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Clinical research coordinator jobs in Massachusetts - 334 jobs

  • Clinical Research Director, Immunology & Inflammation (Rheumatology)

    Sanofi 4.3company rating

    Clinical research coordinator job in Cambridge, MA

    The Clinical Research Director in Immunology & Inflammation (Rheumatology) leads clinical development strategies and coordinates cross-functional teams to advance therapies for autoimmune and inflammatory diseases. This role involves designing clinical trials, ensuring regulatory compliance, engaging with health authorities, and collaborating with external experts to progress drug discovery and development. The director contributes scientific expertise, facilitates study execution, and represents the company at scientific and regulatory forums. Job title: Clinical Research Director in Immunology & Inflammation (Rheumatology) Location: Cambridge, MA / Morristown, NJ About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Position Overview: The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in rheumatologic diseases, incorporate new methodologies, and pro-actively progress study execution. The role will focus on developing innovative therapies for autoimmune and inflammatory diseases, with a particular emphasis on rheumatology. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Create clinical development strategy and plans for one or more assets Lead and coordinate cross-functional teams to design, implement, and execute clinical development plans and studies Align clinical development strategy with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing Advance the clinical development plan through internal management review Lead a clinical sub team to design clinical studies and to create study protocols Execute the clinical development plan in close collaboration with clinical operations Advance scientific and clinical knowledge for immunology in rheumatologic diseases Incorporate new trial, scientific and digital methodologies Pro-actively progress study execution Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval Engage with health authorities (contribute to health authority submissions (such as new drug application) and timely response to regulatory reviews) Serve as a medical expert and provide strategic input to early-stage programs Collaborate with external experts, key opinion leaders, and investigators to advance clinical research Represent Sanofi at scientific conferences and regulatory meetings About You Experience / Skills: MD or MD/PhD in a relevant scientific discipline 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 Experience/enthusiasm in advancing assets from discovery into clinical development (experience in pharma or academia) Have experience in novel approaches to translational medicine Have and maintain deep scientific, technical and clinical knowledge in immunologic/rheumatologic diseases Expertise in autoimmune and inflammatory diseases, particularly in rheumatology Demonstrate problem solving skills Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area Strong leadership skills with the ability to influence and collaborate effectively in a matrix environment Excellent communication and presentation skills, with the ability to articulate complex scientific concepts to diverse audiences Proven track record of scientific publications and presentations at international conferences Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here. Keywords: clinical research director, immunology, rheumatology, inflammation, clinical development, pharmaceutical industry, drug discovery, clinical trials, regulatory compliance, autoimmune diseases
    $75k-116k yearly est. 2d ago
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  • Director of Research Nursing, Cancer Clinical Trials Office

    Beth Israel Lahey Health 3.1company rating

    Clinical research coordinator job in Boston, MA

    When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.This position will operate out of an office location at 133 Brookline Ave, Boston MA (Fenway Area) as well as the BIDMC main campus.Job Summary: The BIDMC Nursing Mission is to build on a legacy of nursing excellence by caring with compassion, advancing the art & science of nursing, and advocating for the health of patients, families, and communities. The Nursing Director for the Cancer Clinical Trials Office (CCTO) reports directly to the CCTO Director. The Nursing Director supervises the CCTO research nursing staff and coordinates nursing coverage for trials, including directly working on clinical trials. The Nursing Director is responsible for working with the Director in the oversight of the Research Nurses. This role will work closely with the Research Clusters, Pharmacy and Disease Program Leaders to directly staff clinical trials and in managing the research nurses to achieve individual programmatic goals. The Nursing Director will contribute to the development, maintenance and implementation of training for Research Nurses. The Nursing Director will train new Research Nurses by providing continuing education to ensure high standards of clinical research practice. This position works closely with senior staff members to plan, prioritize and implement operational goals, as well as establish appropriate quality control procedures to ensure compliance with federal, state, local, and institutional guidelines. Training, evaluation and competencies for this role are overseen by an Accountable Nurse Leader to the department. Job Description:Essential Responsibilities: Works closely with the CCTO Director in the development of operational goals and optimal operating environment. Responsible for developing and implementing Standard Operating Procedures (SOPs) for CCTO Research Nursing and managing staffing of protocols across the CCTO.In collaboration with the disease team leaders, takes a lead role in the hiring, supervision and evaluation of CCTO Research Nurses and directly staffs protocols as needed.Works closely with Disease Program Investigators to provide input on feasibility of new trials and provides nursing and clinical research expertise to investigators during the course of a trial which may include direct work on clinical trials.Interfaces with PCS and professional nursing through collaboration with the Associate Chief Nurse for Prof Development and Rsch and other nursing leaders; operationalizes core values of the organization; develops and sustains excellence in clinical nursing practice and the care of patients and families; serves as a member of the Nursing Leadership Nurses Council and other leadership forums.Collaborates with CCTO Director to develop and implement appropriate quality control guidelines to ensure all study conduct activities conform to Institutional regulatory standards, Good Clinical Practice (GCP), national cooperative group standards and other applicable state, federal and local regulatory requirements.Has the authority to direct and support employees daily work activities. Has authority to undertake or recommend the following employment actions: hiring, termination, corrective action and performance reviews. Direct Reports: More than 7 Indirect Reports: 11-20Required Qualifications:Bachelor's degree in Nursing required. Master's degree in Nursing and/or oncology based clinical specialty preferred. License Registered Nurse required., and Certificate 1 Basic Life Support required.5-8 years related work experience required and 0-1 years supervisory/management experience required Four to six years of clinical research experience, preferably focused in Oncology or other high risk research specialty and proven competence in industry, cooperative group and investigator-initiated sponsored research.Demonstrated analytical experience to effectively manage large-scale, highly visible projects.Strong understanding of policy and practice governing research compliance within a large institution and ability to operationalize evolving research policy (IRB, FDA, OHRP, DHHS) relating to human subjects research.Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access.Preferred Qualifications:Personnel management/mentoring experience to effectively manage a large and diverse staff.Competencies:Decision Making: Ability to make decisions with significant, broad implications for the management and operations of a major department or multiple departments. Participates in decisions on overall strategy and direction of the organization.Problem Solving: Ability to address problems that are broad, complex and abstract, often involving Medical Center-wide issues and requiring substantial creativity, resourcefulness, staff engagement, Lean diagnostic techniques, negotiation and diplomacy to develop solutions.Independence of Action: Ability to set direction and vision for major departments or multiple departments. Establishes priorities, develops policies and allocates resources.Written Communications: Ability to communicate complex information in English effectively in writing to all levels of staff, management and external customers across functional areas.Oral Communications: Ability to verbally communicate complex concepts in English and address sensitive situations, resolve conflicts, negotiate, motivate and persuade others.Knowledge: Ability to demonstrate broad and comprehensive knowledge of theories, concepts, practices and policies with the ability to use them in complex and/or unprecedented situations across multiple functional areas.Team Work: Ability to lead collaborative teams for larger projects or groups both internal and external to the Medical Center and across functional areas. Results have implications for the management and operations of multiple areas of the organization.Customer Service: Ability to lead operational initiatives to meet or exceed customer service standards and expectations in assigned unit(s) and/or across multiple areas in a timely and respectful manner.Age based Competencies: Employees in this job must be competent to provide patient care to the following age groups: Young adult: 16-30 years, Middle Age: 30 - 60 years, Elderly: 60 -.Physical Nature of the Job:Light work: Exerting up to 20 pounds of force frequently to move objects. Some elements of the job are sedentary, but the employee will be required to stand for periods of time or move through out the hospital campus Pay Range: $180,000.00 USD - $230,000.00 USDThe pay range listed for this position is the annual base salary range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) as a condition of employment.More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.Equal Opportunity Employer/Veterans/Disabled
    $180k-230k yearly 2d ago
  • Senior Clinical Research Coordinator- Angelman Syndrome

    Boston Childrens Hospital 4.8company rating

    Clinical research coordinator job in Boston, MA

    Job Posting Description The Division of Genetics and Genomics at Boston Children's Hospital is seeking an experienced Clinical Research Coordinator to assist with clinical research projects that focus on Angelman syndrome in both children and adults. The primary role will be to oversee the operations of a large investigator-initiated, multi-center natural history study of Angelman Syndrome. Key Responsibilities Assisting Principal Investigators (PI) with designing and implementing clinical research protocols, including: coordinating the preparation of protocol applications for Institutional Review Board (IRB) submissions, managing stakeholder contracts, ensuring regulatory compliance across study sites, and overseeing the day-to-day activities of the study. Delivering regular updates and progress reports to PIs and sponsors, including organizing and leading steering committee sessions focused on continuous improvement. Conducting virtual and in-person study site visits (pre-study, initiation, monitoring, and close-out) and ensuring sites complete deliverables within given timelines. Maintaining multiple study databases by coordinating data entry and updates, optimizing data retrieval processes, and enhancing user interface and system performance. Routinely review and verify study data for accuracy and completeness. Creating and implementing subject recruitment and enrollment strategies for study sites. Developing case report forms (CRFs), protocols, training manuals, and other study related documents. Preparing conference presentations and manuscripts by cleaning and preparing datasets for analyses. Minimum Qualifications Education: Bachelor's Degree required, Master's Degree preferred Experience: Bachelor's Degree with 4 years of relevant work experience; OR Master's Degree and 2 years of relevant work experience Strong quantitative and analytical skills, including use of statistical software and programming languages such as R or Python Interested in working with children and adults with severe physical and intellectual disabilities, and their families Excellent interpersonal as well as oral and written communication skills Willingness to work flexible hours, as and when required
    $47k-64k yearly est. 2d ago
  • Senior Clinical Trial Manager

    Clinical Dynamix, Inc.

    Clinical research coordinator job in Waltham, MA

    Senior Clinical Trial Manager Description Reporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with the company's strategic goals. The level reflects the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs. This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week. Responsibilities (including, but not limited to): Accountable for project related efforts for the delivery of studies or programs that are critical to a product's clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines. Supports external vendor selection and management process and assists in the development of RFP's and vendor oversight plans. Provide clinical leadership to CROs, other vendors, CRA team, and CTAs. Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines. Project leadership of the cross-functional study team, including external team members, CROs and vendors. Plan, negotiate, and manage site budgets as well as facilitate site contracting process. Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones. May provide technical advice to team members. Disseminate clinical program communications to all functional groups and leads program, study and team meetings. Interact with clinical research investigators, Key Opinion Leaders and sites. Interact with Senior Management to report on progress of milestones. Oversight of study team and site training Facilitation of Quality processes and Quality Assurance interactions for assigned project(s) Management of study drug distribution and accountability processes and documentation Oversight of study start-up, study management, data cleaning, and study closeout activities Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms. Requirements BA/BS degree in Health or Life Sciences required, advanced degree preferred A minimum 8+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role Exceptional communication and interpersonal skills Positive team orientated attitude Must speak fluent English if it is their second language Advanced proficiency in Microsoft Office and Microsoft Project Reliable, self-motivated, team player Detail oriented with excellent organizational skills Ability to effectively manage multiple tasks and competing priorities in a fast-paced environment Creative problem solver Strong commitment to ethical standards Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.) Ability to travel as needed The salary range for this position is commensurate with experience
    $76k-122k yearly est. 60d+ ago
  • (Senior) Clinical Trial Manager

    Bicara Therapeutics

    Clinical research coordinator job in Boston, MA

    The (Senior) Clinical Trial Manager will be based in Boston and work within the clinical trial team to provide trial oversight in the European region. They will ensure deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The position will report to the Associate Director, Clinical Operations. This role may work collaboratively on one trial or across several trials to support clinical operations activities. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities Support the clinical operations strategy of high-touch, patient-centered clinical trials with a strong focus on adaptive and seamless designs to support registration. Support clinical operations team in ensuring all trial deliverables are met according to timelines, budget, operational procedures, and quality standards. Assigned responsibilities can include development of specific sections of related study documents (e.g., sections of the lab manual); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans. Work closely with external collaboration partners with a focus on relationship management and efficiency Lead the proactive identification, assessment, and management of clinical study challenges and risks. Support the oversight of all study activities including site identification and selection, enrollment models, clinical supply planning, budget planning and trial execution. Monitor oversight of study progress including: CRO and third-party vendors, ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs, as applicable. Work with CRO to develop and/or revise scope of service agreements, budgets, plans and detailed timelines and ensure that performance expectations are met. Participate in the development and authorship of study documents including protocol, investigator brochure, informed consent, etc. Participate in Case Report Form design and user acceptance testing in partnership with Data Management as well as data monitoring over the course of the study. Oversee study management and/or clinical development teams (CROs) to facilitate clinical development goals and achievement of study quality metrics. Execute CRO/Third Party Oversight Activities including but not limited to: Monitoring visit report review, periodic review of data quality, review of CRO/Vendor KPIs, performing Sponsor Oversight Visits, etc. Contribute to and/or author clinical sections of regulatory documents including Investigators' Brochures, safety updates, and responses to Health Authority / Ethics Committee questions. Qualifications Bachelor's Degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). Minimum of 3-5 years clinical trial management experience in the pharmaceutical, biotech and/or CRO industry. Experience in oncology studies and/or Phase 3 trials highly preferred. Requires clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors. Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details. Experience and ability to manage global or regional teams in a virtual environment. Experience with Phase 2 to Phase 3 studies highly preferred. Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues. Must be adaptable and enjoy working in a fast-paced environment. Effective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables. Willingness to travel up to 10-20% of the time. Company Overview Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara's lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit**************** follow us on LinkedIn or X. Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply. Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
    $76k-122k yearly est. 2d ago
  • Clinical Research Coordinator BWH Emergency Medicine

    Brigham and Women's Hospital 4.6company rating

    Clinical research coordinator job in Boston, MA

    Site: The Brigham and Women's Hospital, Inc. 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. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The Division of Clinical Research at the Mass General Brigham Department of Emergency Medicine is looking for motivated individuals to support various ongoing clinical research projects, such as infectious disease, neurology, cardiovascular critical care, digital health, behavioral health emergencies, advanced care planning, point-of-care ultrasound (POCUS), and the use of artificial intelligence in medicine. Responsibilities include screening, recruiting, and conducting study procedures in emergency departments, inpatient units, ICUs, endoscopy suites, and outpatient facilities. The role will involve rotating between Brigham and Women's Hospital, an academic medical center, and Brigham and Women's Faulkner Hospital, a community hospital. Some overnight shifts may be required based on study protocols, and weekend coverage will be needed about once a month. This position is well-suited for those interested in graduate studies or a career in medicine, public health, or clinical research, offering significant patient interaction as part of a clinical research team. Please submit your (1) resume, (2) cover letter, and (3) transcript. Address your cover letter to MGB EM Director of Clinical Research. Your cover letter should include at least the following: Career aspirations Earliest start date Time commitment (e.g. two years) Experience in patient care/interaction Job Summary Summary Following 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.; maintaining and updating data generated by the study. Does this position require Patient Care? No Essential Functions Reviews proposals for compliance with sponsor and organizational guidelines; verify all sponsor requirements are met. Recruiting patients for clinical trials, conducts phone. Verifies the accuracy of study forms and updates them per protocol. Prepares data for analysis and data entry. Documents patient visits and procedures. Assists with regulatory binders and QA/QC Procedures. Assists with interviewing study subjects. Assists with study regulator submissions. Qualifications Education Bachelor's Degree Science required Licenses and Credentials EMT preferred Bilingual in Spanish and English preferred (proficiency will be assessed) Experience Some relevant research project work 0-1 year preferred Knowledge, Skills and Abilities Careful attention to detail and good organizational skills. Ability to follow directions. Good interpersonal and communication skills. Computer literacy. Working knowledge of clinical research protocols. Ability to demonstrate respect and professionalism for subjects' rights and individual needs. Additional Job Details (if applicable) Physical Requirements Standing Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%) 20lbs - 35lbs Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) Remote Type Onsite Work Location 45 Francis Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Rotating (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 2200 The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The 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. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $19.8-28.4 hourly 2d ago
  • Senior Clinical Research Coordinator

    Massachusetts General Hospital 4.7company rating

    Clinical research coordinator job in Boston, MA

    Massachusetts General Hospital and Harvard Medical School are seeking a highly motivated candidate to join the Immunobiology Laboratory. The role focuses on innovative clinical trials for the treatment of type 1 diabetes using the BCG vaccine, with opportunities to gain hands-on experience in regulatory medicine and translational research. Full time, 100% onsite and predominately early morning visits starting at 700AM, M-F. Anticipated working hours are 7AM-4PM. The CRC-Senior will oversee program-wide regulatory and operational needs across multiple supportive care research studies. In addition to contributing to projects employing qualitative methods, survey data, and clinical trial designs, the CRC-Senior will help develop and implement standard operating procedures, onboard and train junior clinical research coordinators (CRCs), and ensure high-quality study execution and compliance. This position is ideal for candidates with prior research experience who are ready to take on supervisory and program development responsibilities. Key Responsibilities Leadership & Training Train, and mentor entry-level CRCs, ensuring adherence to standard operating procedures and best practices. Study Coordination Provide an extra layer of support in managing studies, including participant eligibility reviews, recruitment, informed consent, and coordination of study visits. Assist with data collection (surveys, interviews, chart reviews) and quality control checks, using REDCap (Research Electronic Data Capture) or other programs. Regulatory & Compliance Prepare and maintain Institutional Review Board (IRB) protocol submissions, amendments, continuing reviews, and adverse event reports. Ensure compliance with study protocols, Human Subjects and Good Clinical Practice guidelines, and institutional policies. Assist in coordinating Data Safety Monitoring Board (DSMB) meetings. Update and review Standard Operating Procedures (SOPs). Program Development Assist in developing standard operating procedures and quality assurance systems. Contribute to creation of study templates and guidance for protocol design, database management, and grant submissions. Qualifications Education & Experience Bachelor's degree required (health sciences, psychology, public health, nursing, or related field preferred) Minimum of 5 years of post-baccalaureate research experience in clinical trials or human subjects research, including direct experience with IRB/regulatory documentation. Skills & Competencies Ability to oversee, train and evaluate others effectively. Strong organizational, time management, and problem-solving skills. Excellent interpersonal and written/verbal communication skills. Ability to work independently and collaboratively across multiple investigators and teams. Familiarity with REDCap and other data capture systems preferred.
    $45k-61k yearly est. 2d ago
  • Clinical Associate Professor, Finance Department, Questrom School of Business

    Boston University 4.6company rating

    Clinical research coordinator job in Boston, MA

    Boston University invites applications for a faculty position at the rank of non-tenure track Clinical Associate Professor in the Finance Department in the Questrom School of Business. The anticipated start date for this position is July 1, 2026. We seek outstanding candidates who would be comfortable with, stimulated by, and engaged with both graduate and undergraduate students as well as corporate partners. Candidates with relevant experience in the industry are encouraged to apply. Faculty will be expected to teach undergraduate and graduate courses in asset pricing and corporate finance. The candidate is expected to engage with the MSc in Finance, including academic direction of this program. Applicants must possess, or be near completion of, a PhD in Finance or a related field by the start of employment. Salary will be commensurate with experience. The Questrom School of Business offers generous research and teaching support. The salary range for Clinical Associate Professors at the Questrom School of Business is $174,100 - $202,520. Since its founding in 1839, Boston University has embraced a mission of openness and access, becoming one of the first universities in the nation to welcome all students of ability regardless of race, gender, or creed. That tradition shapes our enduring commitment to academic freedom, free inquiry, and the robust exchange of ideas. We seek scholars who will contribute to our community of teachers and researchers through excellence in innovative scholarship, engaged teaching, and participation in the intellectual life of the University. Boston University provides an environment where faculty and students work together across disciplines, perspectives, and experiences to advance knowledge and address society's most pressing challenges. Required Skills We seek outstanding candidates who would be comfortable with, stimulated by, and engaged with both graduate and undergraduate students as well as corporate partners. Candidates with relevant experience in the industry are encouraged to apply. Faculty will be expected to teach undergraduate and graduate courses in asset pricing and corporate finance. The candidate is expected to engage with the MSc in Finance, including academic direction of this program. Applicants must possess, or be near completion of, a PhD in Finance or a related field by the start of employment. How to Apply Applicants should submit a cover letter specifying the position the candidate is applying for, a complete curriculum vitae, three reference letters, and up to three recent publications or working papers in electronic (PDF) format to *****************. While we will accept applications until we fill the position, we strongly encourage interested candidates to apply by January 30, 2026. To ensure full consideration, candidates are encouraged to apply early. Boston University is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, age, national origin, ethnicity, disability, veteran status, or any other characteristic protected by law or identified in the University's Notice of Non-Discrimination. Retaliation is also prohibited. We are a VEVRAA Federal Contractor. Under Massachusetts law, we may not require or administer a lie detector test as a condition of employment or continued employment. Boston University, consistent with the AAU's Principles on Preventing Sexual Harassment, conducts background checks for final candidates for certain faculty and staff positions. As part of this process, we ask current and past employers of the last seven years whether there has been a substantiated finding of sexual misconduct under their policies. To move forward, final candidates must complete and sign an "Authorization to Release Information" form after receiving an offer to enable this background check.
    $174.1k-202.5k yearly 2d ago
  • Senior Clinical Research Coordinator

    Massachusetts Eye and Ear Infirmary 4.4company rating

    Clinical research coordinator job in Boston, MA

    Site: The General Hospital Corporation 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. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary The MGH CORE Program is seeking a full-time Senior Clinical Research Coordinator (CRC-Senior) to join our multidisciplinary team. This position offers the opportunity to take on a leadership role in advancing innovative supportive care research in oncology and palliative care. The MGH CORE Program brings together oncologists, palliative care specialists, psychiatrists, psychologists, nurses, and other allied clinician researchers dedicated to improving the quality of care and outcomes for patients and families facing cancer and serious illness. Senior Clinical Research Coordinator (CRC) The CRC-Senior will oversee program-wide regulatory and operational needs across multiple supportive care research studies. In addition to contributing to projects employing qualitative methods, survey data, and clinical trial designs, the CRC-Senior will help develop and implement standard operating procedures, onboard and train junior clinical research coordinators (CRCs), and ensure high-quality study execution and compliance. This position is ideal for candidates with prior research experience who are ready to take on supervisory and program development responsibilities. Qualifications Key ResponsibilitiesLeadership & Training Train, and mentor entry-level CRCs, ensuring adherence to standard operating procedures and best practices. Assist CORE faculty investigators with allocating workload and providing ongoing feedback. Study Coordination Provide an extra layer of support in managing CORE studies, including participant eligibility reviews, recruitment, informed consent, and coordination of study visits. Assist with data collection (surveys, interviews, chart reviews) and quality control checks, using REDCap (Research Electronic Data Capture) or other programs. Regulatory & Compliance Prepare and maintain Institutional Review Board (IRB) protocol submissions, amendments, continuing reviews, and adverse event reports. Ensure compliance with study protocols, Human Subjects and Good Clinical Practice guidelines, and institutional policies. Program Development Assist in developing standard operating procedures and quality assurance systems. Contribute to creation of study templates and guidance for protocol design, database management, and grant submissions. Qualifications Education & Experience Bachelor's degree required (health sciences, psychology, public health, nursing, or related field preferred) Minimum of 2-5 years of post-baccalaureate research experience in clinical trials or human subjects research, including direct experience with IRB/regulatory documentation. Skills & Competencies Ability to oversee, train and evaluate others effectively. Strong organizational, time management, and problem-solving skills. Excellent interpersonal and written/verbal communication skills. Ability to work independently and collaboratively across multiple investigators and teams. Familiarity with REDCap and other data capture systems preferred. Application Instructions Please submit your resume and a cover letter (maximum 300 words) describing your background, interest in supportive care research, and what makes you a strong candidate for this leadership role. We value team members from diverse backgrounds and encourage applicants to share in their cover letter how their unique experiences, perspectives, or interests would contribute to our program's mission. Additional Job Details (if applicable) Remote Type Onsite Work Location 125 Nashua Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $49,504.00 - $72,404.80/Annual Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The 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. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $49.5k-72.4k yearly Auto-Apply 14d ago
  • Associate Director - Clinical Research Scientist

    Eli Lilly and Company 4.6company rating

    Clinical research coordinator job in Boston, MA

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: Verve, a wholly owned subsidiary of Eli Lilly, is seeking an Associate Director - Clinical Research Scientist (CRS) to lead the clinical trial efforts for our innovative gene editing therapies targeting cardiovascular disease. In this key role, the CRS in partnership with the Clinical Research Physician provides scientific oversight and strategic leadership throughout the trial lifecycle, ensuring scientific integrity and regulatory compliance, and patient safety. The CRS collaborates with cross-functional teams in the implementation of clinical trials, the review process for protocols and other clinical documents, publications and data dissemination and will contribute to regulatory submissions and help implement biomarker strategies. This high-visibility position offers the opportunity to drive clinical development and engage with key external stakeholders. The ideal candidate will excel in a fast-paced, dynamic environment and possess strong communication skills and attention to detail. Responsibilities: The primary responsibilities of the Verve Associate Director - CRS are related to early-phase gene editing compounds targeting cardiovascular disease. The CRS is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning Contribute to the development of the overall strategy and early phase clinical plan for development of clinical compounds, focusing on studies required for strategic decisions. Collaborate with pharmacokineticists and statisticians by providing clinical support to the development of models of drug exposure and response (PK/PD modeling and trial stimulation) to optimize dosing regimens. Clinical Research/Trial Execution and Support Design and oversee implementation of Phase lb and Ila/IIb clinical studies. Design and write clinical trial protocols. Participate in investigator identification and selection, in conjunction with clinical team. Interact with consultants and clinical investigators to plan, initiate, and conduct worldwide clinical trials. Review and approve risk profiles, and local informed consent documents as required, to ensure appropriate communication of risk to study subjects. Collaborate with clinical and research teams to implement the clinical biomarker strategy for early phase clinical studies Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, advisory boards) Partners with the medical monitor on oversight of clinical trial activities, including safety reviews and site interactions Leads internal meetings to review topics and develop mitigation plans Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel. Serve as resource to clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Scientific Data Dissemination/Exchange Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Participate in data analysis, development of scientific data dissemination and preparation of final reports. Contribute to the development of presentations, abstracts, and publications emerging from clinical and translational studies Provide congress support (e.g., availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events). Regulatory Support Activities Support/ assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings, and communications and resolution of regulatory issues, including regulatory response. Business/ customer support Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national and possibly international basis. Participate in patent development. Scientific & Technical Expertise and Continued Development Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule. Critically read and evaluate the relevant medical literature; know the status and data in medical field of interest; and keep updated with medical and other scientific developments relevant to the therapeutic area Knowledge of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the development projects. Attend scientific symposia. Other activities include internal and external training activities, peer-review of clinical protocols and reports, and ad hoc scientific consultation within Lilly. The CRS works with late stage development colleagues to plan for meeting patient needs through clinical studies, and outcomes and pharmacoeconomic research. Basic Requirements: Bachlores Degree In Health/Medical/Scientific field with 7+ years of pharmaceutical experience that is directly related to at least one of the following: Drug/Clinical Development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs) Minimum of two years' experience in clinical development Additional Skills/Preferences: 3 + years of clinical experience with Advanced degree Health/Medical/Scientific degree (For example in Pharmacology, Physiology, Microbiology) or related Graduate degree such as DVM, PharmD, PhD, MSN With Advanced Clinical Specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of the following: Minimum 2 of which is in clinical development Has strong knowledge of clinical trial design, regulatory requirements, GCP guidelines, and industry best practices. Demonstrated strong problem-solving and prioritization skills with the ability to resolve trial-related issues and ensure smooth execution. Proven ability to interpret clinical trial data, including safety assessments and efficacy endpoints, and apply it to inform decision-making. Demonstrated leadership skills with the ability to collaborate effectively with cross-functional teams and external stakeholders. Demonstrated excellent communication and presentation skills, with the ability to represent the company at scientific conferences, advisory boards, and regulatory meetings. Ability to develop relationships with key opinion leaders (KOLs), clinical investigators, and contract research organizations (CROs). Familiarity with translational biomarker strategies and integration of early-phase data into clinical development plans is a plus. Ability to travel to clinical sites, conferences, and regulatory meetings as needed. Fluent in English, verbal and written communication Additional Information: Travel 10-15% Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $127,500 - $204,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $127.5k-204.6k yearly Auto-Apply 1d ago
  • Clinical Research Associate - Boston/Northeast

    Icon Plc 4.8company rating

    Clinical research coordinator job in Cambridge, MA

    Clinical Research Associate - Boston ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing * Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. * Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. * Collaborating with investigators and site staff to facilitate smooth study conduct. * Performing data review and resolution of queries to maintain high-quality clinical data. * Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile * Bachelor's degree in a scientific or healthcare-related field highly preferred. * Minimum of 2 years of experience as a Clinical Research Associate. * In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. * Strong organizational and communication skills, with attention to detail. * Ability to work independently and collaboratively in a fast-paced environment. * Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply
    $52k-74k yearly est. 60d+ ago
  • Study Coordinator (Natick, MA)

    Actalent

    Clinical research coordinator job in Natick, MA

    Clinical Research Assistant Needed The role involves monitoring participants using various technology products, collecting data, and ensuring the proper functioning of devices and data collection throughout the study sessions. Great opportunity to gain experience in clinical research! Schedule: * Monday - Friday * 7:30am-3:00pm or 2:00pm-9:00pm *can be flexible* Responsibilities * Consent participants according to protocol and take necessary vitals and measurements (height, weight, EKG) throughout the session. * Ensure participants are properly set up with devices and any monitoring equipment. * Operate several pieces of instrumentation and observe participants using devices during various activities as per protocol. * Ensure data monitoring is functioning properly throughout the session and ensure proper data collection. * Guide participants through the study and support data collection directly. Required Skills * Experience in research and data entry. * Bachelor's Degree in science, exercise science, kinesiology, or biology. * Technical proficiency to operate test devices and perform data entry. * Ability to direct participants through the study, with examples of patient care or people interaction. "Nice to have" Qualifications * Experience in human subject research and data analysis. * Familiarity with gym equipment and clinical research. Pay and Benefits The pay range for this position is $25.00 - $25.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Natick,MA. Application Deadline This position is anticipated to close on Apr 30, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
    $25-25 hourly 60d+ ago
  • Senior Clinical Research Coordinator- Angelman Syndrome

    Children's Hospital Boston 4.6company rating

    Clinical research coordinator job in Boston, MA

    The Division of Genetics and Genomics at Boston Children's Hospital is seeking an experienced Clinical Research Coordinator to assist with clinical research projects that focus on Angelman syndrome in both children and adults. The primary role will be to oversee the operations of a large investigator-initiated, multi-center natural history study of Angelman Syndrome. Key Responsibilities * Assisting Principal Investigators (PI) with designing and implementing clinical research protocols, including: coordinating the preparation of protocol applications for Institutional Review Board (IRB) submissions, managing stakeholder contracts, ensuring regulatory compliance across study sites, and overseeing the day-to-day activities of the study. * Delivering regular updates and progress reports to PIs and sponsors, including organizing and leading steering committee sessions focused on continuous improvement. * Conducting virtual and in-person study site visits (pre-study, initiation, monitoring, and close-out) and ensuring sites complete deliverables within given timelines. * Maintaining multiple study databases by coordinating data entry and updates, optimizing data retrieval processes, and enhancing user interface and system performance. * Routinely review and verify study data for accuracy and completeness. * Creating and implementing subject recruitment and enrollment strategies for study sites. * Developing case report forms (CRFs), protocols, training manuals, and other study related documents. * Preparing conference presentations and manuscripts by cleaning and preparing datasets for analyses. Minimum Qualifications Education: * Bachelor's Degree required, Master's Degree preferred Experience: * Bachelor's Degree with 4 years of relevant work experience; OR Master's Degree and 2 years of relevant work experience * Strong quantitative and analytical skills, including use of statistical software and programming languages such as R or Python * Interested in working with children and adults with severe physical and intellectual disabilities, and their families * Excellent interpersonal as well as oral and written communication skills * Willingness to work flexible hours, as and when required The posted pay range is Boston Children's reasonable and good-faith expectation for this pay at the time of posting. Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.
    $53k-74k yearly est. 9d ago
  • (Senior) Clinical Trial Manager

    Bicara Therapeutics Inc.

    Clinical research coordinator job in Boston, MA

    The (Senior) Clinical Trial Manager will be based in Boston and work within the clinical trial team to provide trial oversight in the European region. They will ensure deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The position will report to the Associate Director, Clinical Operations. This role may work collaboratively on one trial or across several trials to support clinical operations activities. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities Support the clinical operations strategy of high-touch, patient-centered clinical trials with a strong focus on adaptive and seamless designs to support registration. Support clinical operations team in ensuring all trial deliverables are met according to timelines, budget, operational procedures, and quality standards. Assigned responsibilities can include development of specific sections of related study documents (e.g., sections of the lab manual); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans. Work closely with external collaboration partners with a focus on relationship management and efficiency Lead the proactive identification, assessment, and management of clinical study challenges and risks. Support the oversight of all study activities including site identification and selection, enrollment models, clinical supply planning, budget planning and trial execution. Monitor oversight of study progress including: CRO and third-party vendors, ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs, as applicable. Work with CRO to develop and/or revise scope of service agreements, budgets, plans and detailed timelines and ensure that performance expectations are met. Participate in the development and authorship of study documents including protocol, investigator brochure, informed consent, etc. Participate in Case Report Form design and user acceptance testing in partnership with Data Management as well as data monitoring over the course of the study. Oversee study management and/or clinical development teams (CROs) to facilitate clinical development goals and achievement of study quality metrics. Execute CRO/Third Party Oversight Activities including but not limited to: Monitoring visit report review, periodic review of data quality, review of CRO/Vendor KPIs, performing Sponsor Oversight Visits, etc. Contribute to and/or author clinical sections of regulatory documents including Investigators' Brochures, safety updates, and responses to Health Authority / Ethics Committee questions. Qualifications Bachelor's Degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). Minimum of 3-5 years clinical trial management experience in the pharmaceutical, biotech and/or CRO industry. Experience in oncology studies and/or Phase 3 trials highly preferred. Requires clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors. Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details. Experience and ability to manage global or regional teams in a virtual environment. Experience with Phase 2 to Phase 3 studies highly preferred. Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues. Must be adaptable and enjoy working in a fast-paced environment. Effective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables. Willingness to travel up to 10-20% of the time. Company Overview Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara's lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit ************** or follow us on LinkedIn or X. Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply. Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
    $76k-122k yearly est. 2d ago
  • Clinical Research Coordinator-HBCD

    Boston Childrens Hospital 4.8company rating

    Clinical research coordinator job in Boston, MA

    Job Posting Description The Fetal-Neonatal Neuroimaging and Developmental Science Center, Laboratories of Cognitive Neuroscience, and Department of Psychiatry and Behavioral Sciences at Boston Children's Hospital seek to hire a full-time Clinical Research Coordinator responsible for executing all tasks associated with The HEALthy Brain and Child Development Study (HBCD). The study aims to examine brain and behavioral development in children with and without substance exposure and other highly variable environments from pregnancy to 10 years of age. This nationwide, prospective, longitudinal study uses an innovative battery of neuroimaging measures (MRI, EEG), complemented by an extensive armamentarium of behavioral, physiological, and psychological tools as well as assessment of a range of biospecimens, to understand neurodevelopmental trajectories. This project is part of NIH's Helping to End Addiction Long-term (HEAL) initiative. This role has a strong preference for a candidate who is fluent in Spanish as well as someone who is looking to stay in the role for two years (minimum). Key Responsibilities: Assist Principal Investigators (PIs) in implementing the HBCD Study as assigned. Work with and coordinate a large research team. Manage communications with staff at collaborating sites and related organizations within and outside the hospital. Assist with recruitment of study participants for study enrollment. Write/update study protocol/materials as needed. Execute study visits remotely, in the lab, and in participants' homes, including behavioral testing, MRI scanning, EEG data collection, and biological sample handling. Oversee data management. Attend and/or lead study-related meetings. Train collaborators off-site as needed. Organize hiring and training of new research staff. Complete record abstraction of source documents, and complete study data forms. Conduct QC checks of completed data forms ; coordinate resolution of all data queries. Complete data entry as warranted. Comply with all institutional policies and government regulations pertaining to human subjects protections. Maintain regulatory binders, and other study documents. Monitor the occurrence of clinical adverse events. Manage biosample inventory, coordinating with local and collaborating biorepositories. Oversee Institutional Biosafety Committee (IBC) submissions. Monitor and manage equipment, supplies, and purchasing, and coordinate research participant remuneration. Coordinate referrals for participants as needed. Assist investigators in data and/or document preparation as needed, including preparation of analysis results, literature searches, and article retrieval. Minimum Qualifications Education: A Bachelor's degree in STEM or Psychology (or related field) is required, Master's degree is preferred. Experience: Two years of work experience is required. Experience managing a team, and experience working with children. Well-developed communication skills to provide critical information to participants, work collaboratively on a team, effectively deal with conflicting views or issues, and mediate fair solutions. High attention to detail and organizational skills, ability to multi-task, analytical skills to gather and interpret data in which the information or problems are moderately complex to complex. Sensitivity in working with women, infants, and young children from various backgrounds and with varied experiences. Ability to work after daytime hours as needed and be available for weekend study sessions. Must be willing to travel throughout the greater Boston area. Proficiency in using database software, including Microsoft Office (Word, Excel, and PowerPoint)
    $49k-63k yearly est. 2d ago
  • Clinical Research Coordinator I or II

    Brigham and Women's Hospital 4.6company rating

    Clinical research coordinator job in Boston, MA

    Site: The Brigham and Women's Hospital, Inc. 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. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Replacement for Isabella Larizza Job Summary Summary Works independently under general supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. Will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. Does this position require Patient Care? No Essential Functions Coordinate patient appointments with physicians, nurses, and all test areas. Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition. Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all criteria. Enroll patients as required by the study sponsor and internal enrollment monitor team. Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance. Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements. Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations. Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study. Collect, complete, and submit essential regulatory documents to various regulatory entities. Qualifications Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Clinical Research or compliance experience 1-2 years preferred Knowledge, Skills and Abilities Ability to work independently and as a team member. Analytical skills and ability to resolve problems. Ability to interpret acceptability of data results. Careful attention to detail. Good organizational and communication skills. Working knowledge of clinical research protocols. Additional Job Details (if applicable) Physical Requirements Standing Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%) 20lbs - 35lbs Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) Remote Type Hybrid Work Location 60 Fenwood Road Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 2200 The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The 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. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $19.8-28.4 hourly 2d ago
  • Senior Clinical Research Coordinator

    Massachusetts Eye and Ear Infirmary 4.4company rating

    Clinical research coordinator job in Boston, MA

    Site: The Brigham and Women's Hospital, Inc. 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. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. to support new cardiovascular clinical trials Job Summary The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations.The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners Healthcare System regulatory requirements, NIH Guidelines, and HIPAA regulations. Responsibilities: Ongoing support of TIMI investigators with all phases of clinical research to include: Trial Initiation; Trial Coordination/Implementation/Maintenance and Trial Close-out. Trial Initiation: Assist in development of trial protocol IRB application and submit to appropriate authority; prepare and/or review budgets, as required; coordinate and work with ancillary departments/services as needed to successfully execute protocol elements; develop plan for site initiation once IRB protocol approval is received. Trial Coordination/Implementation: Conduct medical record screening of BWH cardiovascular in-patients and out-patients to identify eligible potential trial subjects; be prepared to approach potential subjects, and/or family members with trial specific information for review/consideration; assist in the recruitment of qualified/interested trial participants; maintain accurate case report forms, regulatory binders, and meticulous trial records; schedule and conduct follow-up trial visits; obtain and process biological samples according to protocol (after completing any necessary training); co-manage with pharmacy all trial medications, including receipt and delivery of same; perform data entry for trials using both manual and electronic data capture; submit all study documentation in a timely manner to appropriate data management and core laboratories; submit any amendments to protocol, or informed consent form(s), to the IRB for review & approval; notify sponsors and IRB of all pertinent AEs (Adverse Events) and SAEs (Severe Adverse Events); perform other procedures related to the trial protocol; review completeness and quality of data with trial monitors; apprise the Principal Investigator and co-investigator(s) on a daily basis, as needed, of overall trial progress to include: subject enrollment, subject scheduling, issues/problems as they develop, subject retention and lost to follow-up metrics. Also, submit/track/amend annual protocol Continuing Reviews to the IRB; serve as an informed resource for trial participants and their families; educate ancillary staff and departments regarding trial protocols: develop trial materials as needed; and orient and train new staff. Trial Close-out: Assist with preparation and submission of final trial report to the IRB for review. Prepare all documents/files/binders/electronic data for sponsor-initiated or FDA audits. Other: Maintain department service standards as outlined in the BWH Code of Conduct. Perform other duties as required. Qualifications - External 1. Bachelor's Degree 2. Three to five years of relevant experience in human clinical trial research, with cardiovascular disease experience preferred 3. Knowledge of federal and institutional policies governing human clinical research 4. Proficiency with PCs and windows-based software, including Word, Excel and data management system • Be fluent in English and Spanish (preferred) • Excellent interpersonal skills and ability to work effectively in team environments. • Strong organizational skills with ability to multi-task • Possess good judgment skills with ability to interpret information and protocol requirements, and initiate appropriate actions • Superior written and oral communication skills, to enable working with individuals from various fields of expertise and with trial subjects from various educational/cultural backgrounds • Accomplished documentation skills with meticulous attention to detail • Ability to complete tasks with aggressive deadlines and competing priorities • Ability to safeguard confidential information. • Comfortable with hospital in-patient and out-patient environments EEO Statement Partners HealthCare is an Equal Opportunity Employer & by embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. Qualifications Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Clinical Research or Compliance experience 3-5 years required Knowledge, Skills and Abilities - Exceptional 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 identify problems and develop solutions. - Demonstrated ability to successfully manage multiple projects. Additional Job Details (if applicable) Remote Type Onsite Work Location 350 Longwood Avenue Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $49,504.00 - $72,404.80/Annual Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The 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. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $49.5k-72.4k yearly Auto-Apply 35d ago
  • Senior Clinical Research Coordinator

    Children's Hospital Boston 4.6company rating

    Clinical research coordinator job in Brookline, MA

    The Department of Psychiatry and Behaviroal Sciences is seeking a full-time Senior Clinical Research Coordinator (Sr. CRC) for the Glahn Laboratory and Early Psychosis Investigation Center (EPICenter) at Boston Children's Hospital. This position is integral to a multidisciplinary team of healthcare professionals (researhcers and clinicians) dedicated to advancing research and treatment focused on children and adolescents with psychotic and affective disorders. By focusing on early onset psychiatric diagnoses, we aim to identify the root causes of psychiatric symptoms, and to improve treatment options and outcomes for patients and their families. The Sr. CRC will play a vital role in overseeing daily operations of multiple NIH-funded and foundation-funded studies aligned with these aims.Responsibilities include, but are not limited to: developing and implementing best practices for clinical research protocols; collaborating with the Principal Investigator to manage studies; supervising and train research staff; monitor regulatory compliance to uphold hospital and governmental standards. Our ideal candidate is committed to a long-term tenure with the Glahn Lab and brings at least four years of experience in research study design, management, and coordination. Key Responsibilities * Providing strategic oversight of a research portfolio with minimal supervision. Leading the development and implementation of clinical research projects in collaboration with Principal Investigator and/or designees to ensure targets are met on time. * Developing and implementing enrollment strategies and study documents, including IRB approved research protocols and study materials. Provide analytical, data management, and methodological support in the development of clinical research protocols and data management tools. Assist in the establishment of best practice guidelines for various clinical research protocols. * Desigining comprehensive training curriculum for research support staff and overseeing training and development initiatives. Supervise the day-to-day activities of research support personnel. * Oversee the consent and enrollment process for research study participants. Communicates all relevant policies and procedures to address participation inquiries. Evaluate the suitability and selection of prospective study candidates based on clinical knowledge. * Developing study-specific data management and quality assurance procedures, and ensure compliance at site visits and through periodic review of study data. * Potentially assist in writing grants and preparing new applications for research funding and in implementation and managing ancillary study grants. Minimum Requirements Education * A Bachelor's degree in psychology or related field, with a minimum of 4 years relevant work experience, OR Master's Degree and 2 years relevant work experience * A cover letter describing your interest in the position and articulating why you would be an excellent fit for the Glahn Lab is preferred. Experience * Strong attention to detail and organizational skills * Exceptional communication skills to convey critical information, work collaboratively on a team, and resolve conflicts effectively * Exemplary interpersonal and supervisory skills, to lead by example and mentor research support staff and to foster collaboration within the research team * Ability to manage complex data collection procedures training * Oversee participant interview covering clinically sensitive subject matter * Flexiblity to accomandate a varied schedule, including some evenings and weekends * Willingness to commit long-term to this role The posted pay range is Boston Children's reasonable and good-faith expectation for this pay at the time of posting. Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.
    $53k-74k yearly est. 15d ago
  • Clinical Research Coordinator

    Brigham and Women's Hospital 4.6company rating

    Clinical research coordinator job in Boston, MA

    Site: The General Hospital Corporation 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. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The Neuroendocrine Unit focuses on the neurohormone oxytocin in human physiology and pathophysiology and therapeutic potential in human disease, and the neurobiology of eating disorders and obesity. Specifically, the CRC will support a study investigating the effects of intranasal oxytocin administration on emotional well-being in adults with pituitary disease. The CRC may have the opportunity to be involved in other clinical research studies in the Neuroendocrine unit. In addition to the responsibilities listed, the CRC will also review test results and data with the NPs, study clinicians, and the principal investigator to ensure protocol requirements are met; develop meeting agendas to report on study progress and guide discussion related to agenda topics and document meeting notes; and manage study drug accountability, study supply inventory, and long-term storage of biological samples following institutional biosafety precautions. The CRC will be a resource for subjects and study staff and will serve as the primary contact for urgent clinical research related matters. There may be opportunities to assist with preparing data for abstracts, posters, or manuscripts. Key competencies also include strong analytical skills with the ability to anticipate, identify, and present solutions to resolve problems and working knowledge of clinical research protocols and electronic data capture systems. Additionally, the CRC is expected to be able to manage multiple responsibilities simultaneously and shift priorities as needed and to work independently under NP supervision and as a team player. The CRC must be able to work on-site during normal business hours with the flexibility to attend study visits that may occur during early mornings, late evenings, and weekends. This is a full-time, 2- year position. Job Summary Summary Following 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. Candidates who are in the process of completing their bachelor's degree have a six-month grace period from their hire date (up to one year if starting on a per diem basis) to provide degree equivalency verification. Does this position require Patient Care? No Essential Functions Reviews proposals for compliance with sponsor and organizational guidelines; verifies that all sponsor requirements are met. Recruiting patients for clinical trials and conducting phone interviews. Verifies the accuracy of study forms and updates them per protocol. Prepares data for analysis and data entry. Documents patient visits and procedures. Assists with regulatory binders and QA/QC Procedures. Assists with interviewing study subjects. Assists with study regulator submissions. Qualifications Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Some relevant research project work 0-1 year preferred Knowledge, Skills and Abilities Careful attention to detail and good organizational skills. Ability to follow directions. Good interpersonal and communication skills. Computer literacy. Working knowledge of clinical research protocols. Ability to demonstrate respect and professionalism for subjects' rights and individual needs. Additional Job Details (if applicable) Physical Requirements Standing Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%) 20lbs - 35lbs Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) Remote Type Onsite Work Location 50 Staniford Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The 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. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $19.8-28.4 hourly 2d ago
  • Registered Nurse, Cardiovascular Genetics Research Nurse

    Boston Childrens Hospital 4.8company rating

    Clinical research coordinator job in Boston, MA

    Job Posting Description Cardiovascular Genetics Research Nurse for Pegasus Study on Natural History of Arrhythmogenic Cardiomyopathy The Research Nurse will provide specialized clinical and research support for a longitudinal natural history study investigating PKP2-associated arrhythmogenic cardiomyopathy (ARVC). This individual will coordinate and execute study-related activities involving patient recruitment, clinical assessments, biospecimen collection, data management, and follow-up, in accordance with Good Clinical Practice (GCP) and institutional regulatory requirements. The incumbent will serve as a key member of a multidisciplinary research team including cardiologists, geneticists, imaging specialists, research coordinators, and nurse practitioners, but this position will be focused exclusively on this project. Key Responsibilities Clinical and Research Coordination Coordinates the recruitment, screening, consent, and enrollment of eligible participants into the natural history study. Oversees scheduling and execution of research visits, including ECGs, cardiac imaging, blood draws, exercise testing, cardiac imaging and blood sample collection. Patients over 18 may elect to undergo a right heart catheter and myocardial biopsy. Conducts structured interviews and standardized questionnaires to capture detailed medical and family histories. Ensures the timely completion of study case report forms and source documentation in compliance with institutional and sponsor guidelines. Nursing and Patient Care Performs study-related clinical assessments and procedures within scope of nursing practice (e.g., vital signs, ECG acquisition, specimen handling). Monitors participant safety and well-being throughout study activities; promptly reports and documents adverse events. Provides education to participants and families regarding study procedures, follow-up requirements, and genetic counseling resources. Maintains strict adherence to institutional infection control, patient confidentiality, and research safety standards. Data and Regulatory Compliance Maintains study documentation and research records in accordance with institutional policy, sponsor requirements, and federal regulations (IRB, FDA, HIPAA). Participates in internal audits, data quality reviews, and monitoring visits. Supports the preparation of regulatory submissions, amendments, and annual reports. Collaborates with the research and biostatistics teams to ensure data completeness and integrity. Collaboration and Communication Serves as a central point of contact for study participants, investigators, referring clinicians, and external collaborators. Participates in team meetings, case reviews, and protocol development discussions. Contributes to manuscripts, abstracts, and presentations summarizing study findings as appropriate. Minimum Qualifications Education: Bachelor's degree in nursing (BSN) required; Master's Degree (MSN) preferred. Experience: Minimum of two to three years of relevant clinical or research nursing experience, preferably in cardiology or inherited disease research. Demonstrated knowledge of Good Clinical Practice (GCP), research ethics, and IRB processes. Proficiency in medical record systems (e.g., Epic) and electronic data capture tools (e.g., REDCap). Experience working in cardiovascular genetics or inherited arrhythmia syndromes (e.g., ARVC, HCM, LQTS). Familiarity with natural history or registry-based clinical studies. Prior experience coordinating NIH- or industry-sponsored research. License/certifications: MA RN license required. BLS certification and CITI training. Please note: During a public health emergency, individuals in this role may be expected to take on additional duties to respond to organizational needs.
    $53k-71k yearly est. 2d ago

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