Clinical Research Associate/Coordinator I

**Job Summary**The 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 participation · Obtain informed consent for sample and data collection protocols · Schedule all protocol required tests and procedures · Coordinate patient appointments with physicians, nurses, and all test areas · Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providers · Prepare pre-visit communication for providers to ensure required assessments are completed and documented · Maintain point of contact communication with enrolled patients and assist with front line questions regarding study participation · Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition · Coordinate, obtain, process, and ship protocol required tissue samples · Ensure collection and processing (e.g. spin/separate/freeze) and storage of all required correlative research blood and tissue samples · Administer quality of life assessments as required for individual studies The 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 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 · Maintain research charts and/or electronic files for all enrolled patients · Ensure adequate source documentation is in place for all data reported · Resolve data queries issued by the sponsor · Obtain protocol clarifications from the study sponsor and communicate information to the research team · Schedule and prepare for monitoring visits with sponsors · Facilitate the request and shipment of archival pathology samples · Organize and prepare for internal and external audits · Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies The following regulatory duties may be performed: · Maintain and organize study specific regulatory binders · Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB · Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study · Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required · Submit Data and Safety Monitoring Reports · Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process · Collect, complete, and submit essential regulatory documents to various regulatory entities · Participate in monitoring visits and file all monitoring visit correspondence · Ensure appropriate documentation of delegation and training for all study staff members · Maintain screening and enrollment logs Skills/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 required Experience · None Supervisory Responsibilities · None Working 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.**Qualifications**EducationBachelor's Degree Related Field of Study requiredCan this role accept experience in lieu of a degree?NoLicenses and CredentialsExperienceClinical Research or compliance experience 1-2 years preferredKnowledge, 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)****Remote Type**Onsite**Work Location**32 Fruit Street**Scheduled Weekly Hours**40**Employee Type**Regular**Work Shift**Day (United States of America)**Pay Range**$20.16 - $29.01/Hourly #J-18808-Ljbffr MGB Anesthesiology