Clinical Research Associate/Coordinator I

MGB Anesthesiology; Boston (MA); Hybrid; USD 28,000 - 40,000; Full time

Job summary

MGB Anesthesiology is seeking a Clinical Research Associate/Coordinator I to enroll eligible patients in cancer studies, manage data collection and submission, and serve as a liaison among the clinical team, sponsor, and IRB.

The role involves regulatory duties, data entry, and patient coordination, with on-site work at Mass General Hospital and Brigham and Women’s Hospital, and potential remote elements.

Qualifications

• BA/BS degree required.
• Experience in clinical research or compliance preferred (1-2 years).
• Ability to interpret data results and follow protocols.

Responsibilities

• Screen potential patients for study participation and obtain informed consent.
• Schedule tests, coordinate patient appointments, and ensure protocol compliance.
• Enter data, verify documents, and manage regulatory submissions.
• Monitor adverse events and maintain source documentation.
• Coordinate with sponsors, IRB, and clinical teams across sites.

Skills

Attention to detail

Organizational skills

Communication skills

Independent work

Team collaboration

Computer literacy

Knowledge of clinical research

Education

Bachelor's Degree

Job description

**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