Clinical Research Specialist Resume Sample
Johnathan Zulauf
96319 Jettie Landing,
Phoenix,
AZ
+1 (555) 761 1467
Work Experience
Clinical Research Specialist
08/2017
-
PRESENT
Detroit, MI
- Contribute to the development of clinical protocols, informed consent forms, and case report forms
- This is a regionally based position: Mid-Central US
- Design recruitment strategies, recruit potential subjects, determine subject eligibility, and consent subjects according to the IRB/protocol approved methodologies. Develop advertisement and other information materials for recruitment. Perform subject interviews and study‐related nonmedical/behavioral interventions and neuropsychological battery testing assessments
- Determine appointments per protocol. Schedule and/or call subjects for appointments and follow-up visits. Assist in the conduct of study‐related non‐medical/behavioral assessments, perform study interview and testing
- Extract data from source documents and assist students with data entry. Complete case report forms and enter into database. Run database error reports during analysis. Address and resolve queries/errors discovered during analysis
- Record, document and report protocol deviations. Communicate with PI/CO‐I on issues. Maintain updated enrollment log for primary study and sub‐studies. Create agenda for team meetings
- Perform and direct studies and/or project(s). Develop, recommend, modify and implement policies and procedures and/or methods for clinical research. Develop protocol manuals and data collection instruments. Participate in the design of research studies
- Perform clinical research activities including advanced data analysis using statistical software such as SAS, SPSS, and R; data management (collection, entry, verification); data interpretation, and ensures compliance and clinical relevance of data
Senior Clinical Research Specialist
08/2014
-
06/2017
Chicago, IL
- Searches relevant literature, develops conclusions on research findings, writes reports, prepare and deliver presentations of relevant findings and conclusions, and recommends appropriate actions. Conduct library research and contributes to the preparation and writing of research findings for publication of journal articles and grant proposals
- Manages interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history. Obtains tissue and blood samples as necessary and collects information through interviews, questionnaires, test results, and charts
- Perform Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) protocol development and ensure compliance of research operations with protocols
- Serves as liaison to other departments, outside organizations, government agencies, and product representatives to promote effective and efficient operation and use of resources
- Experience with direct support to clinical studies or similar
- Strong networking and Project Management skills
- Able and willing to strictly follow procedures/SOP's, regulations and guidelines
Associate Clinical Research Specialist
01/2009
-
06/2014
Los Angeles, CA
- Perform and direct research studies and/or project(s); design and coordinate program evaluations and research projects for the Maryland Public Behavioral Health System
- Oversee projects, analyze data, and provide consultation regarding evaluation, interpretation, and advanced data analysis. Ensures the compliance and clinical relevance of data
- Develop, recommend, modify, and implement policies and procedures and/or methods for research and program evaluation; develop protocol manuals and data collection instruments and training materials
- Perform data collection, data entry, data verification, data analysis, and data validation
- Conduct library research and contributes to the preparation and writing of research findings for publication of journal articles and grant proposals
- Participate in the design of program evaluations or research studies and ensure compliance of research operations with protocols
- Perform and direct studies and/or project(s). Develop, recommend, modify and implement policies and procedures and/or methods for clinical research
- Develop protocol manuals and data collection instruments
Education
DePaul University
2004 - 2008
Bachelor's Degree in Relevant Technical
Professional Skills
- Strong prioritization, organizational, and problem-solving skills
- Strong written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology and technical writing
- Three to five years’ nursing/clinical experience. Prior experience with management of research studies and statistical analysis
- Apply computer skills and effectively use PC office software
- + Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
- + Excellent problem solving skills
- + Ability to manage multiple tasks, good prioritization and organizational skills
How to write Clinical Research Specialist Resume
Clinical Research Specialist role is responsible for interpersonal, medical, terminology, technical, clinical, software, research, design, english, editing.
To write great resume for clinical research specialist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Research Specialist Resume
The section contact information is important in your clinical research specialist 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 Specialist Resume
The section work experience is an essential part of your clinical research specialist 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 specialist 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 specialist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Research Specialist resume experience can include:
- Strong verbal and written communication skills, technical and problem solving skill
- + Strong problem solving influencing skills
- Strong problem solving & influencing skills
- + Ability to multi task to effectively deal with competing business priorities
- Multi task & to effectively deal with competing business priorities
- Multi task & effectively deal with competing business priorities
Education on a Clinical Research Specialist Resume
Make sure to make education a priority on your clinical research specialist 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 specialist 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 Specialist Resume
When listing skills on your clinical research specialist 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 specialist skills:
- Strong proofreading, editing and reviewing skills are essential
- Good problem-solving skills and strategic thinking
- Good writing skills, budget process, and clinical study and data management process
- Demonstrated ability to work effectively on cross-functional and international teams
- Experience directly supporting clinical research or relevant experience in medical/scientific area
- Experience directly supporting clinical research or relevant experience
List of Typical Experience For a Clinical Research Specialist Resume
1
Experience For Senior Clinical Research Specialist Resume
- + Strong judgment interpersonal skills
- + Strong oral and written communication skills in local language and in English
- + Demonstrated ability to work effectively on cross-functional teams
- + Project management and scientific writing skills
- Experience with Good Clinical Practice (GCP), regulatory and/or compliance guidelines for clinical trials
- Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for conducting clinical studies
- CEC charter development and effective execution including training of CEC members
2
Experience For Principal Clinical Research Specialist Resume
- Previous experience working in medical device clinical research or early research roles in either an industry or academic/research group setting
- OR PharmD, PhD, DVM, or MD with 3+ years experience supporting clinical research
- Experience in working in cross functional environment, with Research and Development, Regulatory, International and Legal organizations
- Project Management experience in a clinical setting
- + Develop/review Study Synopsis. This is an executive summary of the proposed study based on the evidence strategy and regulatory assessment
- Experience in a clinical/regulatory role
- Medical Device experience is ideal
- Prepares all central lab kits in a timely manner prior to patient arrival
- OR MS, MA, or MPH with 5+ years experience
3
Experience For Associate Clinical Research Specialist Resume
- Experience in clinical research
- Local evidence dissemination awareness:
- + Provide clinical evidence dissemination to external stakeholders
- + In depth knowledge of local evidence needs and local law regulations
- + General knowledge of ‘Good Clinical Practice’ and applicable regulations
- + Proven to be decisive
4
Experience For Country Clinical Research Specialist Resume
- + Demonstrated ability to work in a matrix organization
- + Strong business savviness
- + 5 years relevant experience in the clinical field
- Experience in applicable regulations including Federal Code of Regulations
- Experience in medical device clinical trials/clinical trial setting
- Experience interacting with healthcare professionals, business management, and patients
5
Experience For Clinical Research Specialist Advanced Resume
- Experience in the healthcare industry (i.e. medical device, biotech, pharmaceutical)
- Experience in healthcare industry (e.g., medical device, biotechnology, pharmaceutical, life sciences,)
- Experience in medical devices
- Clinical experience needed, device or pharma
- Industry experience in clinical trials and biospecimen supervision
- Work independently, multi-task, and prioritize
- MS, MA, or MPH with 3+ years research experience
- PharmD, PhD, DVM, or MD with 2+ years research experience
6
Experience For Prin Clinical Research Specialist Resume
- Maintains the central lab supplies such as - monitoring for expired kits, keeping supplies organized, and monitoring incoming supplies
- Meet Global Safety Reporting Requirements including Periodic Safety Reports
- Communicates with sites on a regular basis, sending updates on current status of study enrollment and follow-up, and assisting with resolution of problems
- Ensure general logistical support for meetings, such as document preparation and taking meeting minutes
- + Coordinates with investigators the ERP submission , tracking, and local administration all in alignment with existing SOP’s
7
Experience For Clinical Research Specialist Son Resume
- Development of Safety Management Plans and be responsible for its training and execution
- Lead Safety data cleaning of study database
- Contribute to safety data trending and analysis
- Critical thinking and judgement in the application of the SOP’s to daily work scenarios
- Provides support and training for clinical study sites to assure data integrity and protocol compliance
- Assists in preparation of study materials and/or training
- Provides support for development of marketing materials to support product activities
- Assists in preparing study strategy, scope and schedule in order to meet business needs
8
Experience For R&D Clinical Research Specialist Resume
- Partners with cross-functional project teams, e.g. RD, Regulatory Affairs, Marketing and Sales
- Ensures proper handling and send outs of PK and central lab samples by lab
- Maintains vital signs as needed for any Research patient during infusions
- Drives innovation through embracing diversity and change
- Contribute in the preparation of clinical protocols and regulatory submissions including 510(k), PMA, IDE, and others
- Special projects (i.e. short-term studies, RSA training, etc)
- + Conduct site monitoring
- + Willing to travel extensively in the country / region
9
Experience For Pr Clinical Research Specialist Resume
- Proficiency in word processing, spreadsheets applications (e.g., MS Word and Excel)
- Identifies inconsistencies in documentation and reporting of adverse events
- Serves as a liaison with Patient Access and Central Scheduling for all issues related to research subjects
- Participate in development of detailed training plans and materials; interface / train investigators, site staff, and CRO staff as applicable
- Maintain IRB submissions, protocol amendments, reportable new information reports, and renewals on multiple clinical trials at a time
- Process blood or other bodily fluid specimens, clinical procedures such as (but not limited to): basic spirometry, 6 Minute Walk Tests (6MWT), aerosol drug delivery, induced sputums procedures for study
- Contribute to CIP (Clinical Investigational Plan) ICF (Informed Consent Form), eCRF (Case Report Form), and CSR (Clinical Study Report) development
10
Experience For RN Clinical Research Specialist Resume
- Perform sponsor assessments of safety events and timely Potential Complaint triage
- Contribute to Clinical Study Reports, Annual Progress Report’s
- Contribute to DSMB activities and other cross functional clinical safety deliverables
- Perform clinical research activities including data analysis; data management (collection, entry, verification); data interpretation, and ensures compliance and clinical relevance of data
- Perform and direct studies and/or project(s). Develop, recommend, modify and implement policies and procedures and/or methods for clinical research and evaluation. Develop protocol manuals and data collection instruments. Participate in the design of evaluation and research studies
- Prepare written reports and presentations of research and evaluation findings for sponsors and other stakeholders
- Ensure that evaluation activities are carried out according to proposed methods and timeline. Prepare reports of deliverable activities to be reviewed by sponsors
List of Typical Skills For a Clinical Research Specialist Resume
1
Skills For Senior Clinical Research Specialist Resume
- Strong judgment & interpersonal skills
- Strong oral and written communication skills in local language and in English
- Excellent decision making/analysis skills
- Good written and oral communications skills, with proficient knowledge of medical terminology
- Demonstrated ability to identify and adapt to shifting priorities and competing demands, and maintain composure in challenging circumstances
- Experience directly supporting clinical research or similar experience in a medical/scientific area
- Experience directly supporting clinical research or experience in medical/scientific area
2
Skills For Principal Clinical Research Specialist Resume
- Experience working with Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials
- Experience directly supporting clinical research or relevant experience in medical/scientific area
- Strong clinical research experience
- Strong knowledge of World Health Organization (WHO) Good Clinical Practice (GCP) and International Conference of Harmonization (ICH)
- Prior experience with electronic medical record and/or clinical trial management software applications
- Computer skills required/ Understanding of MS Suite (Excel, Access and Word)
- SpecializedKnowledge or Skills Required
3
Skills For Associate Clinical Research Specialist Resume
- Experience in cardiovascular medical device development and/or pharmaceutical industry experience
- Work independently on multiple tasks and manage time effectively
- Relevant experience in the clinical field or previous experience in medical device sales/marketing figure
- Successful cross functional team interaction and influencing skills
- Able to work effectively, independently and on cross-functional teams
- Able to write reports, business correspondence and procedure manuals effectively
- Experience project or study management experience in clinical or clinical research/studies/operations
4
Skills For Country Clinical Research Specialist Resume
- Technical and operational experience in planning, executing, reporting and publishing clinical studies in industry
- Hands-on experience in GCP, research conduct, documentation, audit/monitoring, and direct dealings with the FDA
- Knowledge of applicable regulations governing clinical studies and Good Clinical Practice guidelines
- Experience working with vendors/CRO’s
- Experience conducting clinical trials with medical devices and/or pharmaceutical’s
5
Skills For Clinical Research Specialist Advanced Resume
- Experience in medical writing
- Experience directly supporting medical device clinical research
- + Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials
- Experience working in the area of clinical or laboratory research
- Some experience working in the area of clinical or laboratory research
- Experience with Clinical Research conduct and administration
6
Skills For Prin Clinical Research Specialist Resume
- Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines. (20%)
- Project and general budget experience desired
- Expert knowledge of clinical research, EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003, Good Clinical Practice(GCP)
- Clinical research experience with Bachelors or 2+Years with Masters or 1+ with Doctorate
- Experience in a research or hospital environment
- Current Good Clinical Practices (GCP) certification
- STRONG WRITTEN AND VERBAL COMMUNICATIONS ARE ESSENTIAL
- Clinical research experience
7
Skills For Clinical Research Specialist Son Resume
- Experience with a Master’s, with at least 5 years in Clinical Affairs
- Develope and operate the local SOP of clinical research study aligned to global SOP
- Experience in clinical research design
- Experience in Project management and database systems (e.g., MS Project, Access, CTMS, SAP, Agile)
- Experience in clinical or clinical research/studies/operations
8
Skills For R&D Clinical Research Specialist Resume
- Leading the clinical core team in coordinating study activities, such as collecting, reconciling, and reporting clinical data for the study
- Working knowledge of Microsoft Office Suite, including Word, Excel and Powerpoint
- Managing the study strategy (Investigational Plan), budget, resources, and timelines for assigned clinical trial(s)
- Understanding of biostatistics and trial design
- Willing to travel extensively in the country / region
- Working knowledge of clinical research study design and execution
- Coordinate and run research team meetings including developing agendas and taking and reporting out minutes
- Ensures quality by maintaining compliance, reviewing device complaints, reviewing audit reports, and implementing corrective actions
9
Skills For Pr Clinical Research Specialist Resume
- Coordinates with all CRC’s to schedule research patient testing and procedures, including research encounter forms and creating FINs
- Performs data review, generating queries and reports; generating data discrepancies and reviewing completed discrepancy documents
- Assist with data coding, working closely with statisticians for data clean up and preparation for statistical analysis
- Become the study expert and be accountable for driving execution and oversight of all study related activities, including
- Actively participate in the study protocol writing and final report writing process
- Attend study team meeting, take minutes and follow up on action items. Assist CTL in meeting preparation
10
Skills For RN Clinical Research Specialist Resume
- Oversee set-up and maintenance of accurate study budgeting, status tracking and product accountability
- Manage in preparation of study materials and/or training (e.g., training of investigators and site staff)
- Reviews cross-functional marketing collateral for accuracy and messaging
- Maintain clinical study patient files, clinical site notebooks and general investigator notebooks according to standard operating procedures
- Provide ad hoc support on developing presentations, reports and periodic updates regarding study status
- Ensures appropriate oversight of clinical study by internal and external resources including, but not limited to monitoring, staff, CROs, and core laboratories
- Contribute in the development and completion of regulatory reporting requirements, internal reporting requirements, and clinical publications and presentations
- Participate in clinical site audit activities including pre-inspection training at clinical sites and within the department
List of Typical Responsibilities For a Clinical Research Specialist Resume
1
Responsibilities For Senior Clinical Research Specialist Resume
- Adhere to the protocols’ Data Safety Monitoring Plans; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates
- This role requires independent, critical thinking, writing, and editing skills for scientifically complex documents for substantial intellectual content
- Project management and scientific writing skills
- + Works effectively on cross-functional teams
- Experience working on global clinical trials
- Above working experience in clinical trial for drug or devices
2
Responsibilities For Principal Clinical Research Specialist Resume
- Experience in a team setting desirable
- Experience in clinical trials policy and other applicable research billing rules
- Experience working in an administrative / business office of a university, hospital, or research institute
- Designs, plans, and implements clinical studies consistent with global clinical evidence strategy
- + Ensures awareness of local clinical activity and new clinical evidence and provides input to sales marketing leaders
- + If needed, provide clinical evidence for supporting tenders
3
Responsibilities For Associate Clinical Research Specialist Resume
- Clinical research experience (2+ Years with a Masters or 1+ Years with a Doctorate)
- Healthcare Experience - Required
- Relevant experience in the clinical field
- Experience in clinical research (GCPs and regulatory compliance guidelines for clinical trials)
- Prioritize the work of multiple projects
- Medical/scientific experience (e.g. has written and implemented protocols for experiments or animal research)
- Provide high quality clinical evidence to support new device applications or publications
4
Responsibilities For Country Clinical Research Specialist Resume
- Demonstrated ability to manage multiple complex projects simultaneously
- General knowledge of ‘Good Clinical Practice’ and applicable regulations
- Experience in healthcare compliance
- Experience with Federal regulations related to clinical research
- Consenting and reviewing study protocols with study participants
- + Assist in preparation of study materials and/or training Interface with, and assure training of investigators, site staff, and Medtronic clinical staff
- + Identify Medtronic Clinical Trial Management System (CTMS) roles and responsibilities for the study team and train according to the training plan
- Provide significant input and oversight for clinical program safety trending and medical device reporting
5
Responsibilities For Clinical Research Specialist Advanced Resume
- Prepare and assist in preparing annual reports and quality trending reports
- Preparation, review, submission, and tracking of IRB documents
- Assist in soliciting industry-sponsored trials through contacts and professional organizations
- Participate in the evaluation of the protocol, study design, and risk to subject population. Assist in determination of staff availability and assessment of study population/availability
- Participate in the preparation and negotiation of study budget. Determine facility/equipment availability. Participate in critical evaluation and make comment on contracts/agreements
- Provide/create source documentation tools for subject’s charts/records. Develop and implement teaching tools for subjects and families
- Participate in the evaluation of the protocol, study design and risk to subject population. Access and extract information for protocol development for medical library and online databases
6
Responsibilities For Prin Clinical Research Specialist Resume
- + Develop training plan on all procedures, clinical study documents, tools, etc. as required by SOPs
- + In the case of site suspension or early termination, ensure that the operating procedures as outlined in SOPs are followed
- + Ensure study sites are compensated according to agreement
- Partners with cross-functional project teams, e.g. R&D, Regulatory Affairs, Marketing and Sales
- Travel up to 25% of the time (including extended air travel)
- Establish and maintain system for tracking changes in documents submitted to agencies or partners
- Assist in the development of research projects, including the preparation of study documents for the IRB application, SOPs and Informed Consent
7
Responsibilities For Clinical Research Specialist Son Resume
- Computer proficiency required, including data entry into standardized electronic databases
- Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers)
- Maintain enrollment log to keep accurate records to report recruitment statistics to PI and the IRB for continuing renewals
- Participate in conference calls with collaborators at outside institutions regarding material revisions and standard procedures for the study
- Assist collaborators and statisticians in understanding data discrepancies
- Assist PI with abstract, poster, and manuscript preparations, submissions and report writing
- Create and maintain filing systems and study logs for study
- Ensure all study personnel maintain required training requirements
- 3) Investigator-Initiated Trial Monitoring Reviews (IITMRs) and
8
Responsibilities For R&D Clinical Research Specialist Resume
- Local travel required for monitoring of affiliate/satellite sites
- Assist in manuscript preparation
- Preparing patient case studies detailing the patient’s medical history, current disease staging and consequences of research treatment both side effects and disease response
- Models excellence in nursing practice using scientific knowledge and advanced concepts in the assessment, diagnosis, planning, implementation and evaluation of actual or potential problems in the oncology patient population
- Proactively identifies opportunities and investigates solutions to assure the provision of state-of-the-art nursing care and associated outcomes
9
Responsibilities For Pr Clinical Research Specialist Resume
- Influences patient outcomes through the translation, implementation and integration of EBP into daily operational activities
- Collaborates and consults with nurses and other to influence nursing practices and improve care outcomes within a specific unit or service and/or across Nursing and Patient Care Services (NPCS)
- A key stake holder and decision maker for the development, implementation and evaluation of standards of care, policies, guidelines and the introduction of new equipment and technology at the point of care
- Supports nurses in the management of symptom distress related to cancer and/or its treatment based on advanced knowledge of the etiology of cancer, the rationale for treatment, patient and family responses and needs, and associated nursing interventions
- Provides expertise in the assessment of patient and family learning needs, provision of educational strategies and evaluation of the effects of teaching strategies for general and specified oncology patient populations
10
Responsibilities For RN Clinical Research Specialist Resume
- Assumes accountability for unit based, department wide or Institutional clinical practice roles including but not limited to the Ethics Consultation Service, Adult Medical Response Call coverage, and others
- Extract data from source documents. Complete Case Report Forms (CRF) or database entries. Audit for accuracy and correct CRFs. Resolve sponsor queries. Provide/create source documentation tools for subjects’ charts/records
- Effectively leverages resources and time to drive completion of projects
- Validates that written informed consent was appropriately obtained before each subject’s participation in the trial
- Measures and tracks the results of audits performed through action plan follow-up procedures and tracking the impact of any identified revenue enhancement / cost savings
- Maintain and manage study equipment, including troubleshooting/monitoring of subjects’ study computers
- Conduct and manage four interventional study arms and or conduct study-related behavioral assessments
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