Clinical Research Associate Digital CRO Job

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About Us:
As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system. Founded by Brigham and Women's Hospital and Massachusetts General Hospital, Mass General Brigham supports a complete continuum of care including community and specialty hospitals, a managed care organization, a physician network, community health centers, home care and other health-related entities. Several of our hospitals are teaching affiliates of Harvard Medical School, and our system is a national leader in biomedical research.


We're focused on a people-first culture for our system's patients and our professional family. That's why we provide our employees with more ways to achieve their potential. Mass General Brigham is committed to aligning our employees' personal aspirations with projects that match their capabilities and creating a culture that empowers our managers to become trusted mentors. We support each member of our team to own their personal development-and we recognize success at every step.


Our employees use the Mass General Brigham values to govern decisions, actions and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration.



GENERAL SUMMARY / OVERVIEW
The Digital Clinical Research Organization (CRO) aims to improve healthcare through the translation of machine learning algorithms to clinically regulated products to be used at the clinical point of care.


Acting under the supervision of the Director of Clinical Operations, Digital CRO, and following established policies and procedures, the Clinical Research Associate (CRA) is responsible for executing clinical research studies related to AI model validation and regulatory submission preparation, while maintaining proper study documentation.



PRINCIPAL DUTIES AND RESPONSIBILITIES
Execute clinical research activities to measure the efficacy of AI models as per study guidelines and protocols.


Ensure projects follow proper workflow and meet all IRB, legal, and regulatory mandates.


Responsible for collecting data and maintaining patient information database for study.


Responsible for curating study data, data mining of archive (with emphasis on radiology imaging archive), selection of appropriate records based on protocol inclusion criteria, and images review for labelling and quality assurance.


Provide support and execute on regulatory submissions.


Develop documentation and reports required for presenting the outcomes of trials and validations. These reports will be used by clients for FDA submission and the candidate should rapidally become knowledgable about the key requirements associated with FDA submissions.


Maintain professional knowledge and expertise, keeping abreast of new protocols for clinical trials and validation procedures.



Qualifications
Bachelor's degree in Sciences (e.g., Biology, Chemistry), Engineering, Computer Science, Business or related field.


4 years of experience working in Clinical Development, CRO or related environment, is required and 2 years of experience in the Radiological, Pharmaceutical, Biotechnology, or Medical Device industry is preferred.


Experience in healthcare and exposure to the fields of data science and Software as a Medical Device (SaMD) is strongly preferred.


General knowledge of regulatory requirements and GCP.


Demonstrable knowledge of clinical research protocols (at least 5 studies executed).


Knowledge of technologies utilized within radiology informatics solutions including software (RIS, PACS, image viewer and reporting software), databases (SQL), and standards (DICOM) - a strong plus.


Use the Partners HealthCare values to govern decisions, actions and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration.



SKILLS / COMPETENCIES
Excellent interpersonal skills are required.


Good oral and written communication skills.


Excellent organizational skills, careful attention to detail, and ability to prioritize tasks.


Proactive problem solving - the ability and willingness to identify challenges and roadblocks are proactively propose solutions.


Proficiency in MS Office, including Outlook Calendar, Word, Excel and, PowerPoint.



WORKING CONDITIONS
Standard office environment with local travel to Partners' sites and sites within the Boston area


Some travel (
Mass General Brigham is an Equal Opportunity 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.


Partner's Healthcare is acting as an Employment Agency in relation to this vacancy.
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

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