NewClinical Director BCBA JobotClinical Director BCBABoston, MA$100,000–$130,000 / yearWe are a rapidly growing, BCBA-founded ABA organization committed to delivering compassionate, outcomes-driven autism services across center-based, home-based, school, and community settings. The Clinical Director will partner closely with executive leadership to drive clinical excellence, improve operational outcomes, mentor BCBA Supervisors, and support the continued expansion of services to families across assigned regions.
Clinical Trial Manager IconmaClinical Trial ManagerBoston, MA$26.16–$28.34 / hourAdvise RSP policy owner/committee chair on policy style, writing, programming; collaboration with subject matter experts; alignment of policy directives, procedural job aids, and committee direction. Identify available resources, including needed mentoring, partnerships, for example, SRG, scientific writing core, CCRO, biostats core, IRB, budget development].
Clinical Research Nurse II, Oncology IconmaClinical Research Nurse II, OncologyBoston, MA$70.02–$72.19 / hourCoordinates with clinical research coordinators and collaborates with staff within respective disease groups and with outside organizations in the completion of clinical research trials. Position requires tact and diplomacy to successfully motivate/educate subjects and staff, and knowledge of research regulations and research compliance requirements, including Protection of Human Subjects.
NewDialysis Clinical Manager Registered Nurse - RN Fresenius Medical CareDialysis Clinical Manager Registered Nurse - RNQuincy, MA$99,694–$166,109 / yearOther: • Collaborates closely with, providing oversight as needed to, the Clinical Manager/Charge RN acting as nurse manager, the Medical Director, and the physicians regarding the direct patient care responsibilities within the facility to ensure the provision of outstanding quality of patient care, as defined by the FMS quality goals, and compliance with the pertinent company policies and procedures. • Demonstrated leadership competencies and management skills for the position, including excellent communication, customer service, continuous quality improvement, relationship development, results orientation, team building, motivating employees, performance management and decision making.
Associate Director, Clinical Assay Strategy, Flu CSL SeqirusAssociate Director, Clinical Assay Strategy, FluWaltham, MA$179,000–$212,000This role is intended for a recognized subject matter expert who understands the scientific, operational, and regulatory evolution of influenza immunogenicity assessment, including HAI, microneutralization (MN), ELLA, and multiplex platforms, and can strategically navigate assay modernization while maintaining regulatory alignment. Headquartered in Melbourne, Australia, with major manufacturing hubs in Holly Springs, NC, and Liverpool, UK, the company operates the world’s largest cell-based vaccine facility and serves as a primary partner to governments for global pandemic preparedness.
NewStudent Social Work Clinical Placement Fresenius Medical CareStudent Social Work Clinical PlacementSaugus, MAPRINCIPLE RESPONSIBILITIES AND DUTIES RELATED TO PATIENT CARE: Patient Assessment/Care Planning Counseling: As a member of the interdisciplinary team, assesses patients' psychosocial status, strengths and areas of need that may affect rehabilitation and optimal treatment outcomes as part of the comprehensive patient assessment. Supports the FMCNA commitment to the Quality Enhancement Program (QEP) and CQI Activities, including those related to patient satisfaction and actively participates in process improvement activities that enhance the likelihood that patients will achieve the FMC Quality Enhancement Goals (QEP).
Senior Manager, Special Projects, Center for Clinical Research Advancement Integrated Resources, IncSenior Manager, Special Projects, Center for Clinical Research AdvancementBoston, MAEquipped with extensive experience in program and system design and implementation; integration of research compliance requirements into operational workflows; formation and leadership of institutional committees and workplan initiatives; and career and cultural development, the Senior Manager, Special Projects, is adept in shifting priorities as needed, ready to take on a wide variety of institutional interests. o Recommend process and systems enhancement to Clinical Trial Office Director and collaborate with BClientHS research and non-research departments to implement changes within Client and BClientHS wide systems, including but not limited to, Epic enhancements and other affiliated system integrations.
Clinical Research Manager I - Emergency Department Boston Children's HospitalClinical Research Manager I - Emergency DepartmentBoston, MA$78,540.80–$125,652.80 / yearLead the day-to-day operations, supervision, and development of the Clinical Research team, ensuring staff have the training, resources, and support needed to successfully recruit participants and execute study activities across a portfolio of research studies. Provide ongoing performance management, coaching, and guidance to clinical research staff while ensuring adherence to study protocols, institutional policies, and regulatory requirements; collaborate closely with Principal Investigators to address study needs and priorities.
Assistant Clinical Research Manager - Center of Early Detection & Intervention Blood Cancers Interventional Clinical Trials Dana-Farber Cancer Institute IncAssistant Clinical Research Manager - Center of Early Detection & Intervention Blood Cancers Interventional Clinical TrialsBOSTON, MARemote$70,000–$85,300 / yearThe Assistant Clinical Research Manager (ACRM) position will work within the Center of Early Detection & Intervention Blood Cancers (CEDI BC) Interventional Clinical Trials clinical research program and assist in the management of the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. These positions, in collaboration with the program's Clinical research Managers physicians and research nursing staff, are responsible for assisting with the design, implementation and evaluation of their program's clinical research activities, related regulatory oversight, and will provide day to day supervision of their program's clinical research staff as needed.
Assistant Clinical Research Manager - Breast Oncology Clinical Trials Dana-Farber Cancer Institute IncAssistant Clinical Research Manager - Breast Oncology Clinical TrialsBOSTON, MA$70,000–$85,300 / yearThese positions, in collaboration with the program's Clinical research Managers physicians and research nursing staff, are responsible for assisting with the design, implementation and evaluation of their program's clinical research activities, related regulatory oversight, and will provide day to day supervision of their program's clinical research staff as needed. This Assistant Clinical Research Manager (ACRM) position will work within the Breast Oncology clinical research program and assist in the management of the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator.
Clinical Research Center Manager Joslin Diabetes CenterClinical Research Center ManagerBoston, MAAs needed, provide age specific care to pediatric and adult patients with or without diabetes mellitus in a collaborative practice, by using competencies in history taking, physical examination, assessment and interpretation of laboratory and related diagnostic tools for purposes of screening and safety assessments of participants participating in clinical research studies. The Joslin Clinic Research Center Manager is a practitioner who provides care as well as supervision, management, and leadership to support the daily operations and future direction of the Joslin Clinical Research Center (CRC).
Sr Program Manager - Clinical Research Operations Northeastern UniversitySr Program Manager - Clinical Research OperationsBoston, MA$87,785–$123,998.75 / yearWe are seeking an expert Senior Program Manager of Clinical Research Operations to provide high-level operational, regulatory, and strategic management across multiple active research projects. With the pay range(s) shown above, the starting salary will depend on several factors, which may include your education, experience, location, knowledge and expertise, and skills as well as a pay comparison to similarly-situated employees already in the role.
Senior Manager Clinical Study Lead (Clinical Experimental Sciences) Regeneron Pharmaceuticals IncSenior Manager Clinical Study Lead (Clinical Experimental Sciences)Cambridge, MA$150,500–$245,500 / yearThe CES Ops portfolio is dynamic in nature; study types include, but are not limited to, less complex data transfer agreements, retrospective sample/data acquisition studies to more complex prospective studies including sample/data acquisition, biomarker/technology/method validation, genotypic/phenotypic call back studies, and challenge/screening studies. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study/research collaboration delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study.
NewClinical Research Assistant Adams ClinicalClinical Research AssistantBoston, MA$24–$26.92 / hourWorking under the direct supervision of a CRC II, CRC III, or Site Manager, the RA assists with operational, administrative, and participant-facing tasks to ensure studies run smoothly and in accordance with ICH-GCP, regulatory requirements, and protocol guidelines. Assist with investigational product (IP) accountability tasks as needed and where applicable, gaining exposure to IP handling, tracking, and documentation under the direct supervision of CRC staff, while ensuring adherence to protocol and site SOPs.
Clinical Trial Manager Kymera TherapeuticsClinical Trial ManagerWatertown, MA$115,000–$200,000 / yearHaving advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review.
NewClinical Research Coordinator Brigham and Women's HospitalClinical Research CoordinatorDanvers, MA$21–$29.01 / hourThe 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. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission.
Sr./Clinical Trial Manager - Clinical Operations Aktis Oncology IncSr./Clinical Trial Manager - Clinical OperationsBoston, MAAktis' most-advanced program, AKY-1189, is a miniprotein radioconjugate targeting Nectin-4, with multi-indication potential across multiple tumor types, including locally advanced or metastatic urothelial cancer, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Aktis Oncology, Inc. is a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies.
Senior Manager, Clinical Operations Adams ClinicalSenior Manager, Clinical OperationsWatertown, MA$120,000–$140,000 / yearSupport subject recruitment, eligibility assessments, randomization, and oversee study processes including ALCOA-compliant documentation, study trackers, investigational product handling, and ensure proper handling of participant safety events and adverse events (SAE/AESI reporting). Oversee facility and building maintenance, including office services, safety inspections, drug room security, and pest control, while ensuring efficient use of site space and adequate workspaces for staff.
Clinical Research Program Manager Brigham and Women's HospitalClinical Research Program ManagerBoston, MAThe Center for Precision Psychiatry (CPP) at Mass General Hospital is seeking applications for a full-time Project Manager to work on projects led by Dr. Matthew Nock aimed at better understanding short-term suicide risk and testing innovative new interventions to prevent suicidal behavior. Ideal candidates will bring strong project management abilities, outstanding written and verbal communication skills, advanced organizational and technology skills, and the ability to work independently while building effective relationships across all levels of the organization.
Senior Clinical Research Associate (level dependent on experience) CTISenior Clinical Research Associate (level dependent on experience)Boston, MassachusettsFor that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression – We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward. To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance.
NewClinical Research Biopsy Coordinator Brigham and Women's HospitalClinical Research Biopsy CoordinatorBoston, MA$21–$29.01 / hourThe 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. The primary role of this position is to assume the responsibility for coordination of the scheduling of tissue procurement within the various clinical trial timelines and ensure that the tissue procurement and processing is carried out per clinical trial laboratory manual specifications.
NewClinical Research Coordinator Mass General BrighamClinical Research CoordinatorDanvers, 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. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission.
Clinical Trial Manager ICONMA, LLCClinical Trial ManagerBoston, MA$26.16–$28.34 / hourAdvise RSP policy owner/committee chair on policy style, writing, programming; collaboration with subject matter experts; alignment of policy directives, procedural job aids, and committee direction. Identify available resources, including needed mentoring, partnerships, for example, SRG, scientific writing core, CCRO, biostats core, IRB, budget development].
Clinical Research Program Manager Mass General BrighamClinical Research Program ManagerBoston, MassachusettsThe Center for Precision Psychiatry (CPP) at Mass General Hospital is seeking applications for a full-time Project Manager to work on projects led by Dr. Matthew Nock aimed at better understanding short-term suicide risk and testing innovative new interventions to prevent suicidal behavior. Ideal candidates will bring strong project management abilities, outstanding written and verbal communication skills, advanced organizational and technology skills, and the ability to work independently while building effective relationships across all levels of the organization.
Clinical Research Finance Specialist Iterative Scopes IncClinical Research Finance SpecialistMA$75,000–$85,000 / yearYou will own core transactional AR workflows, including monitoring sponsor and site-level accounts, supporting timely collections, posting cash in RealTime CTMS, and assisting with invoicing as needed. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Senior Clinical Research Finance Specialist Iterative Scopes IncSenior Clinical Research Finance SpecialistMA$85,000–$105,000 / yearYou will own core transactional AR workflows, including monitoring sponsor and site-level accounts, supporting timely collections, posting cash in RealTime CTMS, and assisting with invoicing as needed. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
NewClinical Research Data Specialist I Brigham and Women's HospitalClinical Research Data Specialist IBoston, MA$20.16–$29.01 / hourPrincipal Duties and Responsibilities: The CRDS I will perform the following responsibilities under general supervision by the Clinical Research Manager: Proactively track assigned research subject's upcoming protocol appointments and visits and document on central clinical research data specialist (CRDSP) tracker. General Summary/Overview Statement: The Clinical Research Data Specialist I (CRDS I) works under general supervision to extract clinical data and research data from electronic medical records and other sources and enters this data into electronic data capture system utilized for the clinical research protocol.
Senior Clinical Research Finance Specialist Iterative HealthSenior Clinical Research Finance SpecialistCambridge, MA$85,000–$105,000 / yearYou will own core transactional AR workflows, including monitoring sponsor and site-level accounts, supporting timely collections, posting cash in RealTime CTMS, and assisting with invoicing as needed. We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology.
Clinical Research Finance Specialist Iterative HealthClinical Research Finance SpecialistCambridge, MA$75,000–$85,000 / yearBy combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need. We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology.
Sr. Clinical Research Specialist - Site Ops Iterative Scopes IncSr. Clinical Research Specialist - Site OpsMA$85,000–$105,000 / yearThrough the Iterative Health Site Network - a premier network of 100+ clinical research sites across the US and Europe - we help expand and expedite access to novel therapeutics for patients in need. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Clinical Research Coordinator II - Breast Oncology Dana-Farber Cancer Institute IncClinical Research Coordinator II - Breast OncologyBoston, MA$56,000–$63,700 / yearThe CRC (Clinical Research Coordinators) work within the Breast Oncology 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 and the Clinical Research Manager. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
Sr. Clinical Research Specialist - Site Ops Iterative HealthSr. Clinical Research Specialist - Site OpsCambridge, MA$85,000–$105,000 / yearWe built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology. By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need.
NewClinical Research Biopsy Coordinator Mass General BrighamClinical Research Biopsy CoordinatorBoston, 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. The primary role of this position is to assume the responsibility for coordination of the scheduling of tissue procurement within the various clinical trial timelines and ensure that the tissue procurement and processing is carried out per clinical trial laboratory manual specifications.
Lead Clinical Data Manager Karwell TechnologiesLead 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.
NewClinical Research Data Specialist I Mass General BrighamClinical Research Data Specialist IBoston, MassachusettsPrincipal Duties and Responsibilities: The CRDS I will perform the following responsibilities under general supervision by the Clinical Research Manager: · Proactively track assigned research subject’s upcoming protocol appointments and visits and document on central clinical research data specialist (CRDSP) tracker. General Summary/Overview Statement: The Clinical Research Data Specialist I (CRDS I) works under general supervision to extract clinical data and research data from electronic medical records and other sources and enters this data into electronic data capture system utilized for the clinical research protocol.
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.
Manager, Clinical Research Specialist Training THV AR (Remote US) Edwards Lifesciences CorpManager, Clinical Research Specialist Training THV AR (Remote US)Boston, MARemote$126,000–$178,000 / yearResponsible for maintaining an audit ready environment for all aspects of regulatory and non-regulatory audits as it relates to training (e.g., conducting training, identifying SMEs, ensuring the collection of required documentation.) Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery.
Regional Travel, Clinical Research Coordinator Care AccessRegional Travel, Clinical Research CoordinatorQuincy, MassachusettsRemoteWith programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. The Clinical Research Coordinator’s primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
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 (led by PIs Dr. Kerry Ressler and Dr. Rebecca Fortgang) 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.
Senior Clinical Research Coordinator Beth Israel Lahey HealthSenior Clinical Research CoordinatorBoston, MassachusettsThis position is embedded within the BIDMC Clinical Research Coordinator Core, a centralized resource serving investigators across departments and divisions throughout the medical center, and operating in affiliation with the institution's Clinical Research Center, a member of Harvard Catalyst — Harvard's Clinical and Translational Science Center. Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving.
NewClinical Research Coordinator - Surgery FIRST Program Lahey Hospital and Medical CenterClinical Research Coordinator - Surgery FIRST ProgramBoston, MA$21.64–$26.50 / hourResponsible for screening research subjects for participation in clinical research projects, enrolling research subjects onto these studies, monitoring protocol implementation, completing required forms, reporting results, maintaining regulatory paperwork, and entering data into databases. Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving.
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.
Associate Director, Clinical Supplies Project Manager ModernaTXAssociate Director, Clinical Supplies Project ManagerCambridge, MassachusettsWe are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. The scope includes the operational planning and strategy required to execute end-to-end supply management, including demand planning, label development, packaging/labeling, distribution, IRT UAT/supply management, temperature excursions, and site activations.
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 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.
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 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.
Manager Clinical Data Monte Rosa Therapeutics, IncManager Clinical DataBoston, MassachusettsFull timeThis individual will work closely with Clinical Operations, Biostats and Programming, Medical, Safety, Regulatory, external CROs, and technology vendors to ensure high-quality, inspection-ready clinical data. Manage CROs, EDC vendors, central labs, imaging vendors, eCOA providers, IRT vendors, and other data providers.
NewAssociate Director, Clinical Data Management, Hybrid Merck & Co IncAssociate Director, Clinical Data Management, HybridBoston, MA$142,400–$224,100 / yearor B.S. degree, preferably in life sciences, computer science, or related discipline, with at least 6 years' experience in Clinical Data Management or a mix between Data Management and Clinical Research and at least 3 years' experience working with formal project management tools and processes -OR-. Principle Trial Managers will possess end-to-end data management knowledge with strong project management and leadership skills which are transferable from pipeline to process to special initiatives.