Works independently under general supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. Will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting.
Position location: Foxborough, MA
Essential Functions Coordinate patient appointments with physicians, nurses, and all test areas. Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition. 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. Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study. Collect, complete, and submit essential regulatory documents to various regulatory entities. Education Bachelor's Degree Related Field of Study required 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 acceptability of data results. - Careful attention to detail. - Good organizational and communication skills. - Working knowledge of clinical research protocols.
The Brigham and Women's Hospital, Inc. 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. 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.
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