Senior Clinical Trial Manager TScan Therapeutics IncSenior 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 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.
Clinical Research Coordinator Alcanza Clinical Research LLCClinical Research CoordinatorMAScheduling 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;].
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 Project Manager III Integrated Resources, IncClinical Project Manager IIILexington, MassachusettsFull timeLeads cross-functional team and is responsible for the financial management of the study (ies).Responsibilities % of Time Job Function and Description 10 %: Represents and leads the study team to design, develop and deliver the clinical study in accordance with the clinical development plan/strategy, budget and timeline Authors/contributes to clinical study documents. Key Skills, Abilities, and Competencies Strong knowledge of applicable computer and project management software packages, including Microsoft Word, Excel, Project, and Power Point Familiarity with financial budgeting and forecasting or reporting Requires strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
NewClinical Research Coordinator - Dana-Farber Cancer Institute at South Shore Hospital South Shore Health Systems IncClinical Research Coordinator - Dana-Farber Cancer Institute at South Shore HospitalWeymouth, MA$23.89–$32.15 / hourThe Clinical Research Coordinator (CRC) will support the clinical research program and research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager. Participates in continued learning and possess a willingness and ability to learn and utilize new technology and procedures that continue to develop in their role and throughout the organization.
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.
Senior Clinical Study Manager Integrated Resources, IncSenior Clinical Study ManagerCambridge, MassachusettsFull timeProvides Clinical Operations input to other important study activities, including but not limited to: site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans, development of IxRS systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock, writing the Clinical Study Report.9. In collaboration with Study Execution Team (Takeda functions, Strategic Partners, and vendors), identify risks to study and develop risk mitigation plans, including communication and collaboration with Clinical Program Manager and Associate Director, Clinical Operations to escalate risks and ensure rigorous risk mitigation planning.12.
Senior Manager, Clinical Operations - Cardiology Iterative HealthSenior Manager, Clinical Operations - CardiologyCambridge, MA$140,000–$165,000 / yearAs the Senior Manager, Clinical Operations- Cardiology at Iterative Health you will serve as a strategic advisor to sponsors, CROs, and research sites, translating operational challenges into scalable solutions that improve study execution, accelerate activation timelines, and drive patient recruitment performance. By combining deep clinical research expertise with a consultative approach, this individual will help strengthen sponsor relationships, elevate site performance across the network, and contribute directly to Iterative Health's mission of bringing innovative therapies to patients faster.
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.
Senior Clinical Operation Lead Integrated Resources, IncSenior Clinical Operation LeadCambridge, MassachusettsContractorDevelop scientifically robust, operationally feasible and clear protocol concepts and protocols, and feasible protocols and robust data monitoring plansLeverage appropriate on going data review to identify and mitigate patient, study design, data or study conduct issuesEnsure all operational aspects support end point integrity and data validity. Job DescriptionPosition Details:Client Direct ClientLocation Cambridge, MAJob Title Senior Clinical Operation LeadDuration 1year+ (possible extension)Must have skill-set JOB RESPONSIBILITIES:Partners with Medical Research and other functions to develop operationally feasible and clear protocol concepts and final protocols.
NewClinical Research Coordinator - Dana-Farber Cancer Institute at South Shore Hospital South Shore HealthClinical Research Coordinator - Dana-Farber Cancer Institute at South Shore HospitalWeymouth, MAThe Clinical Research Coordinator (CRC) will support the clinical research program and research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager. Participates in continued learning and possess a willingness and ability to learn and utilize new technology and procedures that continue to develop in their role and throughout the organization.
NewClinical Research Coordinator - Dana-Farber Cancer Institute At South Shore Hospital South Shore HealthClinical Research Coordinator - Dana-Farber Cancer Institute At South Shore HospitalWeymouth, MA$23.89–$32.15 / hourThe Clinical Research Coordinator (CRC) will support the clinical research program and research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager. Participates in continued learning and possess a willingness and ability to learn and utilize new technology and procedures that continue to develop in their role and throughout the organization.
Clinical Research Associate Integrated Resources, IncClinical Research AssociateLexington, MassachusettsFull timeJob DescriptionThe in-house Clinical Research Associate (CRA) is responsible for providing support for day to day clinical study activities under general supervision of the Clinical Project Manager(s).The CRA also provides support for existing departmental tasks and may take on developmental tasks as appropriate upon discussions with manager. Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP.Reviews Clinical Monitoring Reports and correspondence related to restudy and Initiation Visits and follows up with Clinical CRO to resolve open action items.
Sr.Clinical Operations Lead Integrated Resources, IncSr.Clinical Operations LeadCambridge, MassachusettsFull timePartnering with GCO Vendor Management to escalate issues, sharing best practices and leveraging the Vendor Operations Relationship Manager for issue resolution• Initiates, leads and shares best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Operation Management group• Identifies interdependencies and synergies with other trials and programs and seeks to proactively put into place process or forum to enhance excellence in planning and execution across all studies in a phase• Follows established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing model; provides feedback via appropriate channels for opportunities to improve processes or set best practices (i.e. PON)• Embodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the CRO partnership model• Is an advocate for the COL group and a visible contributor and vehicle to promote interaction• Is an influential leader and a resource for COLs within the Clinical Operations Management group.• Initiates and leads discussions at peer level forums relevant to the COL role and development in line with GCO best practices.• Able to influence MD on clinical study/program direction based on changing internal and external landscapes within phase, disease or therapeutic area; able to think strategically to best position a study within the current Clinical Development Plan.• Chairs SMT meetings and drives effective and efficient team operations through communication, goal setting and strategy implementation• Has a robust understanding of the study design including rationale, end points and patient population, and will ensure that the operational strategy supports both feasibility and scientific integrity• Develops and leverages Phase expertise (e.g.
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 Manager, Clinical Scientist Vor BioPharma IncSenior Manager, Clinical ScientistBoston, MA$160,000–$175,000 / yearContributes to preparation and/or review of any documents related to the studies and requiring a scientific background (abbreviated protocol/protocol/amended protocol, informed consent form, presentations/communication to internal or external partners, study plans including medical monitoring plan, safety management plan, risk mitigation plan and recruitment materials). Contributes to definition of the centralized monitoring strategy in consistency with the planned statistical analysis and is involved in study data validation and review processes, support the Head of PV for Clinical Case review (all safety events), notably to anticipate and prevent last minute queries or backlog and smoothen the process.
Contracts Assistant Clinical Vendor Management Integrated Resources, IncContracts Assistant Clinical Vendor ManagementCambridge, MassachusettsFull timeDecision Making, Discretion & Latitude•Responsible for ensuring prompt and efficient receipt, signature, delivery, tracking, uploading and archival of all clinical contracts within the CVM group•Follows up on PO process from requisitions through to PO approval•Identifies areas for administrative process improvement and provides suggestionsWith Direction•Initiates purchase order requisitions upon receipt of supporting documentation as needed•May support Vendor Contract Manager in researching contract history and next available appendix informationKnowledge & SkillsMust have excellent communication skills, the ability to work efficiently and to perform tasks simultaneously with minimum supervision in a fast paced environment, exceptional organizational skills with a demonstrated ability to work in an accurate manner, great attention to detail, the ability to exercise sound judgment and determine priorities, the ability to work as part of a dynamic team, the ability to execute activities under tight timelines and high stress situations,proficiency with computers including MS Office suite with emphasis on Excel and Word, and the ability to quickly learn new technologies and processes. Job DescriptionPosition Details:Client Direct ClientLocation Lexington, MAJob Title Contracts Assistant Clinical Vendor ManagementDuration 7+ MonthsMust have skill-set [Job Description] Job SummaryTo work as an integral part of the Clinical Vendor Management (CVM) team providing proactive, high quality contracts administrative support to the global Vendor Contracts Managers (VCMs) in collaboration with the Contracts Associates.
Admin Contracts Assistant-Clinical Vendor Management Integrated Resources, IncAdmin Contracts Assistant-Clinical Vendor ManagementCambridge, MassachusettsContractorIndependent•Responsible for ensuring prompt and efficient receipt, signature, delivery, tracking, uploading and archival of all clinical contracts within the CVM group•Follows up on PO process from requisitions through to PO approval•Identifies areas for administrative process improvement and provides suggestionsWith Direction•Initiates purchase order requisitions upon receipt of supporting documentation as needed•May support Vendor Contract Manager in researching contract history and next available appendix informationMust have excellent communication skills, the ability to work efficiently and to perform tasks simultaneously with minimum supervision in a fast paced environment, exceptional organizational skills with a demonstrated ability to work in an accurate manner, great attention to detail, the ability to exercise sound judgment and determine priorities, the ability to work as part of a dynamic team, the ability to execute activities under tight timelines and high stress situations,proficiency with computers including MS Office suite with emphasis on Excel and Word, and the ability to quickly learn new technologies and processes. This may include collaborating with the Contracts Associate in providing oversight of CROs/FSPs who are contracted to upload contracts on our behalf to ensure commitments are met 20%•Data Cleanup and Migration: Collaborate with Contract Associates and Outsourcing Associate in the review and cleanup and migration of contract data in teams contract organizational tool and legal contract storage system.
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).