Working under general supervision of a principal investigator, manager or project leader and following established policies and procedures, aids with research studies.
May be responsible for the following activities: collecting and organizing study data; scheduling appointments; tracking equipment use, calibration, location; ordering supplies and equipment; transferring samples/specimen; maintaining and updating data generated by the study; maintaining regulatory documentation; tracking expenditures.
PRINCIPAL DUTIES AND RESPONSIBILITIES: 1. Coordinates the implementation, both internally and externally, of sponsored or internally funded clinical research studies. 2. Initiates and maintains contact with study participants. Responsible for screening applicants, ensuring they meet appropriate criteria, and makes independent judgment as to the suitability of their participation. Assist patients to fill out surveys and ensure completion. May be required to perform clinical tests such as urinalysis, voiding diaries, medication pill count, etc. 3. Working in concert with Principal Investigator and/or Research Manager, designee, or researchers from other divisions, develops and implements subject recruitment strategies, obtains patient consent, develops and administers study surveys. 4. Develops, organizes, and/or maintains the study database. Responsible for chart review, data collection, data validation and quality control. 5. Interacts with subjects with regard to study, including patient education, procedural instruction, follow-up. May serve as a liaison between subject and physician. 6. In conjunction with Research Manager/Principal Investigator, develops and implements new research protocols including design, data collection systems and institutional review board approval. 7. Recommends changes to research protocols. 8. Performs literature searches, as appropriate. 9. Assists PI or Research Manager with preparation for presentation and written published articles. 10. Assists with regulatory documentation as directed by project manager. 11. Responsible for training and orienting new staff. May serve as a team leader or in a supervisory capacity in a smaller area. 12. Organizes and processes study data. Creates and maintains databases/files containing study data using standard Division practices. Assists in preparation and submission of IRB documents, other applications, as well as grants. 13. Assists Investigators and other study personnel in executing studies. Carries out standard and study-specific events as outlined in the study orders, SOPs, and other written documents. Drafts and/or modifies written procedures for study-specific events/data procedures. Acts as a liaison between Investigators, hospital staff, administrative staff, subject recruiters, and research subjects to identify areas for quality and workflow improvements. 14. Assists Investigator in research activities. Performs literature searches, reviews literature, enters papers into reference database, compiles and checks reference lists for manuscripts, grants, and other written reports. 15. Follows Infection Control, Electrical Safety, Radiation Safety and other guidelines as mandated by BWH, OSHA, or other regulatory agencies; follows HIPPA and Human Research guidelines as mandated by DHHS. Follows all standard operating procedures for Obstetrics and Gynecology, the Center for Clinical Investigation, and BWH; follows study-specific procedures. 16. All other duties as specified. QUALIFICATIONS: 1. BA or BS degree in health science, biology, neuroscience, psychology, or related area. 2. Strongly prefer individual with prior experience working with subjects/patients and working on a research team. 3. Computer program proficiency (Microsoft Office Suite) 4. Minimum two-year commitment SKILLS/ ABILITIES/ COMPETENCIES REQUIRED: * Ability to work independently in a busy, research, academic, open office setting with other employees. * Excellent organizational skills and ability to prioritize a variety of tasks. * Careful attention to detail. * Excellent interpersonal skills are required. * Good oral and written communication skills. * Working knowledge of computer programs, databases, etc. * Ability to learn new skills and procedures quickly and perform them independently. * Ability to demonstrate professionalism and respect for subject rights and individual needs. * Must be able to be HIPAA compliant at all times.
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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