Clinical Research Registered Nurse ( PT WeekDay) Alcanza Clinical Research LLCClinical Research Registered Nurse ( PT WeekDay)Methuen, MARequesting and tracking medical record requests; Updating and maintaining logs, chart filings; Maintaining & ordering study specific supplies; Scheduling 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; o Filing SAE/Deviation reports to Sponsor and IRB as needed; o Documenting and reporting adverse events; o Reporting non-compliance to appropriate staff in timely manner; o Maintaining positive and effective communication with clients and team members; o Always practicing ALCOAC principles with all documentation; Be thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable), and study medication(s) for the assigned research study; Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc. Responsibilities may include but are not limited to: Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP, ICH regulations and guidelines: 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; Performing procedures commensurate with licensure including vitals, ECGs/EKGs, venipunctures, injections, infusions, mixing drug and/or dispense investigational product; etc.
Sr. Manager, Clinical Data Management ModernaTXSr. Manager, Clinical Data ManagementCambridge, MassachusettsRemote7 years of experience must include: Vendor Management; Medidata RAVE, InForm, and Oracle Clinical EDC tools; Clinical Data Management using Biomarker and External data; Utilizing eTMF tools; Study Database Lock processes including Final, Interim, Snapshots, DSUR submission, and Staggered Lock; Study Initiation, CSR Review, and SAE Reporting; J-Review, I-Review, and Clinbrowser; and. Lead the creation and maintenance of study cross functional data review plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plans, coding guidelines, Serious Adverse Events (SAE) reconciliation guidelines, and database lock plans.
Per Diem Clinical Research Nurse - Home Visits Science 37Per Diem Clinical Research Nurse - Home VisitsManchester, NH$50–$55 / hourWith interest/expertise in Science 37's decentralized model of care delivery, the Mobile Research Nurse will perform delivery of care to participants as well as collaborate with brick and mortar sites, if indicated, for shared clinical trial implementation. Science 37's Nursing Solutions Group brings together expert nurses who share a passion for organizing, planning and implementing mobile clinical nurse services to participants in clinical trials.
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.
Clinical Research Director, Rare Diseases SanofiClinical Research Director, Rare DiseasesCambridge, MA$206,250–$343,750 / yearExperience / Skills: MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization. On Clinical Development, the CRD: Designs the global clinical development strategy (in close cooperation with other members of the team, particularly Regulatory Affairs end Health Economics) and leads the clinical development with regard to ongoing development activities and planned LCM for labelling changes.
Clinical Research Director - Rare Diseases SanofiClinical Research Director - Rare DiseasesCambridge, MA$178,500–$257,833.33 / yearExperience / Skills: MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization. On Clinical Development, the CRD: Designs the global clinical development strategy (in close cooperation with other members of the team, particularly Regulatory Affairs end Health Economics) and leads the clinical development with regard to ongoing development activities and planned LCM for labelling changes.
Principal Scientist, Clinical Research - Immunology/Dermatology Merck & Co IncPrincipal Scientist, Clinical Research - Immunology/DermatologyBoston, MA$255,800–$402,700 / yearAssist the Senior Director, Associate Vice-President/Vice-President and Product Development Team Lead in ensuring that appropriate corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.
Clinical Research Coordinator I Brigham and Women's HospitalClinical Research Coordinator IBoston, MA$20.16–$29.01 / hourFollowing established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc. and maintaining and updating data generated by the study. Conduct monthly study visits with participants; this includes completing surveys and data forms, measuring vital signs, collecting blood and urine samples, and providing 10 minutes of behavioral support for quitting smoking or quitting vaping.
Senior Clinical Studies Associate DeephealthSenior Clinical Studies AssociateSomerville, Massachusetts$71,000–$96,000 / yearFull timeWorking under the guidance of Clinical Study Manager and cross-functional study teams, the SCSA contributes to study operations, documentation, regulatory compliance, and process improvement initiatives. This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking.
Senior Manager- Knowledge Management for Clinical Affairs Integrated Resources, IncSenior Manager- Knowledge Management for Clinical AffairsCambridge, MassachusettsContractorJob DescriptionJob Title: Senior Manager – Knowledge Management for Medical AffairsDuration: 14+ MonthsLocation: Cambridge, MAResponsibilities:Gathering end user requirements from key stakeholders and review of technical specifications for information governance in partnership with IT, maintaining of critical functionality of the CRM platform to ensure uninterrupted access by HCPs to company product information;Creation and maintenance of all metrics and analytic tools necessary for supporting GMA decision making and maintenance of the content management system used by Worldwide Medical. Project management expertise with focus on driving for results and sense of urgencyMinimum of 7-10 years clinical data systems experience working in the biotechnology or pharmaceutical industryExperience applying best practices in application development to the clinical trial environment, including requirements definition and QC plansAware of current global regulatory guidelines relevant to Clinical Data Management, as well as related Pharma Development SOPs, guidelines and Best Practices.
Fellow in Human-Machine Interface Clinical Research - Bionics Lab Harvard UniversityFellow in Human-Machine Interface Clinical Research - Bionics LabCambridge, MA$50,000–$70,000 / yearThe Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) Bionics Lab ( https://bioniclab.seas.harvard.edu/ ) is seeking a highly motivated Fellow with a background in Biomedical Engineering, Mechanical Engineering, or Neural Engineering to join our interdisciplinary research team. You will work at the intersection of neuroscience, engineering, and clinical science, gaining hands-on experience with human subject research, robotics, and electrophysiological data analysis, while contributing to impactful translational research.
Clinical Research Assistant Brigham and Women's HospitalClinical Research AssistantBelmont, MA$21.53–$29.08 / hourThe Neurobiology of Fear lab at McLean and Center for Suicide Research and Prevention at MGB/Harvard is seeking applications for 1 full-time Clinical Research Assistant (CRA) to coordinate and administer an NIMH-funded project aimed at using mobile devices to understand, predict, and intervene to prevent suicidal behavior among adults recently hospitalized on a psychiatric inpatient unit. The Ressler Lab in McLean's Depression & Anxiety Division seeks to advance what is known about the brain, behavior, and symptom mechanisms underlying adult mental health conditions, including suicide, non-suicidal self-injury, depression, PTSD, anxiety, and bipolar disorder.
Development Medical Director - Clinical Research Director SanofiDevelopment Medical Director - Clinical Research DirectorCambridge, MA$178,500–$297,500 / yearThe role of the DMD is to: Collaborate with other medical and clinical scientific experts DMDs or Development Scientific Directors (DSDs) in the project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction. Provide appropriate clinical scientific input & support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators.
Lead Clinical Data Manager Katalyst Healthcares & Life SciencesLead Clinical Data ManagerBoston, 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 Research Registered Nurse ( PT WeekDay) Alcanza Clinical ResearchClinical Research Registered Nurse ( PT WeekDay)Methuen, MassachusettsRequesting and tracking medical record requests; Updating and maintaining logs, chart filings; Maintaining & ordering study specific supplies; Scheduling 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; o Filing SAE/Deviation reports to Sponsor and IRB as needed; o Documenting and reporting adverse events; o Reporting non-compliance to appropriate staff in timely manner; o Maintaining positive and effective communication with clients and team members; o Always practicing ALCOAC principles with all documentation; Be thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable), and study medication(s) for the assigned research study; Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc. Responsibilities may include but are not limited to: Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP, ICH regulations and guidelines: 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; Performing procedures commensurate with licensure including vitals, ECGs/EKGs, venipunctures, injections, infusions, mixing drug and/or dispense investigational product; etc.
Clinical Research Coordinator Peregrine TeamClinical Research CoordinatorBoston, MAPeregrine Team is seeking a Clinical Research Coordinator to support clinical trial operations for a leading pharmaceutical organization. Coordinate day-to-day clinical trial activities, including patient scheduling and follow-ups.
Clinical Research Coordinator - Londonderry, NH Dana-Farber Cancer Institute IncClinical Research Coordinator - Londonderry, NHLondonderry, NH$48,100–$54,400 / yearThe Clinical Research Coordinator (CRC) will work within the Dana-Farber Londonderry, NH Satellite clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DFCI disease programs. Responsible for data reporting and management, collection of source documents, use of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries for all studies at the Satellite site(s).
Clinical Research Coordinator - Brighton Dana-Farber Cancer Institute IncClinical Research Coordinator - BrightonMA$48,100–$54,400 / yearThe Clinical Research Coordinator will work within the Brighton Dana-Farber Satellite clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DFCI disease programs. Responsible for data reporting and management, collection of source documents, use of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries for all studies at the Satellite site(s).
MIND Program Clinical Research Assistant II Brigham and Women's HospitalMIND Program Clinical Research Assistant IIBelmont, MA$23.61–$35.29 / hourThe Marijuana Investigations for Neuroscientific Discovery (MIND) Program/Cognitive and Clinical Neuroimaging Core (CCNC) is dedicated to studying the relationship between substance use, cognition, and psychiatric disorders using various magnetic resonance imaging (MRI) techniques and neuropsychological, clinical, and diagnostic instruments. May be responsible for the following activities: making independent judgment of suitability of potential participants for clinical trials, developing and implementing patient recruitment strategies, recommending changes to protocols, managing existing datasets, and overseeing the work of more entry level staff.
Clinical Research Associate II AbbVie IncClinical Research Associate IIBoston, MAApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role atthe time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to aparticular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion,consistent with applicable law.