NewSenior Clinical Research Coordinator Mass General BrighamSenior Clinical Research CoordinatorBoston, Massachusettsspin/separate/freeze) of all required correlative research blood samples with the coordination of the processing labs for MGH and BWH· Obtain vital signs and perform EKGs as required for individual studies· Administer quality of life assessments as required for individual studies· Scans in research documents and certifies these documents as copiesSkills/Abilities/Competencies Required:· High level time management and organization skills· Excellent written and verbal communication skills· Knowledge of current and developing clinical research trends· Sound interpersonal skills and the ability to mentor others· Ability to work independently and display initiative· Ability to identify problems and develop solutionsEducation:· BA/BS degree requiredExperience:· 2-4 years related experience. Supervisory Responsibilities:· NoneWorking Conditions· Duties will primarily be performed in an ambulatory/clinical office setting· Duties will be performed on-site at both BWH and MGH locations as needed, with support at BWH increasing as our clinical research operations increase at that location.
Clinical Research Coordinator CareerscapeClinical Research CoordinatorBoston, MA$50,000–$65,000 / yearTemporaryThe Clinical Research Coordinator will manage the day-to-day operational requirements of assigned studies, including patient enrollment, protocol adherence, data collection, and regulatory documentation. The position requires direct interaction with study participants, sponsor representatives, and institutional review boards, and demands a working knowledge of FDA regulations and Good Clinical Practice guidelines.
NewClinical Research Coordinator II Mass General BrighamClinical Research Coordinator IIBoston, Massachusetts$24.28–$39.43 / hourspin/separate/freeze) of all required correlative research blood samples with the coordination of the processing labs for MGH and BWH· Obtain vital signs and perform EKGs as required for individual studies· Administer quality of life assessments as required for individual studies· Scans in research documents and certifies these documents as copiesSkills/Abilities/Competencies Required:· Careful attention to detail· Good organizational skills· Ability to follow directions· Good communication skills· Computer literacy· Working knowledge of clinical research protocols· Ability to demonstrate respect and professionalism for subjects’ rights and individual needsEducation:· BA/BS degree requiredExperience:· Minimum of 1-2 years of related experience Supervisory Responsibilities:· NoneWorking Conditions· Duties will primarily be performed in an ambulatory/clinical office setting· Duties will be performed on-site at both BWH and MGH locations as needed, with support at BWH increasing as our clinical research operations increase at that location. The following job duties will be performed under general supervision by the Clinical Research Manager:· Assist clinical team in screening potential patients for study participation· Schedule all protocol required tests and procedures· Coordinate patient appointments with physicians, nurses, and all test areas· Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providers· Prepare pre-visit communication for providers to ensure required assessments are completed and documented· Maintain point of contact communication with enrolled patients and assist with front line questions regarding study participation· Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition· Coordinate, obtain, process, and ship protocol required tissue samples· Ensure collection and processing (e.g.
Senior Clinical Trial Manager eGenesisSenior Clinical Trial ManagerCambridge, MA$142,800–$176,400 / year7+ years work experience in life sciences or medically related field, including 4+ years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company. Assist in preparation and review of clinical study documentation including, but not limited to, protocol, informed consent, study plans, lab manuals, Case Report Forms, Clinical Study Reports, and other study level documents.
Lead Clinical Data Manager Integrated Resources, IncLead Clinical Data ManagerLexington, MassachusettsContractorTakes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve Contributes to regular budget forecasting and regular cost accrual processes and proactively communicates to the team budgetary impacts of decisions or processes implemented to achieve results Courage to challenge. · Partnering with customers as a trusted consultant and becoming an integral part of customer's decision making Supports each clinical study and project team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines.
Clinical Research Coordinator Alcanza Clinical ResearchClinical Research CoordinatorRoslindale, MassachusettsScheduling subjects for study visits and conducts appointment reminders; Building/updating source as needed; Conducting monitoring visits and resolves issues as needed in a timely manner; Ensuring study related reports and patient results are reviewed by investigator in a timely manner; Filing SAE/Deviation reports to Sponsor and IRB as needed; Documenting and reporting adverse events; Reporting non-compliance to appropriate staff in timely manner; Maintaining positive and effective communication with clients and team members; Always practicing ALCOAC principles with all documentation; May assist with study recruitment, patient enrollment, and tracking as needed; Maintaining confidentiality of patients, customers and company information, and; Performing all other duties as requested or assigned. Responsibilities may include but are not limited to: Screening of patients for study enrollment; Patient consents; Patient follow-up visits; Documenting in source clinic charts; Entering data in EDC and answers queries; Obtaining vital signs and ECGs; May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Requesting and tracking medical record requests; Updating and maintaining logs, chart filings; Maintaining & ordering study specific supplies;].
Senior Clinical Trial Manager TScan TherapeuticsSenior Clinical Trial ManagerWaltham, MA$170,000–$187,000 / yearThe submission of unsolicited resumes by recruitment or staffing agencies to TScan Therapeutics or its employees is strictly prohibited unless contacted directly by TScan Therapeutics’ internal Talent Acquisition team. Our state-of-the-art offices with over 70,000 square feet of premium lab space, including an internal GMP manufacturing suite, are an environment that supports innovation, camaraderie, and professionalism.
Clinical Site Relationship Manager Integrated Resources, IncClinical Site Relationship ManagerCambridge, MassachusettsContractorAssures ongoing site compliance with the protocols, informed consent process and documentation, as well as applicable FDA regulations and/or ICH GCP Guidelines and other local regulations critically reviews and analyzes site activities and study conduct through on-site and remote assessments/contacts. Responsible for development of study monitoring and management documentation and tools as delegated by the sponsor, including: Clinical Monitoring Plan, SIV slides, Regulatory Binder, Study Reference Guide, site tools, etc.
Clinical Office Coordinator Adams ClinicalClinical Office CoordinatorWatertown, Massachusetts$22–$25.10 / hourServe as a primary point of contact for site communications, including front desk management, managing the main office phone line, triaging and routing voicemails, and internal updates to administrative and research teams. Demonstrate a strong sense of urgency in maintaining the safety of staff and participants by recognizing and responding appropriately to behavioral or safety concerns as the first point of contact, using de-escalation techniques in alignment with site protocols as needed.
Sr. Clinical Research Program Manager Interstitial Lung Disease Brigham and Women's HospitalSr. Clinical Research Program Manager Interstitial Lung DiseaseBoston, MA$78,936–$128,928.80 / yearThe framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. ILD program RAs and research fellows are adequately documenting and completing their assigned work); development and implementation of patient recruitment/retention strategies and goals; and organization and completion of IRB and regulatory documents.
Senior Clinical Research Director SanofiSenior Clinical Research DirectorCambridge, MA$236,250–$393,750 / yearCollaborates with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. Collaborate with other CRDs within the project, ensure leadership, buildsconsensus, coordinate action plans with stakeholders to resolve project-related study issues, anticipate potential issues (sharing lessons learned) across the project or study teams.
Sr. Clinical Research Associate Getinge GroupSr. Clinical Research AssociateBoston, MAWith a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The Senior Clinical Research Associate will report to the VP Scientific and Medical Affairs and will play an important role in study data management and overall clinical operations of the prospective randomized studies.
Manager, Pre‑Clinical & Clinical Compliance Johnson & JohnsonManager, Pre‑Clinical & Clinical ComplianceRaynham, MA$102,000–$177,100 / yearIn the role as Clinical and Pre-Clinical QA Compliance Manager, GCP Quality activities include GCP Clinical and GLP Preclinical audits will include the following: Preparation prior to the audit, connecting with the clinical research team identified and providing advanced notice including securing availability to conduct the audit. For the DePuy Synthes organization, the Clinical and Pre-Clinical QA Compliance Manager main job responsibilities include conducting internal and external GCP Clinical Quality Assurance (QA) audits which include system, program and clinical site investigator sites as well as GLP Preclinical Quality Assurance Supplier Audits.
Director, Clinical Data Management Stoke Therapeutics, Inc.Director, Clinical Data ManagementBedford, MA$225,000–$244,000 / yearRequired Skills & Experience: Bachelor's degree or higher in a scientific or healthcare discipline (advanced degree a plus), with 10+ years of progressive experience in data management within biotech, pharmaceutical, or CRO settings, including prior line-management / people leadership experience. In depth knowledge of clinical data management systems (eg: Medidata Rave Veeva Vault CDMS) required; working familiarity with data review, visualization, and analytics tools (e.g., SAS, R/Python, Spotfire, Power BI, J-Review, or elluminate).
Lead Clinical Data Manager Katalyst Healthcares & Life SciencesLead Clinical Data ManagerCambridge, MACollaborate with cross-functional teams including Biostatistics, Clinical Operations, Safety, and Regulatory to ensure alignment of data management strategies with overall clinical development goals. Develop and implement data management plans, case report forms (CRFs), edit checks, and data validation plans in alignment with study protocols and regulatory requirements.
Clinical Study Design Manager Science 37Clinical Study Design ManagerBoston, MAThe following qualifications are preferred and/or equivalent applicable experience: Required: 3+ years of experience in clinical research or life science industry, including at least 3 years in design of CRF/ePRO or other clinical trials database capture software. The Clinical Study Design Manager is responsible for working with our clients and internal staff to define the eSource platform specification design for the study, including all data capture requirements, bridging the gap between protocol requirements and implementation.
Lead Clinical Data Manager. Integrated Resources, IncLead Clinical Data Manager.Lexington, MassachusettsFull timeBuilding Authentic Relationships: Building trusting relationships that will enhance current and future needs Leads in developing trust through transparency in communication and individual actions; ensures outcomes are team driven rather than individually driven; promotes collaborative team and organizational success Key Skills, Abilities, and. Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve Contributes to regular budget forecasting and regular cost accrual processes and proactively communicates to the team budgetary impacts of decisions or processes implemented to achieve results.
Clinical Research Associate Alira HealthClinical Research AssociateFramingham, MassachusettsCRAs work closely with the In-house CRAs, Lead CRAs, Director of Clinical Monitoring and Project Managers to ensure sites’ protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
Sr. Clinical Research Program Manager Interstitial Lung Disease Mass General BrighamSr. Clinical Research Program Manager Interstitial Lung DiseaseBoston, MassachusettsThe framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. ILD program RAs and research fellows are adequately documenting and completing their assigned work); development and implementation of patient recruitment/retention strategies and goals; and organization and completion of IRB and regulatory documents.
Clinical Project Manager Integrated Resources, IncClinical Project ManagerLexington, MassachusettsContractorJob Position: Clinical Project Manager Location: Lexington, MA Duration: 6 Months+ (Temp to Perm) Summary: The Clinical Project Manager is responsible for independently managing a small number of studies of basic to moderate complexity or defined activities in more complex, multicenter studies (e.g., managing niche vendors). Our methods include applying domain expertise in specific industry segments, utilizing a highly-skilled workforce, leveraging a proven global delivery model, implementing structured and scalable quality processes and methodologies and yet, staying cost-effective.