Clinical Research Coordinator II, Radiation Oncology at Partner's Healthcare in Boston, Massachusetts

Job Description:

Site: The Brigham and Women's Hospital, Inc.


At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.


At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare - people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds - to apply.



Job Summary
JOB SUMMARY
The Clinical Research Coordinator II works within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DF/HCC Clinical Trials Office and/or Partners HealthCare Institutional Review Board (IRB). The CRC II will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely collection of protocol related samples including shipment to outside entities as required. Maintains regulatory binders and ensures study compliance with all local, state, federal, and IRB requirements. May be responsible for IRB protocol submissions (amendments, continuing reviews, and protocols). This individual may also screen patients for protocol eligibility, obtain informed consent, and register study participants to clinical trials. Essential Functions (Key Roles & Responsibilities) - Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities. - Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries. - Prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis. - Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations. - Responsible for organizing and preparing for both internal and external auditing and study monitoring visits. - Coordination and management of clinical trials, including communication with Sponsors and regulatory authorities. - Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved. - Interact with study participants as directed/required by the protocol and/or study team. - Interact with clinical services to coordinate patient care on protocol - May be responsible for tissue sample work.



Qualifications


The Clinical Research Coordinator II works within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DF/HCC Clinical Trials Office and/or Partners HealthCare Institutional Review Board (IRB). The CRC II will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely collection of protocol related samples including shipment to outside entities as required. Maintains regulatory binders and ensures study compliance with all local, state, federal, and IRB requirements. May be responsible for IRB protocol submissions (amendments, continuing reviews, and protocols). This individual may also screen patients for protocol eligibility, obtain informed consent, and register study participants to clinical trials.


Essential Functions (Key Roles & Responsibilities)

• Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.


• Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries.


• Prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis.


• Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations.


• Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.


• Coordination and management of clinical trials, including communication with Sponsors and regulatory authorities.


• Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved.


• Interact with study participants as directed/required by the protocol and/or study team.


• Interact with clinical services to coordinate patient care on protocol


• May be responsible for tissue sample work.

Qualifications:

• Bachelor's degree required.


• Must have 1-year related post-bachelor's degree clinical research experience

Ability to work independently and as a team member


High degree of computer literacy


Analytical skills and ability to resolve technical problems


Ability to interpret acceptability of data results


Working knowledge of data management program


May assist with the training and orientation of new staff members


Provides informational guidance and support to team members



Additional Job Details (if applicable)


Additional Job Description



Remote Type


Onsite



Work Location


45 Francis Street



Scheduled Weekly Hours


40



Employee Type


Regular



Work Shift


Day (United States of America)



EEO Statement:


The Brigham and Women's Hospital, Inc. is an Affirmative Action 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. 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.



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. Apply Now