assured that amended consent forms are appropriately implemented and signed respectively.
Screened subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility accurately.
Facilitated and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Coordinated patient visits as assigned by research manager.
Experience
5-7 Years
Level
Executive
Education
GED
Clinical Study Coordinator Resume
Headline : Improving clinical trials by ensuring studies are conducted, recorded and reported in accordance with protocol, FDA, ICH-GCP, standard operating procedures (SOPs) and all other appropriate regulatory requirements. Aiming to widen my experience and knowledge in the field of clinical research with the goal to promote healthy clinical research by safeguarding the rights and welfare of the trial patients.
Skills : Clinical Research, Physician, Clinical Trials, Medical Affairs, Medical Case Evaluator, Reviewer, Physician.
Description :
Performed venipuncture to collect blood samples per the protocol.
Processed blood samples per the protocol and lab manual guidelines for each study.
Earned fast-paced promoted to manage clinical research operations and a 52-week, randomized, double blind, multi-site, parallel-group Phase III-B clinical trial for Astra Zeneca that compared the long-term safety of two asthma medications.
Recruited and enrolled study subjects.
Prepared accurate documents and reports.
Implemented study protocols.
Increased productivity for the research facility by 90%, reduced patient wait times and drove up retention through proactive process analysis and improvement.
Experience
5-7 Years
Level
Executive
Education
G.E.D
Clinical Study Coordinator Resume
Summary : To obtain a challenging Clinical Study Coordinator position in the pharmaceutical industry or health related field that provides ample opportunities.
Skills : Meditech, Microsoft, Spanish.
Description :
Supported operational implementation of clinical development trials.
Assisted with operational aspects of assigned protocols.
Processed investigator budgets and payments; tracked same expenditures.
Assisted with investigator meeting planning and conduct.
Informed consent review; investigator site recruitment; central file audits; data entry.
Provided study management support for all Study Management areas within CDMA-NA Clinical Operations.
Utilized advanced computer proficiency in a variety of Clinical Study databases and software applications.
Experience
7-10 Years
Level
Management
Education
Master Of Business Administration
Clinical Study Coordinator Resume
Summary : Clinical Study Coordinator, acting in the role of a school psychologist under supervision with a private practice. I conduct psychoeducational assessments in the schools to determine if children are eligible for special education services. I also have a counseling case load, facilitate a grief group, and provide risk assessments and crisis intervention as needed.
Skills : Power Point, Outlook, SPSS, Stata.
Description :
Created and coordinated advertisements for study recruitment.
Recruited and enrolled patients into research studies.
Screened referrals for potential study subjects.
Ensured all study inclusion and exclusion criteria were met.
Obtained informed consent from subjects.
Accurately documented patient rating scales and all required procedures in compliance with the study protocol.
Coordinated scheduling of required tests, procedures, and admissions required for study implementation.
Experience
10+ Years
Level
Senior
Education
MS
Clinical Study Coordinator Resume
Summary : A driven and compassionate aspiring Clinical Study Coordinator professional, seeking a position to put my proficient computer skills into practice, as well as be part of a thriving company where I can grow both professionally and personally. I am friendly, loyal, and a self-starter that can work with minimal supervision.
Interacted effectively within interdisciplinary teams.
Utilized knowledge of clinical research processes.
Restructured and revitalized clinical study operations after taking over for a study coordinator with over 11 years of experience.
Served as Research Coordinator of Phase III and IV clinical trials for various psychoactive substances and acted as the primary contact for the sponsor.
Included coordinating all aspects of the clinical trial from study start up through close-out with the monitor.
Experience
10+ Years
Level
Senior
Education
M. A. In Counseling
Clinical Study Coordinator Resume
Headline : Secure a permanent Clinical Study Coordinator position in order to utilize my experience within a hospital environment. Detail to accuracy, ability to adapt in a fast paced atmosphere; along with my experience can help maintain the professional reputation of the hospital. I am an effective team player that also works well independently.
Skills : Microsoft Office, ClinDex, Electronic Medical Records.
Description :
Coordinated and performed clinical practices on children who participate in the Wheals Study Inform patients or caregivers about study aspects and outcomes to be expected.
Monitored study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
Maintained required records of study activity including case report forms, drug dispensation records, or regulatory forms.
Communicated with laboratories or investigators regarding laboratory findings.
Performed specific protocol procedures such as interviewing subjects, taking vital signs, and performing pulmonary function tests.
Developed advertising and other informational materials to be used in subject recruitment.
Conferred with health care professionals to determine the best recruitment practices for studies.
Experience
5-7 Years
Level
Executive
Education
BA
Clinical Study Coordinator Resume
Headline : A self-motivated and goal-oriented biochemist with combined experience in Basic Clinical Research and Pharmaceuticals with strengths including: Managing and Coordinating Multiple Projects and Pharmaceutical Trials Experience in Phase II - IV Drug development Trials in Pharmaceuticals Scientific Writing, Statistical Data Analysis and Presentations.
Skills : Microsoft Office, Data Entry, Customer Service, Medical Records, Medical Terminology, Multi-Line Phone System, Management.
Description :
Coordinated a clinical study funded by the California Strawberry Commission.
Recruited, enrolled, and managed 24 subjects and screened over 200 potential subjects.
Directed and collaborated with Staff Research Associate, Graduate Student Researcher, undergraduate aides and General Clinical Research Center (GCRC) nurses and staff.
Completed IRB documents.
Completed specimen laboratory analysis for LDL oxidation (ELISA), glucose and lipid separation.
Prepared all meals and treatments for subjects in a metabolic kitchen according to study protocol.
Developed study-related advertising materials.
Experience
5-7 Years
Level
Junior
Education
Master Of Science
Clinical Study Coordinator Resume
Headline : As a Clinical Study Coordinator, responsible for Attending and participating in Investigator and staff meetings, Advising team regarding specific study assignments and timelines, Explaining and obtains informed consent, medical history and demographics; documenting in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety.
Skills : OR Experience, Coordinating Skills.
Description :
Managed the trial master files of various phase I-IV clinical studies.
Worked with Project Leaders/Sr.
Performed routine regulatory document preparation, distribution, receipt, inspection and tracking for assigned clinical trials.
Included collection and analyses of data to produce reports.
Analyzed dietary food records.
Participated in the development of study protocols including guidelines for administration or data collection procedures.
Prepared study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
Experience
5-7 Years
Level
Executive
Education
Master Of Public Health
Clinical Study Coordinator Resume
Objective : Clinical Study Coordinator with 2+ years of experience in Reporting and tracking adverse events (AE). Reporting serious AEs to IRB and sponsor, Documenting all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor.
Skills : Psychological Testing And Assessment, Including 16-PF.
Description :
Responsible for SWOG (Southwest Oncology Group) cooperative group studies' IRB submissions and maintenance.
Responsible for coordination of multiple pharmaceutical studies' regulatory submissions and maintenance including initial submissions, amendments, continuations and closures.
Coordinated and submissed of adverse events for the studies; both to Principal Investigators and IRB.
Maintained of Clinical Trials Database for the studies coordinated.
Monitored, coordinated, maintained and analyzed research data.
Collected data from patient charts.
Conducted all of the psychiatric rating scales and completed the patient's CRFs.
Experience
2-5 Years
Level
Executive
Education
MS
Clinical Study Coordinator Resume
Summary : Energetic, detailed, and focused professional with 13 years of experience in the health care arena. Self-starter as well as a valued team leader/member. Proven ability to multi-task challenging job responsibilities and maintaining balance in life.
Skills : Clinical Study Coordinator, Training Skills.
Description :
Led clinical coordinator in several double blind placebo controlled clinical trials.
Gathered documents and performing administrative tasks necessary to start a study at a site, screening patients for possible inclusion in a clinical trial, coordinating patient visits and follow through throughout a clinical trial, processing, storing, and shipping specimens, excellent interpersonal communication to work effectively with staff, patients.
Maintained regulatory documents.
Handled communications via fax, email, and telephone.
Maintained electronic data capture for all patients.
Consented and recruited individuals into drug and non-drug related clinical trials and coordinated multiple studies with over 80 or more participants.
Responsible for completing all of the laboratory procedures for all study subjects, resolving queries, and maintaining all of the regulatory documents.
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