Clinical Research Associate/Coordinator I

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

Job summary

Mass General Brigham in Boston is seeking a Clinical Research Associate/Coordinator I (CRA/CRC I) to enroll eligible patients, manage data collection, and liaise with the clinical team, sponsor, and IRB. The role involves direct patient contact and regulatory duties.

This onsite position supports multiple cancer studies, with 40 hours weekly, pay range $20.16 to $29.01 per hour, and seeks 1–2 years of clinical research or compliance experience.

Qualifications

• Bachelor's Degree required
• No substitutions allowed for degree

Responsibilities

• Screen potential patients for study participation
• Schedule protocol required tests and procedures
• Coordinate patient appointments with physicians, nurses, and test areas
• Manage data entry and regulatory documentation
• Monitor adverse events and deviations and report as required
• Prepare regulatory binders and submit regulatory documents

Skills

Work independently

Analytical skills

Attention to detail

Organizational skills

Communication skills

Clinical research protocols

Education

Bachelor's Degree

Job description

## Clinical Research Associate/Coordinator IApply: Onsite: Boston-MA: Full time: Posted Today: RQ4084786Site: The General Hospital CorporationMass 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 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 - 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) of all required correlative research blood samples with the coordination of the MGH Sample Processing Lab (SPL) - Obtain vital signs and perform EKGs as required for individual studies - 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**Qualifications**Education Bachelor's Degree 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 the 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**125 Nashua Street**Scheduled Weekly Hours**40**Employee Type**Regular**Work Shift**Day (United States of America)**Pay Range**$20.16 - $29.01/Hourly**Grade**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, 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.