As a Clinical Scientist, the professional will analyze samples taken from the human body, including blood, urine, and other bodily fluids, and determine the diagnosis and treatment needed for the disease. A well-drafted Clinical Scientist Resume mentions the following duties and responsibilities – planning and organizing work in the clinical biochemistry laboratories; carrying out analyses on specimens of body fluids and tissues; performing clinical validation by checking abnormal results and deciding for further tests, auditing the use and diagnostic performance of tests, developing new and existing tests, devising and conducting basic or applied research; and liaising with clinical and healthcare staff to prevent disease and keep patients healthy.
While the duties vary based on the clinical setting, the needed skills to execute them are universally the same and include the following – laboratory skills, the ability to plan and do research; an analytical and investigative mind, good IT skills, a willingness to keep updated with the latest scientific and medical research in clinical biochemistry, and meticulous attention to details. A master’s degree in a relevant field is commonplace among job applicants.
Objective : 17 years product development experience, including 9 years direct IVD medical device experience Strong writing and quality control review skills, including protocols and clinical study, reports Strong GCP knowledge Effective organizational, communication and time management skills Goal-oriented, self-motivated with attention to detail and leadership ability Ability to work well both independently and in team environment Six Sigma Green Belt Certified Clinical Research Associate (ACRP).
Skills : Monitoring, Project Management, Technical Writing, Standard Operating Procedure Development, Source Data Form Development, Implementation Of GCP Training Program.
Description :
Managed multiple US and International (EU and S.
Designed clinical strategies, clinical study protocols, study management plans, monitoring plans, investigators brochures, study forms, and training materials.
Conducted scientific literature searches and competitive product literature and prepared summaries for the technical team.
Prepared abstracts and posters for internal meetings and conferences.
Managed all aspects of vendors (CROs, central laboratories, suppliers of study materials (including custom materials), and specialty laboratories).
Identified, qualified, and trained principal investigators and clinical study sites.
Ensured compliance with current regulations in the US and EU including Safe Harbour, GCP, HIPAA, and Sunshine Act.
Experience
2-5 Years
Level
Executive
Education
GED
Clinical Scientist Resume
Objective : Experienced Clinical Scientist with approximately 13 years in global clinical trials experience from Phase I to III clinical drug and device studies. Worked as a Preclinical senior Research Scientist with an expertise in Drug Metabolism and Pharmacokinetics at GlaxoSmithKline for 26 years (6 years in Clinical Research).
Skills : Drug Safety, Pharmacovigilance, Dental Asistant, Dentist.
Description :
Reviewed of the trial subjects using study database like Clinical Data Review system, Discrepancy tool set, Status tracking utility, e-Clinical software application, and SAE reconciliation tool to validate the data from Medical Point of view.
Experienced in SAE Reconciliation Processes.
Performed many protocol reviews.
Monthly tracked and reported of study status to the Medical monitor.
Worked knowledge of company SOP, GCPs, ICH Guidelines and FDA regulations.
Reviewed & QC of documents in compliance with excellence measurement tool.
Participated in the collection, safety review, processing and reporting of adverse event data in compliance with applicable FDA and global regulations, standard operating procedures and guidelines.
Experience
2-5 Years
Level
Junior
Education
BS
Clinical Scientist Resume
Objective : To obtain Clinical Scientist position that maximizes my biomolecular research, cell biology and pharmacology background and experience.
Skills : Clinical Trial Management, Oversight Of External Vendors To Include CRO, Central Lab, Centralized Imaging, IXRS, Etc, Oversight Of Clinical Trial From Feasibility Through Completion Of Study Report And Study Completion.
Description :
Conducted and monitored clinical trials, coordinated communication with the sites.
Conducted site recruitment, selection, initiation, monitoring, and closeout duties at nationwide sites.
Trained site personnel in GCP and study protocols.
Participated in site management, budget creation, and project negotiation activities.
Maintained relationships with site investigators and reported data regularly with EDC (Electronic Data Capture) paradigms.
Completed clinical monitoring, clinical trial plan, and final clinical trial report.
Researched and wrote for clinical trial protocols, plans and reports.
Experience
2-5 Years
Level
Management
Education
B.A. In Biology
Clinical Scientist Resume
Headline : Responsible for performing a full range of laboratory tests from simple blood tests to more complex tests, and also Interpreting test reports and communicates findings to physicians.
Implemented, conducted, and monitored clinical trials which comprised of preparation and organization of documentation, selection, qualification, and closure of clinical trial sites, maintained relationships with clinical sites, testing sites, various investigators, and partners.
Duties involved selecting, qualifying, and/or closing sites, research and writing trial plans protocols and reports, daily monitoring of activities and communications regarding the conduct of clinical trials, coordinating contact with the sites, problem-solving, reporting and analyzing data, correspondence, and maintaining relationships with sponsors, investigators and the sites domestically and globally for multiple time zones.
Reviewed data and document verification to ensure accuracy and records managed according to local, federal, and international compliance and patient privacy.
Coordinated with team members and provided support regarding technical problem solving and resolution to key issues for continuous process improvement efforts.
Prepared and assembled agendas, minutes, documents including protocols, amendments, and trial reports.
Maintained clinical trial and regulatory files and verified for completion for submission to sponsoring and/or for regulatory or premarket approvals.
Assisted with the preparation and conduct of technical reviews to launch and/or close trials.
Experience
5-7 Years
Level
Executive
Education
M.S. In Biology
Clinical Scientist Resume
Headline : Seeking a Clinical Scientist position with an outstanding career opportunity that will offer a rewarding work environment along with a winning team that will fully utilize management skills.
Skills : Clinical trials, Data collection, and Management, Statistics.
Description :
Participated, organized, and led teleconferences, WebEx meetings and traveled to sites domestically and internationally as needed for initiation, monitoring, and/or closure.
Maintained clinical trial files and made sure files were complete for FDA audits.
Ensured data integrity with regulatory guidelines and FDA requirements.
Provided support to the Drug Safety and Risk team including coaching, case escalations, mentoring on technical matters pertaining to Pharmacovigilance, Drug Safety and REMS Reviewed adverse event information received for completeness and consistency, initiated case follow-up activities/AE query management, and independently generated narratives in accordance with department processes.
Prepared clinical study contracts/agreements and confidentiality agreements liaising with corporate and site legal groups (international and the US).
Worked closely with other functional areas within the Research and Development Departments (clinical operations, data management, biostatistics, clinical pharmacology, preclinical) to facilitate the execution of clinical trials.
Developed and cultivated relationships with external partners such as clinical investigators, clinicians, scientists, and vendors.
Experience
5-7 Years
Level
Executive
Education
GED
Clinical Scientist Resume
Objective : Experienced Clinical Scientist professional with solid knowledge of clinical research operations and management. Proven ability to manage multiple clinical trials, staff, and to meet critical deadlines.
Skills : Microsoft Office, Multitasking, Researching.
Description :
Reviewed and interpreted medical data and clinical trial data and come up with conclusions.
Assisted Medical Monitor with a review of the safety and efficacy data (DSMB, PV, coding when appropriate).
Collaborated with the clinical development team on the review, analysis, and interpretation of study results, including exploratory endpoints and assure appropriate data review and accurate data reporting Provide scientific input to protocol development including literature review to support study rationale, determination of the primary, secondary and exploratory endpoints, and ensuring the appropriate safety parameter are met Support the Medical Monitor with the development of program documents, including the clinical sections of various regulatory documents such as clinical study reports, investigator brochures, DSURs and assist of regulatory submissions to support product approvals.
Participated in the identification of appropriate external investigators and consultants.
Reviewed patient consent forms and provide feedback.
Assessed accuracy of clinical data in clinical documents.
Read and interpret scientific and medical literature for use in clinical documents and to assist clinical team decision making.
Experience
2-5 Years
Level
Junior
Education
Healthcare Administration
Clinical Scientist Resume
Objective : Responsible for Ensuring safety, security, and the environment in all aspects of the daily activities and any potential safety hazards are addressed and corrected immediately.
Conducted data review of study data for safety to support an FDA submission.
Primary point of contact for site personnel to resolve any study-related issues.
Wrote narratives for adverse events to be included in clinical study reports.
Routined contact with sites to answer study-related questions, ensure subjects remain in visit windows, and reinforce protocol compliance.
Reviewed monitoring reports and followed up with Clinical Research Associates regarding outstanding issues as well as assist with resolution.
Reviewed study database and data listings to safety and to resolve data discrepancies, monitor adverse events, and report trends.
Participated in Study Team meetings as clinical study team representative to provide clinical input.
Experience
2-5 Years
Level
Executive
Education
Bachelor of Science
Clinical Scientist Resume
Objective : Clinical Scientist Professional with a diverse background in both research and development and quality and compliance. Experience in all clinical phases (I-IV) in various clinical roles. Highly motivated individual with the ability to rapidly adapt to high-pressure situations. Ability to effectively bring projects to completion both independently and in a team environment.
Prepared specimens for analysis and organizes tests to be performed.
Conducted analysis of dried blood spots or body fluid to determine the presence of normal and abnormal components.
Reviewed test results, maintains legible work records, and enters findings into the laboratory information systems.
Performed routine preventative maintenance on instruments and equipment according to established schedule and procedure
Verified proper instrument function by checking and calibrating lab instruments and documents data.
Recorded on instrument log any repairs, replacement and maintenance performed on laboratory instruments.
Prepared and properly labeled reagents required for laboratory testing.
Experience
2-5 Years
Level
Executive
Education
Bachelor of Science
Clinical Scientist Resume
Summary : High-energy, proven Clinical Scientist with a rare blend of technical competence and project management skills, who demonstrates the ability to execute initiatives to effect results. More than 10+ years of in-depth experience in design, build, and research development in biotechnologies with acumen in increasing quality and efficiency.
Designed and led clinical studies to support regulatory submissions for multiplex PCR-based diagnostic detection kits.
Produced FDA Query-submission documents and addresses FDA comments in written and in-person communications.
Developed sponsor's protocols and study procedures in accordance with ICH Good Clinical Practices, other applicable regulatory requirements for conducting clinical performance evaluations, and FDA guidelines.
Evaluated the capabilities of, and establish agreements with, international laboratories for the execution of pilot and pivotal clinical studies.
Coordinated the acquisition and delivery of study materials to study sites.
Initiated, trained, and monitored (remotely and on-site) study sites.
Managed and supervised one research assistant.
Experience
10+ Years
Level
Senior
Education
GED
Clinical Scientist Resume
Objective : Highly qualified Clinical Scientist with experience in the industry. Enjoy creative problem solving and getting exposure to multiple projects, and I would excel in the collaborative environment on which your company prides itself.
Skills : Clinical Skills, MS Office, Training Skills.
Description :
Coordinated and managed the process of planning, conducting, and reporting of clinical trials in adherence with the corporate SOPs, GCP guidelines, and Guideline for Clinical Development (GCD) comprising both the Clinical Monitor Local (CML) and Research Associate (RA) function.
Provided leadership and expertise to the Research Associate group members regarding their role in key clinical research processes.
Ensured that the study protocol and related documents are available for study initiation; identify and select investigators; calculate timelines and resources for local use.
Managed a local trial team; participate in investigators meetings and CRA training.
Monitored local trial progress to ensure that GCD timelines are met.
Ensured high quality and timeliness of the clinical trial and final study report by supervising CRO and/or CRA activities, reviewing ongoing safety data, assuring the study is conducted according to local and international standards and SOPs.
Acted as a training resource to the RA group at large.
Assisted in the relative distribution of RA workload to ensure both study success and personal growth/development.
Conducted six global trials in Oncology and Pediatric Oncology & one global trial in Cardiology & one global trial in Respiratory/Immunology.
Creating an account is free and takes five seconds.
You'll get access to the PDF version of this resume template.
Choose an option.
Sign up with Google
Sign up with Facebook
Sign up with Linkedin
This helps us make sure you're human and prevents spammers from abusing our services.
By continuing, you agree to our Privacy Policy and Terms.
Unlock the Power of Over 10,000 Resume Samples.
Take your job search to the next level with our extensive collection of 10,000+ resume samples. Find inspiration for your own resume and gain a competitive edge in your job search.
Get Hired Faster with Resume Assistant.
Make your resume shine with our Resume Assistant. You'll receive a real-time score as you edit, helping you to optimize your skills, experience, and achievements for the role you want.
Get Noticed with Resume Templates that Beat the ATS.
Get past the resume screeners with ease using our optimized templates. Our professional designs are tailored to beat the ATS and help you land your dream job.
