Clinical Research Associate/Coordinator I

Clinical Research Associate/Clinical Research Coordinator IMass 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 SummaryThe Clinical Research Associate/Clinical Research Coordinator I (CRA/CRC I) works under general supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. The CRA/CRC I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA/CRC I will be trained on the institutional and federal regulations governing clinical research. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination. The position involves direct patient contact.Principal Duties and Responsibilities:All duties will be performed under general supervision by the Clinical Research Manager.The following clinical duties will be performed:Assist clinical team in screening potential patients for study participationObtain informed consent for sample and data collection protocolsSchedule all protocol required tests and proceduresCoordinate patient appointments with physicians, nurses, and all test areasCoordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providersPrepare pre-visit communication for providers to ensure required assessments are completed and documentedMaintain point of contact communication with enrolled patients and assist with front line questions regarding study participationDevelop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisitionCoordinate, obtain, process, and ship protocol required tissue samplesEnsure collection and processing (e.g. spin/separate/freeze) and storage of all required correlative research blood and tissue samplesAdminister quality of life assessments as required for individual studiesThe following data management responsibilities will be performed:Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteriaEnroll patients as required by the study sponsor and internal enrollment monitor teamFollow patients for the duration of study participation via electronic medical record review to ensure protocol complianceComplete 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 regulationsMaintain research charts and/or electronic files for all enrolled patientsEnsure adequate source documentation is in place for all data reportedResolve data queries issued by the sponsorObtain protocol clarifications from the study sponsor and communicate information to the research teamSchedule and prepare for monitoring visits with sponsorsFacilitate the request and shipment of archival pathology samplesOrganize and prepare for internal and external auditsMaintain ongoing communication with clinical team regarding study patients and progress for multiple studiesThe following regulatory duties may be performed:Maintain and organize study specific regulatory bindersPrepare and submit protocol amendments, continuing reviews, and safety reports to the IRBRevise informed consent documents to include new risk information and/or updated protocol requirements through the course of the studyManage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as requiredSubmit Data and Safety Monitoring ReportsMaintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial processCollect, complete, and submit essential regulatory documents to various regulatory entitiesParticipate in monitoring visits and file all monitoring visit correspondenceEnsure appropriate documentation of delegation and training for all study staff membersMaintain screening and enrollment logsSkills/Abilities/Competencies Required:Careful attention to detail, good organizational skills, ability to follow directions, good communication skills, computer literacy, working knowledge of clinical research protocols, ability to demonstrate respect and professionalism for subjects rights and individual needs.Education: BA/BS degree requiredExperience: NoneSupervisory Responsibilities: NoneWorking Conditions: Duties will be performed primarily on-site in ambulatory and laboratory setting. Duties will be performed at both Massachusetts General Hospital and Brigham and Women's Hospital. Components of the data/regulatory role may allow for remote work.Pay Range: $20.16 - $29.01/HourlyGrade: 5At 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 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 View phone number on click.appcast.io.Mass General Brigham Competency FrameworkAt 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.