Clinical Research Scientist Resume Sample
Zaria Mitchell
261 Lee Avenue,
Dallas,
TX
+1 (555) 743 7448
Work Experience
Senior Clinical Research Scientist
09/2015
-
PRESENT
Boston, MA
- Assist with clinical document preparation such as CSR, Patient narratives, etc. (writing, reviewing, amending and cross-functional facilitation as appropriate)
- Serve as a representative at scientific meetings and investigator meetings during which study designs/data are presented and reviewed
- Understand the principles and key foundations of clinical trial development and how they relate to the overall drug development process (i.e. randomization/stratification, control, blinding, selection of population, schedule of assessments, and study endpoints)
- Attain a working knowledge of Good Clinical Practices and International Conference on Harmonisation (ICH) guidelines in relation to clinical trial conduct and sound patient-focused practices
- To understand the role of the Clinical Research Physician (CRP)
- Work closely with the CRP and study team in making study-specific recommendations, providing clinical research expertise, presenting protocol-specific topics, and supporting the team at various therapeutic area conferences
- Gain extensive hematology/oncology therapeutic area and product-related expertise as well as engage in scientific/strategic discussions with internal and external thought leaders
- Partner with the Clinical Operations team to ensure scientific alignment with operational objectives while conducting the study
- Lead the study team in comprehensive clinical data review and analysis in conjunction with the CRP
Clinical Research Scientist
05/2012
-
05/2015
New York, NY
- At least five (5) years experience in clinical research and in handling subjects and patients in a clinical research setting
- Interact professionally in the medical environment
- Clinical and translational research projects and initiatives
- Assist principal investigator in the development and design of clinical and translational research to ensure value and feasibility of proposal
- Assist principal investigator in determining the specific goals or objectives to be attained
- Develop and maintain standard procedures and protocols to ensure the quality and integrity of research data to be obtained
- Identify and implement strategies to enhance collaboration between investigators and clinical or research scientists
Clinical Research Scientist Assistant
09/2007
-
03/2012
Dallas, TX
- Interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory, Early Development and Clinical Pharmacology, Medical Writing, Marketing, and Project Leadership
- Learn the role of the translational development laboratory components of a clinical trial through rotational activities
- Organize investigator’s start-up meeting and study site initiation meetings
- Understand and comply with company SOPs and GCP’s; contribute to continuous improvement in SOPs and local Working Practices
- Patient Recruitment: track enrollment, develop recruitment plans, and ensure procedures are in place for appropriate optimization of patients into the clinical trial. Manage patient recruitment strategies to increase patient randomization into the trial (eg investigator and research nurse meetings, update newsletters, advertising, letters to GPs)
- Design clinical studies for the purpose of assessing the performance of current products, of products under development or modification, and of competitors’ products
- Provide technical support to marketing personnel, answering customers’ questions, giving instruction in operation of Carl Zeiss Meditec products. Assist in the writing of users’ manuals and other publications
Education
Holy Names University
2002 - 2006
Science's Degree in Biological Science
Professional Skills
- Excellent written and verbal communication skills and interpersonal skills
- Professional writing skills and presentation skills
- Strong planning/project management skills (ability to develop short range plans that are realistic and effective in meeting goals)
- Strong writing skills to produce quality clinical documents, including final reports
- Strong computer skills, including proficiency with Microsoft Word, Excel and Powerpoint
- Excellent organization and tracking skills
- Excellent verbal, written, communication, and interpersonal skills
How to write Clinical Research Scientist Resume
Clinical Research Scientist role is responsible for clinical, research, training, medical, interpersonal, microsoft, mentoring, software, planning, scientific.
To write great resume for clinical research scientist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Research Scientist Resume
The section contact information is important in your clinical research scientist resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Clinical Research Scientist Resume
The section work experience is an essential part of your clinical research scientist resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous clinical research scientist responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular clinical research scientist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Research Scientist resume experience can include:
- Strong organizational skills and the ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business
- Effective oral and written communication and influencing skills
- Strong interpersonal, written communication, and presentation skills
- Proficient critical thinking, problem solving, decision making skills
- Entry critical thinking & problem solving skills
- Proficient critical thinking & problem solving skills
Education on a Clinical Research Scientist Resume
Make sure to make education a priority on your clinical research scientist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical research scientist experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Clinical Research Scientist Resume
When listing skills on your clinical research scientist resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical clinical research scientist skills:
- Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills
- Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)
- Strong decision -making and problem solving skills
- Strong planning and organizational, written and oral communication skills
- Strong preference for 3+ years of clinical experience or pharmaceutical industry experience
- Strong written and oral communication skills in multi-disciplinary environment
List of Typical Experience For a Clinical Research Scientist Resume
1
Experience For Senior Clinical Research Scientist Resume
- Demonstrates leadership capability as well as strong planning and organizational, written and oral communication skills
- Prior experience in clinical study protocol, informed consent, case report form design and clinical study report writing
- Marketing studies: Assist thought leaders in execution and reporting of university-driven trials needed to achieve product validation
- Excellent knowledge & hands on exp. supporting clinical sciences in Oncology
- Manages strategies for clinical trials using the product evidence strategy plan process (PESP)
- Develops good collaborations with scientists, internally and externally
- Three (3) years of relevant and productive research experience in clinical/population-based outcomes and health behavior research required
- Experience reviewing clinical data outputs
2
Experience For Clinical Research Scientist Gastroenterology Resume
- Basic understanding of biostatistics to allow effective interaction with biostatistics expert
- Partner with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access
- Previous experience in Clinical or Translational Development and proficiency in hematology and oncologydisease indications required
- A seasoned, experienced professional with a full understanding of how clinical trials are conducted
- Reporting, writing, and editing projects
3
Experience For Principal Clinical Research Scientist Resume
- Scheduling and facilitating protocol review meetings
- Working knowledge of regulatory authority interactions, and clinical regulatory guidance and requirements
- Understanding of clinical biostatistics and industry exp
- Tracking of local study approvals (IRB reviews) and patient enrollment
- Ensuring study drug supply; contribution to the clinical study reports; etc
- Planning & Documentation Development
4
Experience For Associate / Clinical Research Scientist Resume
- Understanding of GCP, ICH and regional/local regulations
- Understanding of functional and cross-functional relationships
- Conducts team meetings, drafting and sending routine correspondence (e.g., newsletters) and/or by presenting regular updates to senior staff
- Lead study level publication planning including manuscript writing and preparation
- Assist with review of ongoing summary data including: safety, primary efficacy variables, laboratory data, etc
- Development of study tools including guidelines and training materials for study sites and investigators
- Conduct review of ongoing summary dataincluding:safety, primary efficacy variables, and laboratory data
5
Experience For Clinical Research Scientist Assistant Resume
- Fundamental understanding of research funding process and culture
- Ph.D/M.S in Electrical Engineering, Biomedical Engineering, Physics or related field
- PhD in biomedical engineering, electrical engineering, computer science, or a related field
- Review clinical data, issuing queries in the electronic database, and following to resolution
- Collaborate with multifunctional teams to develop scientifically sound testing strategies, timelines and data to meet project goals and timing
- Responsible for protocol development and monitoring, data management, interpretation, reporting and study closure
- Apply machine learning and data mining techniques to healthcare data
6
Experience For Acpru Clinical Research Scientist Resume
- Review protocol documents including abstracts, text, and informed consent for relevant information
- Review and evaluate clinical protocol and translational research data, including laboratory correlates data
- Design clinical studies for the purpose of assessing the performance of current products, of products under development , and of competitors’ products
- Support of university-initiated independent projects: Manage incoming requests for assistance or support of independently initiated projects
- Clinical Literature: Interpret relevant clinical literature on CZM and competitive products in support of marketing teams
- Expert understanding of global clinical study design and drug development processes Knowledge of GCP and ICH Guidelines
- Contact with study coordinators at trial sites; tracking of local study approvals (IRB reviews) and patient enrollment
- Manage emerging technology
7
Experience For Clinical Research Scientist Onc Resume
- Thorough understanding of Human Subject protections and other research related regulations, biohazards and other environmental exposures as applicable
- Analytical thinking, able to present statistical methods and results to a variety of audiences, especially non-statisticians
- Agile, able to excel managing multiple projects and professional relationships
- Examine a technical problem from multiple perspectives, weighing alternatives with analysis and relevant data
- Understand clinical trial publications; understanding of disease
- At least one year in a CR&D capacity performing data review in oncology/hematology. (new proposal to add)
- Interact with large-scale data structures using SQL
- Plans and carries out all bioequivalence and phase I study protocol writing and quality control activities as well as all related documents
8
Experience For Associate Clinical Research Scientist Resume
- Abstract medical and scientific information and provide lay language versions when required
- Clinical and translational data analysis
- Review medical records to extract data points
- Ensure that the relevant clinical data is collected at designated stages in the treatment process
- Provide sound data analysis and interpretation of results for manuscripts and grant research plans
9
Experience For Clinical Research Scientist Hematology Resume
- Prepare data and information related to protocols, grants, abstracts, and manuscript submissions, as needed
- Compose technical reports, abstracts, slide presentations, spreadsheets, posters, and manuscripts for submission to corporate and federal sponsors, conferences, and scientific journals
- Proofread galley proofs of manuscripts nearing publication
- Utilize technical writing ability to compose and abstract medical and scientific information for preparation of written correspondence, reports, and protocols under the direction of study investigator
- Prepare specific protocol reports and analysis to aid decisions regarding therapeutic efficacy
- Edit and/or write sections of protocols and reports as directed by study investigator
- Prepare documents for publication by reviewing analyses and interpretations of data to ensure accuracy and alignment with research data. Ensure clarity of expression
- Compile information and draft presentations to provide the most effective arrangement of data (financial, scientific, medical, business, and academic)
- At least five years medical industry experience
10
Experience For Principle Clinical Research Scientist Resume
- Prepare abstracts of professional literature of a technical nature based on reading and comprehension of the material
- Ensure that the data collected reflects the requested information and can be provided in accordance with specified guidelines
- Produce medical illustrations, publication graphics, scientific posters, and slide presentations for national and international meetings
- Present findings of research projects to professional groups
- Thought leader liaison: Provide liaison between CZMI personnel and thought leaders
- Clinical research roadmap: In cooperation with market segment managers, manage clinical research roadmap for at least one product line or business unit to meet identified needs
- Product teams: Represent clinical/customer needs on assigned product development teams
List of Typical Skills For a Clinical Research Scientist Resume
1
Skills For Senior Clinical Research Scientist Resume
- Good presentation skills for both internal and external audiences (investigator meetings as well as departmental meetings
- Demonstrated ability to communicate effectively and confidently with experts and/or opinion leaders in applicable fields
- Strong team collaboration, leadership, communication (written and verbal), presentation, and issue identification and resolution skills
- Exhibit strong scientific presentation skills
- Proficient in Medical Terminology and medical writing skills
2
Skills For Clinical Research Scientist Gastroenterology Resume
- Knowledge of Medical Terminology and basic medical writing skills
- Possess a positive attitude, superior interpersonal skills and comfort level interacting closely with key physicians and external scientists
- Collaborate effectively with various teams - clinical operations, engineering, cross functional team members, as well as external partners
- Demonstrated experience leading in both matrix and line environment to deliver projects, develop clinical plans, and manage change
- Basic computer skills including Microsoft Office proficiency (e.g. Word, PowerPoint, Excel)
- Competent scientific writing skills
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
3
Skills For Principal Clinical Research Scientist Resume
- Entry level medical writing skills and medical terminology
- Entry level knowledge of CRFs, CRF guidelines, study endpoints and skills to support data review
- Entry Level skills in Microsoft Word/Excel/PowerPoint and data review tools
- Knowledge and skills to support program specific data review and trend identification
- Oncology / Hematology Clinical Development experience; 5+ years of Clinical Research Development experience
- Prior industry-related clinical experience
- Technical/operational experience in planning, executing, reporting and publishing clinical studies
- Technical and operational experience in planning, executing, reporting and publishing clinical studies in industry or Academia
4
Skills For Associate / Clinical Research Scientist Resume
- Experience in reviewing, interpreting and presenting scientific information outside area of expertise
- Experience writing and revising clinical trial-related forms within the pharmaceutical space
- Strong background in data mining, data analysis, literature review, and medical and/or regulatory writing
- Research experience working on novel Machine Learning applications for use in hospital and home patient care settings
- Big Data experience with high performance computing using Hadoop, cloud infrastructure, or related technology
- Experience developing algorithms and building solutions for CT clinical applications
- Significant clinical research or research monitoring experience that provides the required
5
Skills For Clinical Research Scientist Assistant Resume
- Experience working with delivery devices and Human Factors studies
- Implement and validate machine learning algorithms for clinical applications
- 2+ yrs. experience in medical or technical writing
- Experience collaborating with external scientists
- Able to prioritize competing demands for workload
6
Skills For Acpru Clinical Research Scientist Resume
- Experience in writing study protocols and other technical documents
- Sufficiently assertive to deal with confrontational situations while recognizing the need to communicate in an effective and diplomatic manner
- Experience in developing scientific relationships with physicians and institutions
- Experience designing clinical trials for a pharmaceutical industry
- A demonstrated working knowledge of GCP, ICH guidelines, FDA regulations (21CFR812) and EU (ISO14155) regulations
- Experience conducting research in human subjects
- Build and maintain good working relationships with a diverse array of clients
- Experience including involvement with investigational device exemption (IDE) trials is required
- Knowledge and experience writing clinical protocols and reports is required
7
Skills For Clinical Research Scientist Onc Resume
- Experience with outsourcing to Contract Research Organizations
- Hands-on experience with software development tools and programming languages like MATLAB, C/C++, Python, R, Minitab
- Experience in computer programming (Python)
- Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive
- Experience in CR&D roles/responsibilities or equivalent
- Strong sense of teamwork; ability to lead team activities
- Entry level position with expectation of <2 years experience in CR&D roles/responsibilities or equivalent
- Experience with electronic data bases (EDC, RAVE, JReview etc)
8
Skills For Associate Clinical Research Scientist Resume
- Experience in medical or technical writing
- Pharmaceutical/biotech industry or related Clinical Trials Experience
- Experience in clinical research development or equivalent
- 5+ yrs. experience in oncology clinical development
- Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
- Demonstrated ability to work as part of a team
- Relevant in vitro diagnostics experience
- Knowledge and experience with design controls, GCP, HIPAA, QSR, TITLE 21 CFR
- A strong record of accomplishment in research related to clinical science
9
Skills For Clinical Research Scientist Hematology Resume
- Flexible, good natured, cordial team player
- Excellent communications in multi-disciplinary environment
- Experience in the biotech/pharma industry within clinical operations
- Hands-on experience with genomics and/or proteomics assay development
- Able to operate in a complex organizational environment
- Understands the necessity of a strong partnership with colleagues e.g. Clinical Operations, Regulatory, and Safety
- Strike proper balance between independent work and team interaction; good team player in a cross functional team
10
Skills For Principle Clinical Research Scientist Resume
- Experience pharmaceutical industry or CRO environment in the clinical development process
- Prior clinical research support in Medical Devices or Neuromodulation clinical trials
- Proficient in good laboratory and/or clinical practices
- Clinical trial design experience is highly desirable
- Experience in the conduct and management of clinical studies
- Lymphoma experience highly desired
- Experience in a similar role in the Medical Device or Pharma industry
List of Typical Responsibilities For a Clinical Research Scientist Resume
1
Responsibilities For Senior Clinical Research Scientist Resume
- Leading in appropriate interpretation, dissemination and integration of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, etc.
- Responsible for team’s interface and collaboration with key opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies, societies, associations, etc
- Team player with effective verbal and written communication skills in English language
- Experience managing advisory boards, preparation of advisory committees and managing publication of clinical trials
- Provides training, mentoring and guidance to less experienced Clinical Research Scientists
- Strong scientific background with deep understanding of oncology and the molecular diagnostic area
2
Responsibilities For Clinical Research Scientist Gastroenterology Resume
- Significant clinical research or research monitoring experience
- Prioritize project/study timelines to ensure adequate staffing for data management, drug supply, clinical operations, and drug safety
- Foster strong relationships with external stakeholders to shape and influence relevant policies, etc.
- Some experience in medical writing & the ability to write documents such as protocols, clinical study reports, investigators brochures, patient narratives
- Investigator Initiated experience required
3
Responsibilities For Principal Clinical Research Scientist Resume
- Reviewing and providing input on statistical analysis plan Generate study-level publication plans
- Scheduling and coordinating the Review Committee meetings
- Ensuring study drug supply
- Keeping track of study proposals and related documents
- Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate)
- Write pediatric hematology/oncology protocols (writing, reviewing, amending and cross-functional facilitation as appropriate)
- Participates in the development of other technical contributors by supporting training and providing feedback and guidance
- Assist with review of ongoing summary data including: safety, primary efficacy variables, and laboratory data
- Collaboratively and/or independently seeks funding sources and applies for funding to further the goals of the department’s research
4
Responsibilities For Associate / Clinical Research Scientist Resume
- Provide scientific input and review of protocol data, support in assessing medical monitoring reports, study integrity/conduct and protocol oversight
- Conduct review of ongoing summary data including: safety, primary efficacy variables, and laboratory data
- Develops research proposals for submission to funding agencies and prepares grant applications in order to secure funding for research
- Creates and implements short-and long-term plans for various aspects of the RSEU program of research necessary to assist in achieving research funding
- Contribute to the ongoing scientific review of the clinical trial data during the course of the trial
- Plan and develop assigned compounds and assisting with development of CDPs. Oversee and challenge the adequacy of planning for study implementation
- Provide data analysis for testing and development of behavior theories
5
Responsibilities For Clinical Research Scientist Assistant Resume
- Interact with staff responsible for the design, set-up, execution, analysis and reporting of these studies
- Review incoming data from the study for accuracy and completeness
- Report on ongoing Clinical Affairs portfolios
- The development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product
- The reporting of adverse events as mandated by corporate patient safety
- Consults with investigators, residents, clinicians and clinical fellows regarding research design, measurement issues and statistical analyses
- Maintains knowledge as to developments and trends in applicable treatment landscape including current treatment strategies and new therapeutic developments
6
Responsibilities For Acpru Clinical Research Scientist Resume
- Full understanding GCP and ICH Guidelines
- Fast-paced environment working with interdisciplinary teams
- Comfortable with being personally accountable
- In depth knowledge of GSK company policies relating to study management
- Actively participate in the development of scientific talent in the organization. Provide guidance and coaching to team members
- Called upon to develop solutions utilizing creativity and ingenuity
- Possession of a M.A., M.D., or Ph.D. from an accredited college/university according to the Council for Higher Education Accreditation (CHEA)
- Drives the clinical contribution to annual update of IB liaising with Toxicology, Pharmacology, Safety, Regulatory and Medical & Communication Experts
- Drives and integrates clinical contribution to answering regulatory queries and other submissions related to studies
7
Responsibilities For Clinical Research Scientist Onc Resume
- Responsible for reviewing various proposals from investigators
- Support trial data analysis and reporting (e.g., SAEs)
- Assist Clinical Research and Development in identifying potential investigators and sites for clinical trial
- Ensure that all trial deliverables are met according to timelines, budget, operational procedures and quality standards
- Support clinical outsourcing specifications and day to day operational activities with Contract Research Organization(s) (CROs) and/or other 3rd parties
- Support trial data analysis and reporting (e.g., AEs)
8
Responsibilities For Associate Clinical Research Scientist Resume
- Collaborate with the project physician to direct the planning and implementation of clinical programs to meet corporate and clinical research goals
- Provide clinical research expertise in the guidance and recommendations to Clinical Research Physicians in the management of ongoing projects
- Clinical study reporting
- Knowledge of medical, scientific and clinical research techniques
- Mandarin Chinese with medical terminology is highly desirable
- Under minimal guidance, collect comprehensive pharmacokinetic information for potential drug candidates to be included into the company’s development program and to prepare Pharmacokinetic Evaluations if applicable
- Demonstrated Adaptability – Demonstrates an ability to adapt appropriately to changing conditions – business situations, people and changing priorities; an ability to work constructively under pressure; an ability to respond resourcefully to change and ambiguity and learn from one’s mistakes
- Foster Risk Taking – Create an environment that encourages risk taking; demonstrates ability to take and manage appropriate risks and use them to the organization’s advantage
- Advise, guide, and lead development of new survey instruments
9
Responsibilities For Clinical Research Scientist Hematology Resume
- Author scientific publications and presentations and prepare scientific peer-reviewed manuscripts for journal publication
- Participate in scientific review of manuscripts for scholarly journals, textbooks, or edited book chapters, and/or abstracts for papers and posters submitted for presentation at conferences
- Cite recent research and appropriate readings relevant to health behavior/health informatics research
- Develop, implement and manage various initiatives, including: the development of research agendas for specific topic areas; the development of scientific content and identification of content expert speakers for national meetings; and the development and evaluation of public services
- Develop data sets and an online survey system for the collection of research data, methods modification, metrics and techniques, as well as develop a web site user's guide to include a summary of recommendations
10
Responsibilities For Principle Clinical Research Scientist Resume
- Identify and resolve potential problems
- Interact and collaborate with other scientific staff, practitioners and public health administrators
- Participate in and lead collaborative groups that conduct research in behavioral health, especially those that are trans-divisional, trans-NIH, or trans-institutional (including public-private partnerships) in nature
- Provide consultative input and expertise in research and evaluation
- Serve as team leader for project oversight and evaluation
- Work with supervisor in the development of new assignments, program goals, and objectives
- Facilitate an innovative program of research related to outcomes measurement in cancer care, including quality of life, patient experiences of care, cancer survivorship and care quality
- Writes clinical evaluation plans and reports, study protocols, protocol amendments, informed consents, study reports, risk master lists, and scientific papers for publication by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice
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