Clinical Trial Specialist Resume Samples

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L Gerlach

Lee

Gerlach

65414 Triston Villages

Detroit

+1 (555) 490 1314

65414 Triston Villages

Detroit

Phone

p +1 (555) 490 1314

Experience Experience

Los Angeles, CA

Clinical Trial Specialist

Los Angeles, CA

Gaylord-Bayer

Los Angeles, CA

Clinical Trial Specialist

Assist in creating and maintaining study-specific laboratory manuals and provide training of clinical site personnel on laboratory procedures and manuals
Proactively keep manager informed about work progress and any issues (including conflicting priorities and free capacity)
May perform site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with local CRAs
Coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation
Facilitate delivering clinical and biomarker data on active trials to achieve corporate goals
Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
Work with Clinical Assay Team and analytical laboratories on work order requests and logistics pertaining to specimen deployment

Chicago, IL

Publication & Clinical Trial Specialist

Chicago, IL

Goldner Inc

Chicago, IL

Publication & Clinical Trial Specialist

Expand brand and disease area awareness through national congress mapping and increased study report dissemination
Ensure compliance with ICMJE guidelines for the review and publication of scientific material
In collaboration with medical advisors, develop the publication strategy for key assets in oncology, cardiovascular, virology and immune-mediated inflammatory diseases
Manage publication projects from inception to final publication (abstracts, presentations, manuscripts) in collaboration with investigators, writing agencies and biostatisticians
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)
Good knowledge of at least one Therapeutic Areas (Oncology, Cardiovascular, Immunoscience or Virology)
Engaged, dynamic et results-driven

present

Houston, TX

Senior Clinical Trial Specialist

Houston, TX

Trantow, Kassulke and Haley

present

Houston, TX

Senior Clinical Trial Specialist

present

Independently prepare and negotiate clinical site agreements at a site level, including PREDICT Agreements, Letter of Indemnifications (LOIs), etc
Provides training, as necessary, at investigator meetings and other trial-specific meetings such as site initiation visits and monthly teleconferences
Working knowledge of transplant patient care and apheresis collection a plus
Other duties as assigned
Participate in internal audits/client meetings with support
Prepare and submit IRB/IEC application and follow up until final approval received (initial submission and amendments)
Conduct country specific feasibility and/or site pre-qualification

Education Education

Bachelor’s Degree in Proficiency

Brigham Young University

Bachelor’s Degree in Proficiency

Skills Skills

Client focused approach to work; ability to interact professionally with external customers
 Strong ability to influence and negotiate resolutions and outcomes with sites
Ability to interact professionally with external customers
 Ability to interact professionally with external customers
Good computer skills including but not limited to the knowledge of a Clinical Trial Management Systems, MS-Office products such as Excel, Word
Client focused approach to work with the ability to interact professionally within a client organization
Strong ability to influence and negotiate resolutions and outcomes with sites
Proficient in written and oral English and fluent in relevant local language
Ability to work across cultures
Ability to work independently with little oversight and to proactively seek guidance when necessary

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15 Clinical Trial Specialist resume templates

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Clinical Trial Specialist Resume Examples & Samples

Provide biospecimen management for company sponsored clinical trials in oncology
Under direction of the Director, Clinical Operations the Clinical Trial Specialist works with the clinical teams to help plan/design and execute biospecimen handling logistics
Assist in creating and maintaining study-specific laboratory manuals and provide training of clinical site personnel on laboratory procedures and manuals
Engage with preferred vendors associated with sample collection kits and execution of associated logistics including quality oversight and rapid reconciliation of biospecimens
Work with Clinical Assay Team and analytical laboratories on work order requests and logistics pertaining to specimen deployment
Facilitate delivering clinical and biomarker data on active trials to achieve corporate goals
Develop, maintain and manage appropriate study documentation
Collect, review and approve regulatory documents from clinical sites
Maintain and reconcile Trial Master File
Provide logistical support for study team with the maintaining of tracking systems and tools, managing preparation of necessary materials and being responsible for recording and distributing minutes
Manages clinical operations site payment system, prepares site invoices and supporting documentation and initiates/creates clinical/regulatory department Purchase Orders
Bachelor's degree in science or health-related field required
3+ years laboratory research experience and proven ability to train laboratory personnel; background in immunology or oncology strongly preferred
Direct experience in biospecimen management required
Prior clinical trial support from the clinical site side or pharmaceutical/biotechnology R&D environment from the sponsor side is a plus
Candidate is a team-player who is detail-oriented; can successfully multi-task, supporting several projects simultaneously; knows how to identify/recognize issues and propose solutions with moderate guidance
Prior experience in start-ups and/or life sciences
Advanced-level skill with Excel, Word, PowerPoint, Outlook and forms creation
Strong organizational and time management skills; ability to work independently
Command of oral and written English business communications
Excellent interpersonal communication and customer service skills

Clinical Trial Specialist Resume Examples & Samples

Manages Site Essential Documents review during study start-up, maintenance and close-out period
Prepares study documents (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)
Ensures tracking of essential documents are received and filed in the CTMS, reviews site documents for accuracy; provides clinical team support with CTMS filing and management
Ensures tracking of patient status throughout the study at investigative sites
May review and approve trip reports, track data query reports, site visit metrics, and overall site performance
May perform routine monitoring at limited clinical sites
May perform site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with local CRAs
Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
May assist in the preparation of, and may present at investigator vendor meetings and workshops
Actively involved in the performance of study feasibility assessments
Adheres to study timelines, quality, and budget for assigned studies
Provides rapid action to address both internal and site QA findings from audits
Coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation
Routinely participates in department and clinical trial team meetings and participate in collaborative efforts (e.g. protocol development, CRO selection, departmental initiatives, etc.)

Senior Clinical Trial Specialist Resume Examples & Samples

Organise ICF translations per study/regulatory/client requirements if required
Customise, review, configure, and negotiate as required country/site specific Informed Consent Forms (ICF) and their amendments
Complete routine departmental administrative tasks in an accurate and timely manner (e.g. timesheets, metrics, etc.)
Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner- Manage sites and protocols across multiple therapeutic areas independently
Support less experienced staff on project assignments as appropriate
Participate in internal audits/client meetings with support
Ability to work across cultures
Strong ability to influence and negotiate resolutions and outcomes with sites

Clinical Trial Specialist Resume Examples & Samples

Prepare and collect high quality feasibility site documents
Conduct feasibility site contacts
Customise, review, configure, and negotiate as required country/site specific feasibility documents
Prepare and submit feasibilities to the relevant research bodies within the UK and Ireland
Ensure good understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely, and efficient delivery
Maintain a positive, results orientated work environment, building partnerships and modelling teamwork, communicating to the team in an open, balanced, and objective manner
Manage sites and protocols across multiple therapeutic areas independently
Ability to interact professionally with external customers
Flexible attitude with respect to work assignments and new learning· Attention to detail
Willingness to work in a matrix and virtual team environment and to value the importance of teamwork
Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word
Effective time management in order to meet daily metrics, team objectives, and department goals
Ability to work independently with little oversight and to proactively seek guidance when necessary
Previous experience in feasibility activities for UK and Irish clinical trials or equivalent experience in clinical research with understanding of clinical trials methodology and terminology

Senior Clinical Trial Specialist Resume Examples & Samples

Conduct country specific feasibility and/or site pre-qualification
Resolve CSA changes requested by the site and approve any change in CSA language with support from Site Contract Leader (SCL) as required
Ensure excellent understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely, and efficient delivery
Substantial monitoring experience in clinical research/Clinical Research Organizations
Educated to degree level (biological science, pharmacy or other health related discipline)
Strong working knowledge of EDC systems and IVRS
Solid understanding of therapeutic indications and study protocol
Ability to lead a "virtual" team
Competent in written and oral English and Ukrainian and Russian

Clinical Trial Specialist Resume Examples & Samples

Review and validate site identification list
Collect and negotiate Confidentially Agreements (CDA) as required
Organize translations per country/regulatory/client requirements
Review and approve country specific and/or site specific documents or essential regulatory documents (SRP)
Customize, review, configure, and negotiate as required country/site specific Informed Consent Forms (ICF) and their amendments
Prepare and negotiate as required initial and/or amended CSA at a site level
Collect internal CSA signatures
Proactively keep manager informed about work progress and any issues (including conflicting priorities and free capacity)
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXELSOPs, other PAREXEL training requirements, and study specific procedures and training
Update all appropriate Clinical Trial Management systems (CTMS) as indicated per function on an ongoing basis and submit all relevant documents to central files per the Central File Maintenance Plan
Escalate any site and study issues that require immediate action to the Functional Lead (FL)
Proactively work with other project teammembers to meet project goals
Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner
Manage complex sites and protocols across multiple therapeutic areas with a high level of autonomy
Provide input to country selection strategy
Anticipate impact of issues/delays/changes on study timelines and communicate to FL
Participate in internal audits/client meetings with minimal supervision
Proactively inform manager about work progress and any issues to avoid unforeseen situations and recommend solutions
Require minimal supervision by Manager
Act as functional/technical Subject Matter Expert (SME) as required
Identify inconsistencies and inefficiencies in processes/systems/trainings and recommend solutions
Participate in internal and external process improvement initiatives
Substantial previous clinical trial start-up experience or equivalent experience in clinical research with strong understanding of clinical trials methodology and terminology
Fluent English, Lithuanian and Russian

Clinical Trial Specialist Resume Examples & Samples

Prepare andnegotiate as required initial and/or amended CSA at a site level
Maintain a good working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL training requirements, and study specific procedures and training
Proactively work with team members to meet project goals
Previous experience in start-up activities for clinical trials or equivalent experience in clinical research with understanding of clinical trials methodology and terminology

Clinical Trial Specialist Resume Examples & Samples

Strong computer and internet skills
Strong knowledge of regulatory requirements including GCP and local laws
Ability to successfully work in a “virtual” team environment
Ability to effectively prioritize multiple tasks and consistently achieve project timelines
Effective problem solving skills
Client focused approach to work with the ability to interact professionally within a client organization
Self-motivator, able to take initiative and work independently
Flexibility towards work assignments, new learning and travel as required by the project (may include overnight, weekend and occasional international travel)
Strong negotiation and diplomacy skills
Native Dutch, or very high level of Dutch

Senior Clinical Trial Specialist Resume Examples & Samples

Substantial previous clinical trial start-up experience or equivalent experience in clinical research
Strong understanding of clinical trials methodology and terminology
Previous experience from international CRO
Experience in working homebased
Fluent in English and Swedish

Clinical Trial Specialist, CPS Resume Examples & Samples

Provide support to study team as applicable
Responsible for completeness, quality, tracking, and accessibility of Central Files
Responsible for accuracy of coded documents/naming conventions for central files
Provide Clinical Lead and the team with detailed information on study procedures and study related materials
Ensure adherence to Good Clinical Practice, applicable regulatory and legal
Excellent interpersonal, verbal and written communication and customer service skills
Ability to communicate directly with study team members in an international environment
Ability to communicate directly with Sponsor / other vendors
A flexible attitude with respect to work assignments, new learning and travel
Demonstrated ability to manage multiple and varied tasks with positive attitude, prioritize workload with attention to detail and within agreed timescales
Demonstrated ability to work independently and use initiative to complete tasks
IT literate – Experience with Microsoft based applications and general knowledge of PC functions, especially knowledge of Excel
Competent in oral and written English and the local language
Previous involvement as CRA assistant in an international study or similar experience in office management of international trial or other related experience would be preferred

Clinical Trial Specialist Resume Examples & Samples

Significant clinical trials experience ideally in Study Start Up
Educated to degree level (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience
Good computer skills including but not limited to the knowledge of a Clinical Trial Management Systems, MS-Office products such as Excel, Word
Sound awareness of all relevant regulations, including GCP

Senior Clinical Trial Specialist Resume Examples & Samples

Proficiently conduct and as project situations warrant, lead country specific feasibility and/or site pre-qualification and/or site selection activities
Proficient in adapting, collecting, reviewing and approving country specific and/or site specific documents, such as Informed Consent Form (ICF) or essential regulatory (SRP) documents with high quality
Prepare and submit IRB/EC application until final approval received (initial submission /Amendments)
Independently prepare and negotiate clinical site agreements at a site level, including PREDICT Agreements, Letter of Indemnifications (LOIs), etc
Ability to identify trends and issues and implement action plan with Functional Lead and/or Management
Act as an independent Country Coordinator on simple, moderate and complex projects in a non-client facing role. Define key study start-up deliverables as well as frequency and content of study tracking updates together with PL/COL/SUL support CTSs with prioritization and organization. Collect, track and report SSU metrics, as assigned
Ability to guide team members towards project milestones
Ability to make appropriate decisions in ambiguous situations
Enlists the support of team members in meeting goals
Carefully weighs the priority of project tasks and directs team accordingly
Strong negotiation, diplomacy and team leadership skills
Ability to take initiative, work independently and delegate
Ability to adapt to varying work styles in accordance to the strengths and development areas of SSU team members
Effective time management in order to meet daily metrics or team objectives
Dutch fluency required
Competent in written and oral English
Extensive clinical, regulatory or clinical site agreement experience in Clinical Research required

Clinical Trial Specialist Resume Examples & Samples

Maintain a good working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXELSOPs, other PAREXEL training requirements, and study specific procedures and training
Advanced ability to manage multiple and varied tasks with enthusiasm
Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS- Office products such as Excel and Word
Advanced problem solving skills
Willing and able to travel locally and internationally occasionally as required
Proficient in written and oral English and fluent in relevant local language

Clinical Trial Specialist Resume Examples & Samples

 Good presentation skills
 Client focused approach to work
 Ability to interact professionally with external customers
 Flexible attitude with respect to work assignments and new learning
 Advanced ability to manage multiple and varied tasks with enthusiasm
 Attention to detail
 Willingness to work in a matrix and virtual team environment and to value the importance of teamwork
 Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word
 Strong interpersonal, verbal, and written communication skills
 Advanced problem solving skills
 Sense of urgency in completing assigned tasks
 Effective time management in order to meet daily metrics, team objectives, and department goals
 Ability to work across cultures
 Ability to work independently with little oversight and to proactively seek guidance when necessary
 Strong ability to influence and negotiate resolutions and outcomes with sites
 Willing and able to travel locally and internationally occasionally as required
 Proficient in written and oral English and fluent in relevant local language
 Previous experience in start-up activities for clinical trials or equivalent experience in clinical research with understanding of clinical trials methodology and terminology

Publication & Clinical Trial Specialist Resume Examples & Samples

In collaboration with medical advisors, develop the publication strategy for key assets in oncology, cardiovascular, virology and immune-mediated inflammatory diseases
Manage publication projects from inception to final publication (abstracts, presentations, manuscripts) in collaboration with investigators, writing agencies and biostatisticians
Expand brand and disease area awareness through national congress mapping and increased study report dissemination
Ensure compliance with ICMJE guidelines for the review and publication of scientific material
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)
Pharm.D./Ph.D. or M.D. degree in life science area
Two (2) years of experience in editing, translating and publishing medical information
Good knowledge of at least one Therapeutic Areas (Oncology, Cardiovascular, Immunoscience or Virology)
Excellent project management skills, planning and organizational skills
Good understanding of the pharmaceutical industry
Strong verbal and written communication skills in English and French
Team work skills, ability to get results through others
Engaged, dynamic et results-driven

Senior Clinical Trial Specialist Resume Examples & Samples

Work out clinical evaluation protocol with hospital expert
Monitor clinical evaluation to be realized as plan and in compliance
Communicate with CFDA and hospital on clinical requirements
Work with registration staff on registration plan
Collect and file clinical data and result analysis
Involve in RA team other works

Senior Clinical Trial Specialist Resume Examples & Samples

Ability to work in a matrix and virtual team environment and to value the importance of teamwork
Strong computer skills including but not limited to the knowledge of Clinical Trial Management Systems (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word
Excellent time management in order to meet daily metrics, team objectives and department goals
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred),nursing or other relevant qualification/experience
Excellent written and oral English and fluent in relevant local language

Clinical Trial Specialist Resume Examples & Samples

Demonstrates ability to successfully lead, mentor, and train CTSs
Provides feedback on CTS performance regarding department goals and objectives
Proficient at CTS duties with minimal oversight
Contributes
Bachelor's degree or relevant work experience in clinical research/health related industry required
Strong Microsoft Office skills (Outlook, Word, and Excel) required. Aptitude in learning new computer systems required
Ability to be flexible and multitask required
Basic medical terminology or knowledge desired
UBC-CE1

Clinical Trial Specialist Resume Examples & Samples

Contributes to the development of solutions to complex issues, analyze current policies and procedures, and recommend changes as needed
Demonstrates understanding and application of UBC systems and work environment
Generate and review project specific metrics as needed

Clinical Trial Specialist Resume Examples & Samples

Manage
Train sites on their continued
Provide site training and guidance in
Confirm sites are compliant with subject
Track study activities, milestones,
Generate and review project specific

Clinical Trial Specialist Resume Examples & Samples

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; 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; ensure protocol deviations are reported to IRB as appropriate; conduct remote monitoring visits and complete site reports; ensure sites meet contractually required enrollment obligations
Facilitate payment distribution of investigator sites through the evaluation of contractual milestone achievements
Demonstrate ability to successfully lead, mentor and train CTSs; provide feedback on performance regarding department goals and objectives; proficient at CTS duties with minimal oversight; 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. Demonstrate complete understanding and application of UBC systems and work environment and general and review project specific metrics
BA/BS or relevant working experience
0 – 2 years experience with Bachelor degree; 6 – 8 years relevant work experience in clinical research/health related industry preferred
Excellent written and verbal communications skills required. Strong Microsoft Office skills (Outlook, Word, Excel) required. Aptitude in learning new computer systems required
Ability to 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. Flexibility and ability to multitask required. Basic medical terminology or knowledge desired. Ability to 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

Senior Clinical Trial Specialist Resume Examples & Samples

Prepares and/or reviews study-related or essential study start-up documents as they relate to the supported clinical trials as delegated by the study manger (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters)
Works with multiple contract research organizations to communicate detailed timelines and ensure that transferred obligations and performance expectations are met. Provides corrective instruction, as necessary, when performance expectations are not being met
Attends internal team and other meetings as required
Provides training, as necessary, at investigator meetings and other trial-specific meetings such as site initiation visits and monthly teleconferences
Creates and reviews site feasibility assessments required for study participation
Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations
Proactively identifies potential study issues/risks and recommends/implements solutions; ensures issues are escalated as appropriate to Senior Manager
Prepares metrics and updates to key deliverables for management
Prepares site newsletters and other correspondence related to clinical trial conduct (eg, best practices and lessons learned, frequently asked questions) in collaboration with the study team
Assists in resolution of routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol

Senior Clinical Trial Specialist Resume Examples & Samples

Thorough knowledge and application of project specific protocol
Consistently completes on site monitoring in accordance with project specific timelines
Consistently completes travel scheduling in accordance with project specific and UBC guidelines
Attends project team meetings, department meetings and minimum of monthly 1:1 with manager; responsible for content of these meetings
Consistently completes site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs; signs, scans and/or provides to Clinical Site Specialist/Regulatory
Document Specialist for filing in Trial Master File according to UBC and/or sponsor timelines requiring minimal corrections
Ensures follow-up of site issues and action items per UBC/sponsor timelines
Enters site visits, confirmation/follow-up letters and site monitoring reports into UBC’s Clinical Trial Management System
Ensures completion of Call Log or Telephone Contact Report detailing communication with sites per protocol
Monitors within Electronic Data Capture data entry, if applicable, and assists sites with Case Report Form resolution
Completes Regulatory Binder and Investigational Product reconciliation
Maintains regular contact with assigned sites per study requirements
Consistently submits expense reports within UBC timelines; consistently follows UBC Travel Guidelines
Consistently completes SOP review and documentation within requested timelines
Consistently completes sponsor specific training and documentation within requested timelines
Bachelor’s degree – Life Science preferred or equivalent years of industry and monitoring experience
Minimum of > 24 months active monitoring
Thorough knowledge of medical terminology
Consistently meets or exceeds metrics for quality trip reports and letters
Consistently meets or exceeds metrics for completion of UBC and/or sponsor training with appropriate documentation
Ability to perform tasks in UBC’s Clinical Trial Management System, Electronic Data Capture System, Outlook and client specific systems (if applicable)
Thorough knowledge of International Conference on Harmonisaton, Good Clinical Practice guidelines, Code of Federal Regulations and UBC SOPs
Up to 80% travel

Clinical Trial Specialist Resume Examples & Samples

Demonstrate complete understanding and application of UBC systems and work environment and general and review project specific metrics
LI-CE1
0 – 2 years of experience with Bachelor degree: 6 – 8 years relevant work experience in clinical research/health related industry preferred

Clinical Trial Specialist Resume Examples & Samples

Prepare, distribute, collect, evaluate, and approve regulatory documents required for regulatory compliance and IRB submission
Submit regulatory documents to Central IRBs and manage site submissions to Local IRBs; confirm IRB approval is received and documented
Conduct regulatory packet submissions to clients for site approval and drug release
Create and review project planning documents including but not limited to Essential Document Review Plan (EDRP), Site Management Plan, and Project Plan
Track milestones, generate study metrics, and provide written and verbal updates to internal and external customers
Confirm sites have notified IRB of closure and final subject status in compliance with regulations
Confirm sites have returned or destroyed study drug and other study supplies as required
Train sites on their continued contractual, regulatory, and legal obligations
Conduct Site Management Activities
Evaluate sites to determine interest, adequate subject population, facilities, staff and qualifications to conduct a study
Execute confidentiality agreement, contract and budget negotiation with sites
Provide site training and access to required systems, including vendor systems
Provide site training and guidance in reference to protocol compliance
Provide site training and guidance in reference to regulatory requirements and ensure compliance
Manage site relationships to ensure positive interactions through routine site contact
Evaluate site performance and compliance with required FDA regulations, ICH/GCP, and local laws
Confirm sites are compliant with subject rights and privacy requirements
Ensure sites meet subject safety reporting regulations: subject safety information is disseminated appropriately by evaluating consistency, quality and timeliness of serious adverse events reported by the site and submission to the IRB
Manage site inventory of study drug, laboratory supplies, and any other study materials to ensure sites have sufficient inventory to conduct study activities without delay
Escalate potential misconduct , fraud or noncompliance by sites to Project and Functional Management and Quality Assurance
Instruct sites on study or protocol requirements and determine subject qualification based on subject eligibility parameters
Track study activities, milestones, document receipt, and payment status in CTMS
Participate in internal/external project team meetings
Essential Document Management and Audit Readiness
Create Trial Master Files (TMF) and maintain essential documents in compliance with FDA regulations, ICH/GCP, and local laws
Manage ongoing collection and quality review of updated essential documents for submission to the TMF
Preserve document security and integrity
Ensure Regulatory Authority and Client audit readiness of TMF
Prepare, package, and archive TMF at study closure
Perform Remote Monitoring Activities
Verify accurate and timely electronic data entry of study subject information
Review electronic data and ensure protocol deviations are reported to IRB as appropriate
Collaborate with sites to achieve query resolution of electronic data
Manage sites in meeting subject enrollment targets to meet contractual obligations
Conduct remote monitoring visits and complete requisite visit reports
Facilitate Payment Distribution to Investigative Sites
Contribute to project plans outlining payment strategy
Evaluate data to identify milestones ensuring sites are paid according to the contract
Process and distribute investigative site payments

Clinical Trial Specialist Resume Examples & Samples

Conduct and facilitate specific start-up activities such as feasibility, site identification, pre-qualification
Site Regulatory Package (SRP) review and approval
Clinical Site Agreements (CSA) and Informed Consent (ICF) customization and negotiation (where required), and IRB/IEC application preparation and submission, in accordance with relevant regulations, SOPs and study specific procedures
Previous experience in study start up highly preferred
Life science degree
Fluent English and Polish

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