Clinical Research

• Support the team in enrolling eligible patients on oncology clinical trials
• Work as a CRC at Brigham and Women’s Hospital and assist the Clinical Research Manager with implementing clinical trials across disease specialties
• Schedule all protocol-mandated tests required for institutional and federal research compliance
• Assist management with Standard Operating Procedure changes, compliance processes, training new staff, specialized program studies, and disease-specific administrative tasks
• Screen potential patients for study participation
• Coordinate patient appointments with physicians, nurses, and testing areas
• Schedule clinical safety laboratory specimen draws and ensure timely results
• Prepare pre-visit communications for providers
• Maintain point-of-contact communication with enrolled patients and answer study participation questions
• Develop protocol-specific flow charts, intake sheets, and compliance/data-acquisition tools
• Coordinate, obtain, process, and ship required tissue samples
• Collect and process correlative research blood samples with MGH and BWH processing labs
• Obtain vital signs and perform EKGs as required
• Administer quality-of-life assessments
• Scan and certify research documents as copies

Senior Clinical Research Coordinator

• Contribute to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
• Monitor clinical trial data at study sites to ensure adherence to protocols and GCP guidelines
• Perform data review, reconciliation and standardization to ensure high-quality outputs
• Review clinical data to support assessment of investigational drug safety and efficacy
• Support development of clinical documents, including Clinical Study Protocols, Investigator Brochures, and Clinical Study Reports
• Maintain knowledge of the therapeutic area, disease state, and potential drug effects
• Assess clinical data to identify and analyze safety concerns and adverse events
• Stay current with relevant medical literature and clinical trial methodologies
• Conduct literature reviews for focused scientific questions or documentation
• Collaborate with clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical, and project management teams
• Work closely with the Medical Director, Clinical Development, to execute key tasks

Clinical Scientist, Clinical Development

• Recruit subjects using approved methodologies; evaluate and track participant eligibility
• Enroll participants, explain research procedures, and obtain informed consent
• Schedule study visits and conduct reminder calls, messages, or mailings
• Administer study visits, qualitative interviews, quantitative assessments, and surveys
• Save and review participant data according to study protocols
• Coordinate participant remuneration
• Organize and quality-assure study visit transcripts
• Participate in qualitative coding, qualitative and quantitative analyses, quantitative data cleaning, and generation of manuscript tables and figures
• Abstract patient demographic and clinical data from electronic health records
• Communicate with research managers, Principal Investigators, BMC/BUMC IT, and outside programs/vendors
• Maintain study visit materials, data collection systems, regulatory submissions, and regulatory files
• Coordinate weekly study team meetings, including scheduling, note taking, and action-item follow-up
• Participate in study team quality improvement and education activities
• Conduct background literature reviews
• Supervise and train student research assistants
• Perform office-related duties such as answering phones, handling mail and faxes, and scanning

Clinical Research Coordinator II, Pediatrics

• Implement clinical project plans in accordance with key study documents, corporate objectives, and regulatory objectives
• Facilitate internal project team meetings
• Drive all aspects of study start-up, including CRO selection
• Serve as point of contact for sites, vendors, and CROs
• Monitor CRO and vendor adherence to scope of work
• Manage investigator and investigative site interactions in accordance with regulatory requirements
• Identify, resolve, and escalate issues jeopardizing timely clinical study completion
• Develop and manage clinical trial budgets and facilitate contract review
• Participate in vendor, site, and CRO audits as appropriate
• Participate in site monitoring visits as necessary
• Plan and present at Investigator Meetings, company meetings, and other meetings
• Develop internal tracking and reporting tools for Leadership study-status reporting
• Adhere to department SOPs, GCP/ICH guidelines, and QC/QA procedures
• Travel internationally and domestically up to 20% as required
• Perform other duties and responsibilities as required

Associate Director – Senior Clinical Trial Manager II

• Perform data management tasks from study start-up through database lock for assigned clinical research projects
• Manage paper-based and electronic data capture (EDC) studies
• Ensure overall data quality and documentation on clinical research projects
• Work on mid-to-large complex projects across various indications
• Serve at times as program manager overseeing multiple studies for the same client
• Lead a team of clinical data managers to ensure contracted activities follow Veristat Standard Operating Procedures and/or sponsor-specific requirements
• Promote consistent operations, efficient resource use, knowledge sharing, and best practices with Data Management leadership
• Assist with training data managers on project-specific and general data management processes, procedures, and systems
• Provide training to other company functions as needed

Principal Clinical Data Manager

• Support the primary data management representative for eClinical Solutions and sponsor data management interactions
• Ensure eClinical Solutions data management processes are followed and deliverables meet quality and timeline requirements within approved scope
• Provide study requirements including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, and Query Management
• Define specifications and collaborate with the technical team on elluminate configuration for data-cleaning strategy and oversight activities
• Perform quality control on study documents, program and report specifications, deliverables, and elluminate modules
• Perform holistic data review and trending analysis through reporting and elluminate analytics to identify issues and risks and develop mitigation strategies
• Monitor and interpret KPIs, metrics, dashboards, and reports for process and efficiency improvement
• Perform other duties as assigned

Clinical Data Manager – Contract

• Ensure successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, academicians, and collaboration partners
• Work in a matrix with the Medical Director and functional representatives to execute activities within scope, compliance, budget, and timelines
• Support establishment and growth of Clinical Development functions and global capabilities
• Facilitate and execute creation, updating, and review of clinical and regulatory documents, including protocols, informed consents, Investigator Brochures, clinical study reports, publications, IND clinical sections, annual reports, safety update reports, charters, management plans, manuals, and SOPs
• Support clinical and scientific aspects of clinical study design, implementation, conduct, analysis, interpretation, and documentation
• Provide clinical and scientific expertise for investigator/site staff and vendor selection
• Train internal colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol
• Provide scientific and medical support throughout clinical trials and respond to questions from sites, IRBs/IECs, Health Authorities, and CROs
• Review, query, and analyze clinical trial data
• Partner with the Medical Director on medical monitoring, patient eligibility, and study treatment-related questions
• Present clinical trial data internally and externally
• Create clinical study and program-related slide decks
• Represent clinical studies or development programs on teams or sub-teams
• Build and maintain KOL/investigator networks; organize and present at KOL advisory boards and investigator meetings; engage advocacy groups
• Conduct or contribute to therapeutic area/indication research and competitor analysis
• Build relationships with internal experts
• Develop, track, execute, and report on goals and objectives
• Ensure compliant business practices

Senior Manager, Clinical Scientist

• Provide statistical support for assigned clinical development programs or trials
• Participate in the development of study protocols
• Develop statistical analysis plans and analysis specifications for programming implementation of statistical analyses
• Provide statistical input into data management and programming deliverables, including data collection tools and analysis datasets
• Develop statistical programs for ad-hoc requests, manuscripts, and presentations
• Provide statistical review of scientific reports and publications
• Collaborate with other functional areas on project deliverables and timelines
• Provide oversight of CRO deliverables to ensure quality and accuracy
• Adhere to company and department SOPs and working practices
• Act in accordance with Company policies, including the Code of Business Conduct and Ethics
• Perform other duties as assigned
• Report to the Director, Biostatistics

Senior Biostatistician

• Plan, drive, and oversee all aspects of multicenter global clinical trials in compliance with GCPs, SOPs, designated budgets, and timelines
• Drive implementation of clinical operational strategy for assigned clinical studies
• Optimize trial design and execution and collaborate with study teams to accelerate clinical trial timelines
• Manage CROs and vendors, including contracting and clinical budgets
• Develop contingency plans for clinical trials
• Coordinate and lead study team meetings and update the Program Team on timelines and milestones
• Contribute to study documentation, including protocol review, study plans, ICFs, and CRF design
• Participate in CRO/vendor identification, qualification, and selection
• Participate in site selection; review consent forms; track patient accrual and study progress; assure patient eligibility; document protocol deviations/violations; and manage adverse event reporting
• Oversee clinical monitoring from site qualification through site closure
• Assure clinical data integrity through review of case report forms, source documents, and medical records
• Evaluate and analyze clinical data
• Oversee CRO delivery of studies in alignment with timelines and budgets
• Establish transparent communication, clear goals, and risk-based oversight
• Ensure compliance with internal policies, GCPs, and applicable regulations; maintain inspection readiness
• Oversee vendor contracts and clinical study budgets; report progress to Finance
• Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing
• Oversee TMF management and review TMF documentation
• Travel to field sites as needed, under 25%

Senior Clinical Trial Manager

• Support day-to-day activities within one or more clinical trials, including country/site feasibility assessments, site selection, start-up, maintenance, and close-out.
• Serve as a key operational point of contact for CROs and trial sites, identifying and escalating potential issues as needed.
• Assist with oversight of CRO and vendor set-up and ensure timely study initiation.
• Review site-level regulatory documents and escalate issues to appropriate stakeholders.
• Help ensure inspection readiness, TMF quality, and adherence to protocol and regulatory requirements.
• Identify operational challenges and propose mitigation plans with senior team members.
• Assist with review of protocols, informed consent forms, case report forms, and other clinical study documents.
• Monitor study performance metrics, timelines, deliverables, and CRO trip reports.
• Track study budgets and vendor invoices/change orders and flag discrepancies.
• Maintain study registration and updates on ClinicalTrials.gov and other applicable registries.
• Coordinate Clinical Trial Team meetings and drive action item follow-up.
• Maintain clinical operations trackers, databases, and document repositories.
• Provide study updates to internal stakeholders and support enrollment, database lock, and study closeout activities.