Clinical Trial Specialist Resume Sample
Kim Dibbert
26513 Carlie Street,
Dallas,
TX
+1 (555) 727 2356
Work Experience
Clinical Trial Specialist
08/2016
-
PRESENT
New York, NY
- Enters site visits, confirmation/follow-up letters and site monitoring reports into UBC’s Clinical Trial Management System
- Prepare, distribute, collect, evaluate,
- Instruct sites on study or protocol requirements
- Manage Regulatory and Institutional Review Board (IRB) Activities
- Coordinate and implement regulatory and Institutional Review Board (IRB) activities as required in the management of site clinical trials research involving the collection, documentation and compilation of research data
- Ensure compliance with safety regulations by evaluating the consistency, quality and timeliness of serious adverse event reporting
- Responsible for site management activities to ensure compliance with subject informed consent, right and privacy requirements; in the evaluation of subject population, facilities, staff and qualifications
Senior Clinical Trial Specialist
06/2010
-
03/2016
San Francisco, CA
- Evaluate, guide and train site staff on protocol and regulatory compliance / requirements
- Provide in-house and vendor system training and access
- Execute confidentiality agreement, contract and budget negotiations
- Create, evaluate, manage and preserve Trial Master Files (TMF) and essential documents in compliance with FDA, ICH/GCP regulations and local laws
- Prepare, package and archive SMF/TMF at study closure
- Ensure regulatory authority compliance and client audit readiness of TMF
- Review, verify accurate and timely submission of electronic data entry of study subject information
Clinical Trial Specialist, CPS
08/2003
-
04/2010
Boston, MA
- Ensure protocol deviations are reported to IRB as appropriate
- Conduct remote monitoring visits and complete site reports
- Ensure sites meet contractually required enrollment obligations
- Demonstrate ability to successfully lead, mentor and train CTSs
- Provide feedback on performance regarding department goals and objectives
- Exert influences of objective and long range goals of the organization
- Develops solutions to complex issues, analyze current policies and procedures and recommend changes as needed
- Strong Microsoft Office skills (Outlook, Word, Excel) required
Education
Western Carolina University - Asheville
1998 - 2002
Bachelor's Degree in Nursing
Professional Skills
- Proven communication skills including global communications, communications to senior management, project teams and other project stakeholders
- Strong Microsoft Office skills (Outlook, Word, and Excel) required
- Effectively plan and meet site activations on an ongoing basis
- Experience managing others to higher performance
- Clinical Research Development Experience
- Significant clinical trials experience in Study Start Up
- Provenability to work across cultures
How to write Clinical Trial Specialist Resume
Clinical Trial Specialist role is responsible for planning, organizational, computer, microsoft, clinical, interpersonal, word, excel, finance, training.
To write great resume for clinical trial specialist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Trial Specialist Resume
The section contact information is important in your clinical trial 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 Trial Specialist Resume
The section work experience is an essential part of your clinical trial 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 trial 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 trial specialist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Trial Specialist resume experience can include:
- Demonstrate broad and comprehensive knowledge of theories, concepts, practices and policy with the ability to use them in complex and/or unprecedented situations across multiple functional areas
- Excellent in English, both written and oral communication
- Excellent ability to work independently but seekguidancewhen necessary
- Strong ability to influence and negotiate resolutions and outcomeswith sites
- Experience within the Pharmaceutical/CRO industry
- Experience with Project Management software (MS Project) desirable, but not required
Education on a Clinical Trial Specialist Resume
Make sure to make education a priority on your clinical trial 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 trial 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 Trial Specialist Resume
When listing skills on your clinical trial 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 trial specialist skills:
- Excellent organizational skills and ability to prioritize and multi-task with high level of independence
- Skills set corresponding with preferentially 4+ years’ relevant clinical trial experience or equivalent
- Advancedproblem solving skills
- Experience within the Pharmaceutical/CRO industry or equivalent clinical research site experience
- Demonstrate ability to successfully lead, mentor and train CTSs; provide feedback on performance regarding department goals and objectives
- Experience working in a team across multiple functional areas (e.g., Quality Assurance, Data Management, Medical Affairs, Finance)
List of Typical Experience For a Clinical Trial Specialist Resume
1
Experience For Senior Clinical Trial Specialist Resume
- Meeting Management for various levels of meetings
- Actively involved in organization of team and vendor meetings including preparation of agenda/ minute taking and updating any risk/ issue/ decision logs
- Supports the SM/LTM in collecting and maintaining all documents throughout the trial and post-trial in both vTMF (i.e., IF/LAF sections) and paper files
- Where applicable, provide the training and or the updates on the sample exportation related regulations/process to the dept. and cross functions
- Distributes, collect, review, and track regulatory documents, agreements and training documentation
- Ensure TMF filing and maintenance is done routinely by Clinical Trial Assistant (CTA)
- Reviews data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
- Review and verification of contacted vendor activities including vendor invoice review
- Sense of urgency in completing assignedtasks
2
Experience For Publication & Clinical Trial Specialist Resume
- Flexibility and ability to multitask required
- Lead operational initiatives to meet or exceed customer service standards and expectations in assigned site(s) and/or across multiple areas in a timely and respectful manner
- Evaluate, guide and train site staff on protocol and regulatory compliance / requirements; provide in-house and vendor system training and access; execute confidentiality agreement, contract and budget negotiations
- Prepare, package and archive SMF/TMF at study closure. Ensure regulatory authority compliance and client audit readiness of TMF
- Review, verify accurate and timely submission of electronic data entry of study subject information; ensure protocol deviations are reported to IRB as appropriate
- Conduct remote monitoring visits and complete site reports; ensure sites meet contractually required enrollment obligations
- Flexibility and ability to multitask required. Basic medical terminology or knowledge desired
- Act as Liaise with Finance teams, Legal, HCC, Procurement, C&G, GCO Q&C, and other stakeholders to obtain guidance and escalate issues as appropriate
- Partners with the LTM and Site Manager to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements
3
Experience For Clinical Trial Specialist, CPS Resume
- In liaison with the LTM, ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes
- Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval process
- Supports the LTM or, where applicable the SM, in providing the current and complete documents requested by the IEC/IRB and HA
- Manage multiple high level parallel tasks; work unsupervised, have effective computer skills, possess the ability to apply new techniques, and strong prioritization skills
- Participate in phase III and IV research projects and maintain an updated book of work on ongoing Canadian clinical trials (investigators’ sponsored research trial, outcome research studies and BMS driven studies)
- Develop study specific tracking systems if applicable
4
Experience For Clinical Trial Specialist Resume
- Manage time demands, incomplete information or unexpected events
- Maintain global operational tracking and reporting systems and tools including, but not limited to, the study/project budget and financial management data, YourDOCs (invoices), SAP, RACE, Impact, Rave/EDC, ShareDoc, QDoc, QBox, eTMF/pTMF, MicroStrategy, PharmaCM, Phar, C-Track (contracts), Study drug destruction trackers etc.
- Provide detailed oversight and support for cost tracking (including site budgets, Purchase Order tracking,) for forecasting, study budgets, project budgets and special events
- Create and maintain Payment /Accrual trackers based on fully-executed site budgets for U.S. Sites within global CS. Provide monthly study/site accruals to R&D Controlling and CS Resource & Contract Management.
- Provide monthly payment details to site budget contacts and perform final budget/payment reconciliation and close-out
- Review, track, and reconcile invoices via YourDOCs based on knowledge of the protocol, review of EDC data/eCRF’s, patient visit design, lab draw timings and other study specific parameters that require understanding of the therapeutic area specifics and study conduct
- Provide operational support for site selection and CDA process by liaising globally with internal and external partners to facilitate progress and identify potential issues
5
Experience For Senior Clinical Trial Specialist Resume
- Assist and collaborate in development of project/study related documents and templates (feasibility, ICF’s contact cards, eTMF/TMF Plan, study/site contact lists, drug safety, IvRS) and support Clinical Study Report preparation (e.g. appendices)
- Collaborate with Study Manager to review eTMF/TMF and site payments section of RFP to confirm oversight, filing responsibility, and resource allocation for country, study, and site level documents
- Tracking and maintaining study status updates internally and externally
- Provide in-house and vendor system training and access; execute confidentiality agreement, contract and budget negotiations
- Ensure protocol deviations are reported to IRB as appropriate; conduct remote monitoring visits and complete site reports
- Assist with oversight of study metrics and present/report issues, progress, and status at global meetings via written and verbal communication
- Coordinate project/study material preparation and global study communication internally and with vendors including but not limited to trial insurance, regulatory greenlight, study tracking tools and reports, current SOP’s, safety communication, mass correspondence, and shipment of study supplies
6
Experience For Publication & Clinical Trial Specialist Resume
- ) Provide detailed support for cost tracking (study budgets, project budgets and special events. Exercise clear decision making on invoice reconciliations based on knowledge of the protocol, patient visit design, lab draw timings and other study specific parameters that require understanding of the therapeutic area specifics and study conduct
- ) Provide technical and administrative support and expertise for contract tracking by acting as a main point of contact for contract handling and by liaising globally with internal and external partners to facilitate progress and identify potential issues
- ) Assist with oversight of study metrics, compliance with systems use and present/report issues, progress, and status at global meetings via written and verbal communication (if applicable)
- Actively involved in organization of team meetings including preparation of agenda/ minute taking and updating any risk/ issue/ decision logs
- Maintain global operational tracking and reporting systems and
7
Experience For Clinical Trial Specialist, CPS Resume
- ) Assist and collaborate in development of project / study related documents. Support Clinical Study Report preparation (e.g. appendices) if applicable
- ) Coordinate project / study material preparation and global study communication internally and/or with vendors
- Prepares study documents and manuals (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)
- Support the study and/or program team(s) in the successful execution of assigned clinical trials and programs, in compliance with international GCP guidelines/regulations and Standard Operating Procedures (SOPs)
- Partner with the Clinical Operations Lead (COL) and Study Management Team (SMT) members and/or the Director, Clinical Operations Science (DCOS) and Clinical Development Team (CDT)
- Own the development and ongoing maintenance of key operational plans and tools to ensure that on-time completion, accuracy, and quality standards are maintained through the course of the program and/or study
- Assumes relevant tasks, based on experience and training, in support of program and/or study delivery
- Ensure the initial population and maintenance of internal systems and tools is accurate, complete and provides a clear understanding of why any changes occur
8
Experience For Clinical Trial Specialist Resume
- Follows established procedures and SOPs, seeks ways to improve and streamline
- Ensures tracking of essential documents are received and filed in the TMF, reviews site documents for accuracy; provides clinical team support with TMF filing and management
- Assist with oversight of study metrics, compliance with systems use and present/report issues, progress, and status at global meetings via written and verbal communication (if applicable)
- Assist and collaborate in development of project / study related documents. Support Clinical Study Report preparation (e.g. appendices) if applicable
- Coordinate project / study material preparation and global study communication internally and/or with vendors
- Manage Master Department and Program Charts
- Manager Department Web Page
9
Experience For Senior Clinical Trial Specialist Resume
- Tools, Infrastructure Development and Analysis
- Prepare for and Support Global Development Goals Review Meetings
- Other tasks as assigned by Client management
- Prepares study documents and manuals (i.e. consent forms, site instructions, study specific material such as the Manual of Operations, Pharmacy binder, etc.)
- Review and approve trip reports, track data query reports, site visit metrics, and overall site performance
- Be able to work cross-functional with
- Provides oversite of CRO and vendor activities
- Maintains policy and protocol for providing clinical trial information to IRC contacts and conducts clinical trials searches for patients, their caregivers and health professionals according to established protocols
- Keeps current on listings and status of clinical trial programs for blood-related cancers such as the FDA, NCI and pharmaceutical listings
10
Experience For Publication & Clinical Trial Specialist Resume
- Reactively and proactively educates patients, caregivers and health professionals on clinical trials, the questions to ask physicians about clinical trials, assists IRC contacts in developing the decision-making tools to make informed choices about clinical trial options
- Occasional travel to national oncology/hematology meetings
- Proficiency in Microsoft Office (e.g., Word, Excel, and Outlook)
- Familiarity with the global regulatory authorities (FDA, SFDA, PMDA, MOH EMA, etc.)
- Perform activities in a timely and accurate manner
- Previous strong experience in start-up activities for clinical trials or equivalent experience in clinical research with understanding of clinical trials methodology and terminology
- Substantial previous clinical trial study start-up experience or equivalent experience in clinical research with strong understanding of clinical trials methodology and terminology
- Previous experience in start-upactivities for clinical trials or equivalent experience in clinical researchwith understanding of clinical trials methodology and terminology
- 2 – 4 years of experience in clinical research/pharma/biotech Ability to successfully prioritize and work on multiple tasks Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
List of Typical Skills For a Clinical Trial Specialist Resume
1
Skills For Senior Clinical Trial Specialist Resume
- Previous EC submission experience working in CRO or pharma industry
- Excellent ability to work independently but seek guidance when necessary
- Excellent ability to influence and negotiate resolutions and outcomes with sites and IRBs/IECs
- Proven ability to work across cultures
- Proficient in English language. Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint)
2
Skills For Publication & Clinical Trial Specialist Resume
- Substantial clinical, regulatory or clinical site agreement experience in Clinical Research required
- Willing and able to travellocally and internationally occasionally as required
- Maintain HGRA application, approval and samples exportation related data tracking, as well as the relevant files archiving
- ) Support to functional Heads of ECL&OPLs in presentations, organizing trips, equipment ordering, and other general tasks
- Contribute to the smooth running of the department and departmental activities e.g. arranging meetings and travel
- Follow-up on appropriate site related questions or outstanding documents
- Manage ongoing collection and quality
- Maintain appropriate clinical trials management system (CTMS) as indicated per function on an ongoing basis
3
Skills For Clinical Trial Specialist, CPS Resume
- Organize project meetings and taking of minutes
- Ensure CRF pages are being processed, tracked and forwarded to Data Management on time
- Aptitude in learning new computer systems required
- Competent in written and oral English and Dutch OR French, with a working knowledge of the other language
- Fluency in Dutch is required
- Proficient in written and oral English and fluent in relevant local language (Danish)
- Coordination and Operational Support
4
Skills For Clinical Trial Specialist Resume
- Provide detailed support for cost tracking (study budgets, project budgets and special events. Exercise clear decision making on invoice reconciliations based on knowledge of the protocol, patient visit design, lab draw timings and other study specific parameters that require understanding of the therapeutic area specifics and study conduct
- Provide technical and administrative support and expertise for contract tracking by acting as a main point of contact for contract handling and by liaising globally with internal and external partners to facilitate progress and identify potential issues
- ) Provide proactive, close support to Study Manager with quality control and verification of the TMF managed/maintained by external suppliers
- Proactively negotiate with HGRAC and hospitals to ensure each permit application successful and each batch permit of trial samples to be exported successfully, per the trial plan
- Proactively work with local study teams to collect the data, address the issues and concerns to respond the internal/external environment change, and to proactively provide the inputs on the sample exportation application process optimization and issues resolution, supported by Functional Manager, GCO Q&C and stakeholders
- Adapt, collect, review and approve country specific and/or site specific documents, such as Informed Consent Form (ICF) or essential regulatory documents (SRP) with high quality
- Track milestones, generate study metrics,
- Ensure Regulatory Authority and Client
5
Skills For Senior Clinical Trial Specialist Resume
- ) Provide expertise in non-project activities
- ) Provide technical expertise for the eTMF
- ) Provide consultative guidance on new systems, processes and procedures (e.g. SharePoint, inspection readiness, etc.)
- ) Actively suggest means to increase efficiency and other improvement measures
- ) Provide technical expertise of the Bayer budget and payment systems (YOUR-DoceS, for assistance with forecasts, actual cost updates, etc.)
6
Skills For Publication & Clinical Trial Specialist Resume
- ) Provide expertise with the use of Bayer SOP repository (QDoc and others as necessary)
- Assist with QC/audit of central files, coordinate resolution plan, and liaise with Research Regulatory Compliance (RRC) personnel as required
- Responsible for up to date reports of study status in CTMS or client equivalent
- Support Functional Leads in the set-up and maintenance of systems e.g. PMED
- Proactively flag and escalate any project related issues
- Have up to date knowledge on study procedures and study related materials
7
Skills For Clinical Trial Specialist, CPS Resume
- Serve as a resource for the project team or Clinical team, depending on workload can be delegated to other project related tasks (e.g. set-up activities, other)
- Recommend process improvements for Clinical Research Assistant tasks
- Proactively work with other project teammembers to meet project
- Maintain a positive, results orientated work environment, building partnerships andmodeling teamwork, communicating to the team in an open, balanced, and objective manner
- Recognize out of scope activities and communicate to FL
8
Skills For Clinical Trial Specialist Resume
- Recognize impact of issues/delays/changes on study timelines and communicate to FL
- Successfully work in a (virtual) team environment
- Customize, review, configure, and negotiate country/site specific Informed Consent Forms (ICF) and their amendments
- Strong computer skills including the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS- Office products such as Excel and Word
- Perform tasks in UBC’s Clinical Trial Management System, Electronic Data Capture System, Outlook and client specific systems (if applicable)
9
Skills For Senior Clinical Trial Specialist Resume
- Participate in internal/external project
- Create country specific / site specific (if necessary) Informed Consent Form (ICF)
- Review and approve country specific ICFs (if necessary)
- Prepare and negotiate clinical site agreement at a site leve
- Resolve CSA changes requested by the site and approve any change in CSA language with support from Site Contract Leader (SCL)
10
Skills For Publication & Clinical Trial Specialist Resume
- Interact professionallywith external customers
- Manage multiple high level parallel tasks; work unsupervised, have effective computer skills, possess the ability to apply new techniques, have a working knowledge of all Microsoft Office programs and strong prioritization skills
- Provide detailed support for cost tracking including: study budgets, project budgets and special events
- Flexible attitude with respect towork assignments and new learning
- Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic DocumentManagement System (EDMS), andMS- Office products such as Excel and Word
List of Typical Responsibilities For a Clinical Trial Specialist Resume
1
Responsibilities For Senior Clinical Trial Specialist Resume
- Phase 1 clinical trial experience
- Tracking and Budget
- Maintain global operational tracking, reporting systems and tools
- Comfortable working in systems and applications and learning new technology
- Exposure to drug development in industry (biotech/pharma) setting
2
Responsibilities For Publication & Clinical Trial Specialist Resume
- Independently learn and master new computer systems and technology (e.g. PDP, Visio, videoconferencing facilities )
- Provide technical and administrative support and expertise for contract tracking
- Clear ability to influence and lead in driving change in the organization
- Collaborative problem-solving capabilities as part of a team
- Familiarity with key concepts of project management
- Operate with a high level of independence as well as appropriately identify and solicit guidance High Proficiency in MS office suite (Word, PowerPoint, Excel, Outlook, Project)
3
Responsibilities For Clinical Trial Specialist, CPS Resume
- Demonstrates organizational intelligence – ability to understand and successfully navigate in the Biogen (complex) environment to collaborate with other key functions
- Excellent written and verbal communication skills. Ability to succinctly summarize meetings and conversations in written form and identify key themes, decisions and actions
- Solicit and incorporate feedback in development of draft documents or processes
- Assist with oversight of study metrics, compliance with systems use and present/report issues, progress, and status at global meetings via written and verbal communication
- Support the maintenance and construction of study specific internet based forums, such as study websites, SharePoints, Investigator Portal, etc
- Ensure the quality, completeness, availability and quality of the clinical study documents
4
Responsibilities For Clinical Trial Specialist Resume
- SharePoint Site Creation/Management
- Execute confidentiality agreement,
- E.g., clinical trial management
- Work across cultures
- Work independently with little oversight and to proactivelyseek guidance when necessary
- Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements
5
Responsibilities For Senior Clinical Trial Specialist Resume
- Ensure sites meet subject safety
- Working knowledge of the applicable regulations including FDA Good Clinical Practices, ICH Guidelines, and understanding of other major regulatory agencies Regulations and Guidances
- Knowledge of drug development and clinical trial processes, including related standards and documents
- Liaise with Clinical Science Resource & Contract Management from start-up to close-out including Confidentiality Disclosure Agreement implementation and finalization, prioritizing oversight of study budget and amendment timelines, initiating Purchase Order creation and start-up payments, and completion and routing of monthly site payment details to StM and RCM
- 11 11.) Participate and support audits (Regulatory Authorities and Bayer QA), inspections and verification of TMF. Ensure the quality, completeness, availability and quality of the clinical study documents in the Trial Master File to enable final compilation of the documents for regulatory submissions and approval of new medications and medical devices
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