Parexel

Clinical Research

• Conduct qualification visits, site initiation visits, monitoring visits, and termination visits at assigned clinical sites
• Generate visit and contact reports
• Build and maintain site relationships as the primary site contact
• Address and resolve site issues and questions
• Oversee study integrity and site delivery from identification through close-out
• Review trial performance and safeguard human-subject rights and well-being in accordance with the protocol
• Develop patient recruitment strategies with clinical sites to meet enrollment timelines
• Ensure compliance with SOPs, protocols and amendments, GCP, and applicable regulatory requirements
• Evaluate reported-data quality and integrity, site efficacy, and drug accountability
• Monitor completeness and quality of regulatory documentation
• Perform site document verification

Clinical Research Associate – Senior, Bilingual French/English

• Assist the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies
• Support adjudication, medical monitoring, imaging data reconciliation, preparation of meeting materials, and protocol deviation management
• Support a single study or multiple studies
• Lead a study with limited scope, such as Survival Follow-up
• Interact with internal and external stakeholders, including study sites and committees, in support of clinical study objectives
• Complete required training curriculum
• Complete timesheets accurately and on time
• Submit expense reports as required
• Update CV as required
• Maintain working knowledge of and comply with Parexel processes, ICH-GCPs, and other applicable requirements

Clinical Scientist – FSP

• Manage clinical sites from identification through closeout
• Serve as the primary point of contact for assigned clinical site teams
• Conduct qualification visits, site initiation visits, monitoring visits, and termination visits
• Prepare timely visit and contact reports
• Manage site quality and delivery throughout the study lifecycle
• Address site questions and resolve issues to support study execution
• Oversee study integrity and build relationships with investigators and site staff
• Review trial performance and safeguard participant rights, safety, and well-being
• Develop patient recruitment strategies with clinical sites to support enrollment timelines
• Ensure compliance with SOPs, study protocols and amendments, Good Clinical Practice, and regulatory requirements
• Evaluate reported data quality and integrity, site performance, and investigational product accountability
• Monitor regulatory documentation completeness and quality
• Perform site document verification
• Conduct onsite monitoring activities and support enrollment and study delivery

Clinical Research Associate – CRA II/Senior

• Assist the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies
• Support adjudication activities
• Support medical monitoring
• Prepare for imaging data reconciliation
• Prepare meeting materials
• Manage protocol deviations
• Support a single study or multiple studies
• Lead studies with limited scope, such as Survival Follow-up
• Liaise with cross-functional lines
• Interact with internal and external stakeholders, including study sites and committees, in support of clinical study objectives
• Complete required training, timesheets, and expense reports
• Update CV as required
• Comply with Parexel processes, ICH-GCPs, and other applicable requirements

Clinical Scientist – Oncology

• Assist the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies
• Support adjudication, medical monitoring, imaging data reconciliation, meeting-material preparation, and protocol deviation management
• Support a single study or multiple studies
• Lead a limited-scope study, such as Survival Follow-up
• Liaise with cross-functional lines
• Interact with internal and external stakeholders, including study sites and committees, to support clinical study objectives
• Complete required training curriculum
• Complete timesheets accurately
• Submit expense reports
• Update CV as required
• Maintain knowledge of and comply with Parexel processes, ICH-GCPs, and applicable requirements

Research Coordinator

• Contribute within the specific Therapeutic Area (TA) and interact with a continuum of stakeholders
• Ensure meaningful and collaborative scientific exchange through engagement activities to globally impact strategies
• Manage the operations of the client’s Investigator Studies Program
• Manage Congress Operations activity for the TA
• Provide congress support for the TA
• Contribute to the development and refinement of the TA Scientific and Medical Affairs Strategic Plan for Our Company Research Laboratories
• Ensure oversight of activities to globally impact the scientific strategy for the TA

Scientific Leadership Research Coordinator

General

• Act as a custodian and leader of the Parexel Quality System and serve as an ambassador for quality across the business and with customers
• Support the development, implementation, and management of Parexel strategic objectives
• Establish and maintain a communication framework that removes constraints and supports timely, effective action on quality matters
• Collaborate with functional leads to design, re-engineer, implement, and adopt the quality framework for validation and release of interfaces and solutions
• Lead activities to identify low- and medium-risk or value improvements for process architecture, including Standard Operating Procedures, manuals, and related quality system documentation
• Support the development, implementation, continuous improvement, training, and adoption of infrastructure, change control, and problem management processes
• Provide guidance, consultation, and quality expertise to project teams supporting clinical trial and validation activities across the applicable lifecycle
• Support oversight and monitoring of compliance status and activities for projects, business areas, or portfolios, including validation planning, resource estimates, risk and impact assessments, summary reporting, and Electronic Records/Electronic Signature regulations
• Assist with risk mitigation by identifying, categorizing, and defining risks and associated mitigation plans
• Support internal customers with technology-related Quality Issue management, including issue descriptions, classification, root cause analysis oversight, and consultation on corrective and preventive actions

Systems Validation Specialist II

Strategy

• Partner with Enterprise Accounts, Growth Accounts, and Strategic Business Units to identify, qualify, and prioritize Oncology opportunities
• Craft creative solutions for sales campaigns and strategic opportunity pursuits
• Advise Sponsors and internal teams using Oncology expertise to develop competitive solution models
• Create customer-focused proposal content differentiating Parexel from competitors
• Ensure client responses reflect strategy discussions, meet client needs, and convey the value proposition
• Define bid pursuit content and integrate considerations into request for proposal strategies
• Support or participate in bid pursuit meetings
• Provide strategic and technical leadership in pre- and post-sales activities and consultancy
• Support clients through the pre-award process and promote solution adoption
• Maintain knowledge of relevant products, pipelines, industry trends, and global regulatory changes
• Bring market requirements and client feedback into Product Management and solution development
• Participate in discovery sessions, solve complex business issues, and present solutions to clients
• Support Strategic Business Unit-specific targets

Integrated Solution Strategy Director – Oncology

• Assist the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies
• Support adjudication activities
• Support medical monitoring
• Prepare imaging data reconciliation
• Prepare meeting materials
• Manage protocol deviations
• Support a single study or multiple studies
• Lead studies with limited scope, such as Survival Follow-up
• Liaise with cross-functional lines
• Interact with internal and external stakeholders, including study sites and committees, in support of clinical study objectives
• Complete required training curriculum
• Complete timesheets accurately
• Submit expense reports
• Update CV as required
• Maintain working knowledge of and comply with Parexel processes, ICH-GCPs, and other applicable requirements

• Manage investigator site relationships and assigned clinical trial site activities from site activation through database lock and close-out
• Ensure clinical trials comply with the Study Monitoring Plan, applicable laws, Good Clinical Practices (GCP), and Sponsor standards
• Serve as primary point of contact for assigned investigator sites and coordinate with the Site Care Partner and study team
• Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure
• Provide site personnel coaching, training, protocol training, and recruitment support
• Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
• Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, clinical supply management, study progress, and metrics
• Identify and resolve site issues, develop corrective and preventive actions, and resolve data queries
• Ensure oversight of investigational product receipt, handling, accounting, storage, and destruction
• Support database release and undertake unblinded monitor responsibilities when appropriate
• Maintain product, protocol, and therapy-area knowledge and provide clinical guidance to investigators
• Drive Quality Event remediation and support audit observation CAPA development and checks

Senior Clinical Research Associate – FSP

Affiliate Manager

• Initiate and coordinate clinical trial site activation activities and essential document management
• Compile high-quality Investigator Initiation Packages leading to site initiation approval
• Resolve and escalate site issues and coordinate supporting roles to ensure timely site activation
• Prepare, validate, and submit regulatory documents, including IIP, IRB approval forms, and FDA 1572/Attestation Forms
• Support central and local ethics committee packages, submissions, communications, and approvals
• Prepare, handle, and distribute clinical documentation and reports according to scope and SOPs
• Support Shared Investigator Platform activities aligned with Pfizer strategy
• Manage essential documents and updates throughout the study lifecycle, including protocol amendments, FDA 1572/Attestation revisions, and ethics committee annual approvals
• Maintain IRB/Ethics Committee activities and file documents to the Trial Master File
• Conduct periodic quality reviews of study files for accuracy and completeness
• Maintain clinical trial systems tracking site compliance and performance
• Support investigator sites and study teams with site audits and responses
• Maintain communication with study teams and investigator sites and provide country- and site-level updates
• Establish tools and disseminate ethics and site approval updates to stakeholders
• Conduct awareness sessions on client requirements and ongoing documentation compliance
• Identify and resolve investigator site issues and align on corrective and preventative actions
• Act as a Site Activation Partner point of contact or subject matter expert on systems, processes, projects, and global initiatives
• Support mentoring of new hires
• Complete required training, timesheets, expense reports, and CV updates
• Maintain compliance with Parexel processes, ICH-GCP, and applicable requirements

Site Activation Partner – FSP, Contractor

Associate

• Build understanding of the organization’s basic consulting models and methodologies and COA Consulting services
• Develop technical skills defined in the responsibilities
• Under general direction of Project Lead and Technical SMEs, ensure client work is performed and delivered on time and meets quality expectations
• Support qualitative research and consulting projects to meet timelines and quality standards
• Conduct and analyze qualitative interviews and generate meaningful insights
• Apply established consulting methodologies and contribute to client deliverables
• Collaborate with project teams and maintain effective client and stakeholder relationships
• Support project documentation, presentations, and operational activities
• Participate in professional development and continuous improvement initiatives

Associate, Clinical Outcomes Assessment

Supply Chain

• Maintain close working relationships with internal customers and provide professional sourcing advice and assistance at all levels
• Monitor the quality and efficiency of sourcing processes, pricing accuracy, purchase requests, approvals, and purchase orders
• Conduct commodity research, supplier selection and evaluation, and requests for information, quotation, and proposals
• Ensure products and services are obtained at budgeted prices and that ancillary materials and investigational products meet local import and export requirements
• Coordinate the return of rental equipment and medical devices, manage returns and refunds, and liaise with suppliers to obtain credit documentation
• Own and action sourcing help desk tickets, create and execute Statements of Work, and complete on-demand sourcing activities that support study needs
• Analyze data and trends to support predictive bulk purchasing and trigger qualifications of new suppliers with Procurement when required
• Anticipate sourcing challenges, take ownership through resolution, and work with suppliers to identify comparable compliant ancillary supplies
• Obtain required supplier and manufacturer documentation for import and export activities
• Take action on quality issues involving third-party suppliers and manage risk mitigation through resolution
• Assist internal customers with sourcing questions and system challenges and mentor junior team members

Supply and Logistics Coordinator

• Serve as the main client point of contact for investigative sites throughout the study lifecycle
• Manage site start-up activities through activation
• Build and retain investigator site relationships and provide support from site recommendation through study closeout
• Support country and site selection activities by providing local intelligence and collaborating with stakeholders
• Conduct site-level start-up activities, including PTA, activation checklist coordination, ICD finalization, and SIV as applicable
• Coordinate site initiation training and collect or complete required activation documentation and systems
• Ensure site readiness for first subject first visit in partnership with site monitors
• Coordinate resolution of escalated site issues, including vendor, contracts, and payment issues
• Support investigational product and ancillary supply strategies throughout the study lifecycle
• Plan and support site recruitment, enrollment, and investigator responses to recruitment issues
• Maintain regular communications with investigator sites and track recruitment, data entry, performance metrics, and study feedback
• Coordinate country or local registry completion with local RA, CTRO, and SAP stakeholders
• Act as the operational point of contact for site-level questions and escalate issues as appropriate
• Review site monitoring reports and support ICD document revisions and submissions
• Maintain site-level systems and alignment across EDC, Shared Investigator Platform, Site Profile, and other applicable systems
• Review and update Site Management Organization Assessments and continuity or contingency plans
• Manage site practices that differ from client practices and liaise with study management and process owners
• Oversee site deliverables including data cuts, interim analyses, database locks, and investigator signatures
• Follow study oversight plans and implement risk mitigations
• Support decentralized capabilities such as home health, ePRO, and DTP
• Assure quality and consistency of monitoring delivery and drive efficiencies and best practices
• Support positive investigator relationships and escalate training or compliance concerns
• Provide local intelligence and input into site recommendations and performance metrics
• Support local requirements for importation and exportation of investigational products and ancillary supplies

Site Care Partner

Compliance

• Act as intermediary between Regulatory/Labeling and Artwork/Change Management teams to communicate planned artwork changes and implementation timelines
• Record regulatory assessments and link the Change Management System to the Regulatory Tracking System
• Support development and maintenance of regulatory-compliant labeling documents throughout the product lifecycle, including CDS, Global Patient Leaflet, Target Label Profile, EUPI, and USPI
• Distribute and track CDS updates in the Electronic Document Management System and regulatory tracking systems
• Track implementation of labeling updates across regions and countries
• Support Regional and Local Regulatory Leads with Health Authority queries and country-specific labeling differences
• Maintain version control and labeling compliance in company systems
• Create, maintain, and update regulatory labeling procedures and SOPs
• Provide training to internal stakeholders and new joiners on labeling process requirements
• Maintain current knowledge of global labeling regulations and governance standards

Clinical Research Associate – Senior, Bilingual French/English

Clinical Scientist – FSP

Clinical Research Associate – CRA II/Senior

Clinical Scientist – Oncology

Clinical Scientist – FSP

Scientific Leadership Research Coordinator

Systems Validation Specialist II

Integrated Solution Strategy Director – Oncology

Clinical Scientist – FSP

Senior Clinical Research Associate – FSP

Site Activation Partner – FSP, Contractor

Associate, Clinical Outcomes Assessment

Supply and Logistics Coordinator

Site Care Partner

Senior Regulatory Affairs Associate – Global Labeling Operations